Comparative study of analgesia nociception index (ANI) vs. standard pharmacokinetic pattern for guiding intraoperative fentanyl administration among mastectomy patients

Abstract Background The Analgesia Nociception Index (ANI) has been suggested as a non-invasive guide for analgesia. Our objective was to compare the efficacy of ANI vs. standard pharmacokinetic pattern for guiding intraoperative fentanyl administration. Methods This was a prospective, randomized, controlled study of adult female patients undergoing elective mastectomy under general anesthesia. The patients were randomized to the ANI-guided group receiving a loading dose of 75 μg of fentanyl followed by 25 μg when the ANI score was under 50. The Control group received the same loading dose followed by 25 μg every 30 min with additional doses when there were signs of inadequate analgesia (viz., tachycardia or hypertension). Results Sixty patients—30 in each group—were recruited. Although the actual mean ANI score was higher in the ANI-guided than in the Control group (mean difference 2.2; 95% CI: 0.3 to 4.0, P = 0.022), there was no difference in the primary outcome—i.e., intraoperative fentanyl consumption (mean difference − 4.2 μg; 95% CI: − 24.7 to 16.4, P = 0.686 and − 0.14 μg·kg− 1·h− 1; 95% CI: − 0.31 to 0.03, P = 0.105). No difference between groups was shown for either intraoperative blood pressure and heart rate, or for postoperative outcomes (i.e., pain scores, morphine consumption, or sedation scores) in the postanesthesia care unit. Conclusions Intraoperative fentanyl administration guided by ANI was equivalent to that guided by a modified pharmacologic pattern. In a surgical model of mastectomy, the ANI-guided intraoperative administration of fentanyl had no impact on clinical outcomes. Trial registration The study was registered with ClinicalTrials.gov (NCT03716453) on 21/10/2018.

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Adding dexmedetomidine to morphine-based analgesia reduces early postoperative nausea in patients undergoing gynecological laparoscopic surgery: a randomized controlled trial

BMC Anesthesiology ◽

10.1186/s12871-019-0928-y ◽

2020 ◽

Vol 20 (1) ◽

Author(s):

Huai Jin Li ◽

Shan Liu ◽

Zhi Yu Geng ◽

Xue Ying Li

Keyword(s):

Laparoscopic Surgery ◽

Postoperative Nausea ◽

Controlled Trial ◽

High Risk Patient ◽

Current Control ◽

Nausea And Vomiting ◽

Controlled Study ◽

Control Group ◽

Loading Dose ◽

Link Type

Abstract Background Few studies have investigated the effect of dexmedetomidine on postoperative nausea and vomiting (PONV) in patients underwent gynecological laparoscopic surgery. We investigated if adding dexmedetomidine to a morphine-based patient-controlled analgesia (PCA) could decrease the incidence of PONV in this high-risk patient population. Methods In this prospective, randomized, double-blind and placebo-controlled study, 122 patients underwent gynecological laparoscopic surgery were assigned into two groups. Patients in the dexmedetomidine group (Group Dex) received a loading dose of dexmedetomidine 0.4 μg/kg before the end of surgery, followed by morphine 0.5 mg/ml plus dexmedetomidine 1 μg/ml for postoperative i.v. PCA. Patients in the control group (Group Ctrl) received normal saline before the end of surgery, followed by morphine 0.5 mg/ml alone for postoperative i.v. PCA. PCA pump was programmed as followed: bolus dose 2 ml, lockout interval 8 min and background infusion at a rate of 1 ml/h. The primary outcome was the incidence of nausea and vomiting within the first postoperative 24 h. Results Although there were no significant differences in regard to the total incidence of PONV (41.0% vs 52.5%, P = 0.204), PONV score, time to first onset of PONV, or the need for rescue antiemetics within the first postoperative 24 h between the two groups, the incidence of nausea and total PONV during the first 2 h period was significantly lower in the Group Dex than in the Group Ctrl (9.8% vs 24.6%, P = 0.031 and 0.031, respectively). More patients in Group Dex were over sedated or had bradycardia during the PACU compared with Group Ctrl (P = 0.040 and 0.036, respectively). Conclusion Our protocol in which dexmedetomidine was administered postoperatively – after a loading dose – to intravenous PCA morphine in patients undergoing gynecological laparoscopic surgery, had only early antiemetic effects, while no clinically meaningful antiemetic effect could be evidenced within the first 24 h after surgery. Trial registration Current control trial registered at Chictr.org.cn: ChiCTR1800017172. Date registered: 07/16/2018.

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The Effect of Lullaby Intervention on Anxiety and Prenatal Attachment in Women with High-Risk Pregnancy: A Randomized Controlled Study

Complementary Medicine Research ◽

10.1159/000520139 ◽

2021 ◽

pp. 1-9

Author(s):

Nazlı Baltacı ◽

Mürüvvet Başer

Keyword(s):

High Risk ◽

Intervention Group ◽

Group Versus ◽

Mean Difference ◽

High Risk Pregnancy ◽

Controlled Study ◽

Control Group ◽

Prenatal Attachment ◽

Randomized Controlled ◽

Risk Pregnancy

Background: Women with high-risk pregnancy experience anxiety and low mother-fetal attachment when faced with signs of danger and health problems. This study aimed to investigate the effects of lullaby intervention on anxiety and prenatal attachment in women with high-risk pregnancy. Materials and Methods: This randomized controlled trial was conducted in the perinatology clinic of a state maternity hospital in Turkey. Seventy-six women with high-risk pregnancy were included. The intervention group listened to lullabies for 20 min once a day, and accompanied by lullabies touched their abdomen and thought about their babies, but the control group did not. Data were collected using the Pregnant Information Form, the State Anxiety Inventory, and the Prenatal Attachment Inventory. Results: Baseline anxiety did not differ in the intervention versus control group (47.83 ± 10.74 vs. 44.10 ± 8.08, mean difference 3.73 [95% Cl –1.18 to 8.64], p = 0.13), but after the 2nd day lullaby intervention anxiety was lower in the intervention group versus control group (33.66 ± 9.32 vs. 43.06 ± 8.10, mean difference –9.40 [95% Cl –13.91 to –4.88], p < 0.01). Baseline prenatal attachment did not differ in the intervention versus control group (56.03 ± 10.71 vs. 53.86 ± 9.98, mean difference 2.16 [95% Cl –3.18 to 7.51], p = 0.42), but after the 2nd day lullaby intervention prenatal attachment was higher in the intervention group versus control group (66.70 ± 7.60 vs. 54.36 ± 9.52, mean difference 12.33 [95% Cl 7.87 to 16.78], p < 0.01). In the within-group analysis the intervention group had lower anxiety and better prenatal attachment (p < 0.01), but not in the control group (p > 0.05). Conclusion: Lullaby intervention can play an effective role in reducing anxiety and improving prenatal attachment. The use of this integrative, noninvasive, non-pharmacologic, time-efficient, and natural intervention is suggested in the care of pregnant women.

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Efficacy of Dexmedetomidine Infusion Without Loading Dose on Hemodynamic Variables and Recovery Time During Craniotomy: A Randomized Double-Blinded Controlled Study

Anesthesiology and Pain Medicine ◽

10.5812/aapm.113410 ◽

2021 ◽

Vol 11 (2) ◽

Author(s):

Ismail Mohammed Ibrahim ◽

Rania Hassan ◽

Raham Hasan Mostafa ◽

Mayada Ahmed Ibrahim

Keyword(s):

Recovery Time ◽

Controlled Study ◽

Control Group ◽

Loading Dose ◽

Hemodynamic Stability ◽

Arterial Blood ◽

Postoperative Intensive Care ◽

Double Blinded ◽

Group D ◽

Dexmedetomidine Infusion

Background: Maintaining hemodynamic stability during intracranial surgery is one of the most important tasks. There is no general agreement regarding which anesthetics are optimal for craniotomy. Propofol and short-acting opioids are usually used, but their use is not without side effects. Recently, dexmedetomidine has been considered a safe alternative in different surgeries. Objectives: We aimed to assess the efficacy of 0.5 µg/kg/h dexmedetomidine infusion without loading dose as an adjunct to general anesthesia for craniotomy. Methods: A prospective, randomized, double-blinded, parallel-group, placebo-controlled trial was conducted. Setting: Single university teaching hospital’s operating rooms and postoperative intensive care unit. Patients: A total of 50 patients scheduled for elective supratentorial craniotomy participated in this study. Interventions: Patients were randomly divided into either control group (Group C) and Dexmedetomidine group (Group D). Main outcome measure: Intraoperative hemodynamics measurements at specific timings. Results: We found that dexmedetomidine had significantly maintained mean arterial blood pressure and heart rate (P-value < 0.001); with lower intraoperative fentanyl and propofol consumption in group D (132 ± 35 µg and 14 ± 30 mg, respectively) when compared to group C (260 ± 38 µg and 534 ± 66 mg, respectively). Finally, a lesser sedation level was noticed in the dexmedetomidine group, together with a significantly lesser recovery time of 10.3 ± 4 min. Conclusions: Dexmedetomidine infusion without loading dose could be an efficacious and safe agent in achieving hemodynamic stability with intraoperative opioid-sparing effect and lesser recovery time.

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Evaluation of a digitally enhanced cardiac auscultation learning method: a controlled study

BMC Medical Education ◽

10.1186/s12909-021-02807-4 ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

Fred-Cyrille Goethe Doualla ◽

Georges Bediang ◽

Chris Nganou-Gnindjio

Keyword(s):

Medical Students ◽

Teaching Method ◽

Intervention Group ◽

Controlled Study ◽

Control Group ◽

Learning Method ◽

Cardiac Auscultation ◽

Link Type ◽

Digitally Enhanced ◽

Clinical Internship

Abstract Background Cardiac auscultation remains an efficient and accessible diagnostic tool, especially in resource-limited countries where modern diagnostic devices like cardiac ultrasound are expensive and difficult to access. However, cardiac auscultation skills of medical students and physicians are declining, mainly because of an ineffective teaching method for this technique. The objective of this study is to evaluate the effect of a digitally enhanced cardiac auscultation learning method on participants’ theoretical knowledge and auscultation skills. Methods This will be a controlled study with two parallel arms (1:1). Participants (fourth-year medical students) will be divided into two groups: an intervention group (receiving additional lectures, clinical internship and audio listening sessions) and a control group (receiving additional lectures and clinical internship). At the beginning of the study, all participants will undergo a pre-test that consist of two parts: a knowledge assessment based on multiple-choice questions and a skills assessment based on recognition of cardiac sounds from audio files. Thereafter, three specific additional lectures on cardiac auscultation will be delivered and all participants will take part in their official clinical internship. During these clinical internships (eight weeks), participants of the intervention group will be invited to two listening sessions based on five digital recordings of heart sounds. At the end of the clinical internship, all participants will be invited to a post-test to evaluate their knowledge, skills and satisfaction according to their learning method. The main outcome will be the participants’ knowledge progression. The other outcomes will be the participants’ skills progression, participants’ total progression and satisfaction. Data will be collected and analyzed in per protocol. Discussion This study could contribute to the development of a learning method that takes into account the advantages of the conventional method and the contribution of digital technology. Positive results could lead to improved cardiac auscultation skills among health professionals, especially in developing countries. Trial registration The trial is registered on the Pan-African Clinical Trials Registry (http://www.pactr.org) under unique identification number: PACTR202001504666847, registered the 29 November 2019.

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815 Australian Surgery Trainee Education for Contemporary Airway Management of OSA: A Pilot Randomised Controlled Study

SLEEP ◽

10.1093/sleep/zsab072.812 ◽

2021 ◽

Vol 44 (Supplement_2) ◽

pp. A318-A319

Author(s):

Nathan Hayward ◽

Anders Sideris ◽

Nathaniel Marshall ◽

Michael Burri ◽

Stuart G Mackay

Keyword(s):

Test Performance ◽

Formal Education ◽

Multiple Choice ◽

Educational Material ◽

Mean Difference ◽

Controlled Study ◽

Control Group ◽

Multiple Choice Questions ◽

Formal Curriculum ◽

Sleep Surgery

Abstract Introduction In Australia, ASOHNS delivers no formal curriculum for training of OHNS, or levels of competency required, to assess and treat complex OSA patients. Australian OHNS trainee confidence, knowledge and exposure to complex multi-level OSA surgery is lacking. Lack of exposure to sufficient complex OSA surgery case load has been identified as a major weakness in training within a recently published international survey. This study was a randomized clinical trial evaluating the effect of Australian OHNS trainee exposure to education materials compared with no exposure, on Sleep Surgery specific examination performance (multiple choice and short written answer). Methods 70 accredited and 45 unaccredited OHNS trainees were invited to participate in this trial. Participants were randomly assigned to Sleep Surgery educational material exposure or no exposure to those materials. Those randomized to the exposure group were provided educational material and were given 2 weeks exposure time prior to the exam. Each participant then complete an online examin, consisting of 40 multiple choice questions and 1 short answer question (marked by a field expert). Differences between exposure and control group means were tested using independent t-tests. Results 24 trainees were allocated to exposure and 22 to control. 33 participants attempted the examination. The were no significant differences between groups in the multiple choice (mean difference 1.3 ± 1.6 [3.3%], p=0.41) or written exam test scores (mean difference 1.8 ± 1.2 [9.0%], p=0.14). Accredited trainees performed better in the written exam (mean difference 2.6 ± 1.1 [13.0%], p=0.03). The mean test score in a separate exploratory group of 2 sleep fellowship trained OHNS was considerably higher in both exams. Conclusion This study suggests that exposure to formal education material may improve understanding of sleep surgery. Accredited trainees performed better than unaccredited trainees but the difference was small. Poor test performance in both groups may indicate further formal sleep surgery teaching is required in the ASOHNS training curriculum. Further research is required to identify the best ways possible to educate OHNS trainees in the complex and nuanced decision making required for OSA patients. Support (if any) Illawarra Health and Medical Research Institute Grant 2019.

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Cough Suppression during Flexible Bronchoscopy Using Transcutaneous Electric Acupoint Stimulation: A Randomized Controlled Study

Evidence-based Complementary and Alternative Medicine ◽

10.1155/2019/5650413 ◽

2019 ◽

Vol 2019 ◽

pp. 1-11

Author(s):

Wei Zhang ◽

Yi-Xiao Yang ◽

Wei Yu ◽

Si-Hua Qi

Keyword(s):

Oxygen Saturation ◽

Underlying Mechanism ◽

Flexible Bronchoscopy ◽

Controlled Study ◽

Control Group ◽

Oxygen Saturation Level ◽

Link Type ◽

Patient Reported ◽

Transcutaneous Electric Acupoint Stimulation ◽

Acupoint Stimulation

Background and Objective. Transcutaneous electric acupoint stimulation (TEAS) is recommended for its sedative and analgesic effects. We sought to evaluate the effect of TEAS on cough suppression during flexible bronchoscopy (FB) and explore the underlying mechanism. Methods. In this single-center, randomized, single-blind, parallel-controlled study, we randomized 100 patients scheduled for FB into two equal groups treated with or without TEAS (TEAS group and control group). Patients in the TEAS group received 30 min of stimulation at the Hegu (LI4), Neiguan (PC6), and Lieque (LU7) points before FB. The control group underwent the same procedure, but without stimulation. The primary outcome was the intraoperative cough score determined by the bronchoscopist. The secondary outcomes were patient-reported discomfort scores and other procedural parameters. Results. Compared with the controls, patients who received TEAS preconditioning had lower cough scores (P=0.0027) and requirement of lidocaine and fentanyl (P<0.05) and significantly higher postprocedural plasma β-endorphin levels (P=0.0367). There were no intergroup differences in discomfort scores, midazolam dosage, rate of premature termination, oxygen requirement, sedation level, airway assistance, oxygen saturation, lowest oxygen saturation level, heart rate, plasma substance-P levels, and rate of complications after 24 h. The total procedure duration, time for passage of the bronchoscope through the vocal cords, and systolic and diastolic blood pressure levels were less in the TEAS group than in the control group (P=0.033, 0.039 and <0.05, respectively). Conclusion. The combination of midazolam and TEAS was superior to midazolam alone for cough suppression during FB, probably due to increased plasma β-endorphin levels. This trial is registered with ChiCTR1800016612 at chictr.org.cn/index.aspx.

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Effect of surgical pleth index-guided analgesia versus conventional analgesia techniques on fentanyl consumption under multimodal analgesia in laparoscopic cholecystectomy: a prospective, randomized and controlled study

BMC Anesthesiology ◽

10.1186/s12871-021-01366-x ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

Jian Guo ◽

Weigang Zhu ◽

Qinye Shi ◽

Fangping Bao ◽

Jianhong Xu

Keyword(s):

Laparoscopic Cholecystectomy ◽

Blood Glucose ◽

Plasma Cortisol ◽

Adverse Reactions ◽

Multimodal Analgesia ◽

Controlled Study ◽

Control Group ◽

Extubation Time ◽

Fentanyl Consumption ◽

Glucose Plasma

Abstract Background The Surgical Pleth Index (SPI) is an objective tool that can reflect nociception-antinociception balance and guide the use of intraoperative analgesics. Multimodal analgesia has been neglected in many previous studies. The aim of this study was to compare fentanyl consumption using SPI-guided analgesia versus conventional analgesia techniques under multimodal analgesia in laparoscopic cholecystectomy. Methods A total of 80 patients aged 18–65 years with American Society of Anaesthesiologists (ASA) grade I-II and a body mass index (BMI) of 18.5 to 30 kg/m2 who were scheduled for laparoscopic cholecystectomy under total intravenous anaesthesia from March 2020 to September 2020 were selected. Multimodal analgesia, including local infiltration of the surgical incision, nonsteroidal anti-inflammatory drugs and opioids, was adopted perioperatively. Fentanyl boluses of 1.0 µg/kg were administered to maintain the SPI value between 20 and 50 in the SPI group. By contrast, fentanyl boluses of 1.0 µg/kg were administered whenever the heart rate (HR) or mean arterial pressure (MAP) increased to 20 % above baseline or when the HR was greater than 90 beats per minute (bpm) in the control group. Preoperative and postoperative blood glucose, plasma cortisol and interleukin-6 (IL-6) levels were evaluated. Intraoperative haemodynamic events and propofol and fentanyl doses were noted. The extubation time, postoperative visual analogue scale (VAS) score, use of remedial analgesics and opioid-related adverse reactions were recorded. Results In total, 18 of 80 patients withdrew for various reasons, and data from 62 patients were finally analysed. Intraoperative fentanyl consumption was significantly lower in the SPI group than in the control group (177.1 ± 65.9 vs. 213.5 ± 47.5, P = 0.016). The postoperative extubation time was shorter in the SPI group than in the control group (16.1 ± 5.2 vs. 22.1 ± 6.3, P < 0.001). Preoperative and postoperative blood glucose, plasma cortisol and IL-6 levels, intraoperative haemodynamic changes, postoperative VAS scores, remedial analgesic consumption and opioid-related adverse reactions were comparable in the two groups. Conclusions Lower doses of fentanyl are required intraoperatively with shorter extubation times when SPI is used to guide intraoperative analgesia compared to conventional analgesia techniques under multimodal analgesia in laparoscopic cholecystectomy. Trial registration Chictr.org.cn ChiCTR2000030145. Retrospectively Registered (Date of registration: February 24, 2020).

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A Randomized Controlled Study of Caudal Dexmedetomidine for the Prevention of Postoperative Agitation in Children Undergoing Urethroplasty

Frontiers in Pediatrics ◽

10.3389/fped.2021.658047 ◽

2021 ◽

Vol 9 ◽

Author(s):

Weichao Zhu ◽

Jie Sun ◽

Jianhua He ◽

Wangping Zhang ◽

Meng Shi

Keyword(s):

Controlled Study ◽

Postanesthesia Care Unit ◽

Control Group ◽

Sedation Scale ◽

Caudal Block ◽

Clinical Trial Registration ◽

Randomized Controlled ◽

Ramsay Sedation Scale ◽

Group D ◽

Excessive Sedation

Background: Postoperative agitation is a common complication in children undergoing general anesthesia. This study aimed to investigate the effect of caudal dexmedetomidine for the prevention of postoperative agitation in children undergoing urethroplasty.Materials and Methods: Eighty children were prospectively recruited to this study and randomized to two groups (40 cases in each group), specifically, a dexmedetomidine group (group D) who received 0.2% ropivacaine + 0.5 μg/kg dexmedetomidine for caudal block, and a control group who received 0.2% ropivacaine alone. The time to wake up, the time to discharge from the postanesthesia care unit (PACU), the duration of the caudal block, and the Ramsay sedation scale (RSS) were evaluated in the patients. Adverse events such as postoperative agitation, respiratory depression, bradycardia, hypotension, excessive sedation, nausea, and vomiting were also recorded during the first postoperative 24 h.Results: The incidence of postoperative agitation was lower in group D compared with patients in the control group (2.5 vs. 22.5%, p = 0.007). The time to wake up and the time to discharge from PACU were longer in group D than in the control group (15.2 ± 2.6 vs. 13.4 ± 1.3 min, 48.2 ± 7.7 vs. 41.5 ± 8.0 min, respectively, p < 0.001). However, the extubation times were similar between the two groups. The duration of the caudal block was longer in group D compared with the control group (8.8 ± 1.6 vs. 4.6 ± 0.7 h, p < 0.001).Conclusions: Caudal dexmedetomidine prolongs the duration of caudal block and decreases the incidence of postoperative agitation in children undergoing urethroplasty.Clinical Trial Registration: ChiCTR1800016828.

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Effect of Pregabalin on Preoperative Anxiety and Postoperative Pain in Spine Surgery: A Randomized Controlled Study

Journal of Neuroanaesthesiology and Critical Care ◽

10.1055/s-0037-1616037 ◽

2018 ◽

Vol 05 (01) ◽

pp. 8-14

Author(s):

Rahul Yadav ◽

Rajeeb K. Mishra ◽

Arvind Chaturvedi ◽

Girija P. Rath

Keyword(s):

Side Effects ◽

Postoperative Pain ◽

Spine Surgery ◽

Postoperative Nausea And Vomiting ◽

Preoperative Anxiety ◽

Controlled Study ◽

Lumbar Spine Surgery ◽

Control Group ◽

Vas Score ◽

Fentanyl Consumption

Abstract Background Pregabalin is a gabapentinoid which has been shown to possess analgesic and anxiolytic properties. The present study aimed to assess the efficacy of a single dose of pregabalin on postoperative pain and preoperative anxiety in patients undergoing lumbar spine surgery. Materials and Methods Sixty adults posted for elective lumbar laminectomy and discectomy were randomly assigned to one of the three groups; Group C received placebo capsules, Group PI received pregabalin 150 mg, and Group P2 received pregabalin 300 mg capsules, 2 h prior to induction of anesthesia. The levels of anxiety and pain were assessed with respective 100 mm visual analog scale (VAS) score. Postoperative fentanyl consumption and occurrence of side effects were recorded. All patients were observed for 8 h, postoperatively. Results There was a significant reduction in preoperative anxiety in both pregabalin groups as compared to control group (p = 0.001). VAS score for pain (at rest and during movement) was significantly decreased at all time intervals in both PI and P2 groups as compared to control (p < 0.05). Fentanyl consumption in the postoperative period was significantly reduced in pregabalin groups as compared to control (p = 0.001). The level of sedation was higher in P2 group in the first 4 h (p < 0.05). The occurrence of postoperative nausea and vomiting was more in control group as compared to the pregabalin groups (p = 0.018). The incidence of dizziness and blurring of vision was significantly more in P2 group. Conclusion Single preoperative dose of pregabalin 150 or 300 mg was effective in reducing preoperative anxiety, postoperative pain and total fentanyl consumption in patients undergoing lumbar laminectomy and discectomy. However, the incidence of postoperative side effects such as sedation, dizziness and visual blurring was more in patients who received pregabalin 300 mg.

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Extracorporeal CO2 removal in acute exacerbation of COPD unresponsive to non-invasive ventilation

BMJ Open Respiratory Research ◽

10.1136/bmjresp-2021-001089 ◽

2021 ◽

Vol 8 (1) ◽

pp. e001089

Author(s):

Mathilde Azzi ◽

Jerome Aboab ◽

Sophie Alviset ◽

Daria Ushmorova ◽

Luis Ferreira ◽

...

Keyword(s):

Acute Exacerbation ◽

Invasive Mechanical Ventilation ◽

Control Group ◽

Co2 Removal ◽

Complication Rates ◽

Invasive Ventilation ◽

Non Invasive ◽

Link Type ◽

Non Invasive Ventilation ◽

Mean Time

BackgroundThe gold-standard treatment for acute exacerbation of chronic obstructive pulmonary disease (ae-COPD) is non-invasive ventilation (NIV). However, NIV failures may be observed, and invasive mechanical ventilation (IMV) is required. Extracorporeal CO₂ removal (ECCO₂R) devices can be an alternative to intubation. The aim of the study was to assess ECCO₂R effectiveness and safety.MethodsPatients with consecutive ae-COPD who experienced NIV failure were retrospectively assessed over two periods of time: before and after ECCO₂R device implementation in our ICU in 2015 (Xenios AG).ResultsBoth groups (ECCO₂R: n=26, control group: n=25) were comparable at baseline, except for BMI, which was significantly higher in the ECCO₂R group (30 kg/m² vs 25 kg/m²). pH and PaCO₂ significantly improved in both groups. The mean time on ECCO₂R was 5.4 days versus 27 days for IMV in the control group. Four patients required IMV in the ECCO₂R group, of whom three received IMV after ECCO₂R weaning. Seven major bleeding events were observed with ECCO₂R, but only three led to premature discontinuation of ECCO₂R. Eight cases of ventilator-associated pneumonia were observed in the control group. Mean time spent in the ICU and mean hospital stay in the ECCO₂R and control groups were, respectively, 18 vs 30 days, 29 vs 49 days, and the 90-day mortality rates were 15% vs 28%.ConclusionsECCO₂R was associated with significant improvement of pH and PaCO₂ in patients with ae-COPD failing NIV therapy. It also led to avoiding intubation in 85% of cases, with low complication rates.Trial registration numberClinicalTrials.gov, NCT04882410. Date of registration 12 May 2021, retrospectively registered.https://www.clinicaltrials.gov/ct2/show/NCT04882410.

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