Variable versus conventional lung protective mechanical ventilation during open abdominal surgery (PROVAR) - A randomized controlled trial

Abstract Background: Surgical site infection (SSI) after abdominal surgery is still a significant morbidity associated with an increased socioeconomic burden and poor quality of life. SSI prevalence rates as high as 40% in cases of fecal contamination have been reported; however, current methods to reduce SSI are limited to elective abdominal surgery. Further evaluation of preventive measures for reducing SSI is necessary. Methods/design: The COVER trial investigates whether the application of a dual-ring circular plastic wound protector reduces the rate of SSI in patients undergoing open abdominal surgery related to the gastrointestinal (GI) tract, regardless of the type of wound classified by the Center for Disease Control (CDC). The COVER trial is a multicenter, randomized controlled clinical trial with two parallel arms – one using a wound protector and the other using conventional surgical dressing gauze. The primary outcome will measure the rate of SSI in two groups. Statistical analysis of the primary end point will be based on the intention-to-treat population. The sample size is determined to achieve a study power of 80% at 95% 2-sided confidence limits. Considering a dropout rate of up to 5%, a total of 458 patients, 229 patients in each group, will be enrolled in this study. Discussion: The COVER trial will provide high-quality evidence for using a circular polyethylene drape in open abdominal surgery for the GI tract in all types of wound. The design of the trial will deliver high external validity and clinical significance. Trial registration: The trial protocol was registered at ClinicalTrials.gov (NCT 03170843) on May 31, 2017. https://clinicaltrials.gov/ct2/show/NCT03170843?term=NCT+03170843&rank=1 Keywords: Circular polyethylene drape, Abdominal surgery, Gastrointestinal tract, Surgical site infection, Randomized controlled trial

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Pleth variability index or stroke volume optimization during open abdominal surgery: a randomized controlled trial

BMC Anesthesiology ◽

10.1186/s12871-018-0579-4 ◽

2018 ◽

Vol 18 (1) ◽

Cited By ~ 3

Author(s):

Hans Bahlmann ◽

Robert G. Hahn ◽

Lena Nilsson

Keyword(s):

Randomized Controlled Trial ◽

Abdominal Surgery ◽

Stroke Volume ◽

Controlled Trial ◽

Pleth Variability Index ◽

Randomized Controlled ◽

Open Abdominal Surgery ◽

Variability Index

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Lung-protective mechanical ventilation for patients undergoing abdominal laparoscopic surgeries: a randomized controlled trial

BMC Anesthesiology ◽

10.1186/s12871-021-01318-5 ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

Trung Kien Nguyen ◽

Viet Luong Nguyen ◽

Truong Giang Nguyen ◽

Duc Hanh Mai ◽

Ngoc Quynh Nguyen ◽

...

Keyword(s):

Mechanical Ventilation ◽

Controlled Trial ◽

Arterial Oxygen ◽

Lung Protective Ventilation ◽

Pulmonary Mechanics ◽

Controlled Clinical Trial ◽

Randomized Controlled ◽

Protective Mechanical Ventilation ◽

Postoperative Atelectasis ◽

Lung Protective Mechanical Ventilation

Abstract Background Pneumoperitoneum and Trendelenburg position in laparoscopic surgeries could contribute to postoperative pulmonary dysfunction. In recent years, intraoperative lung-protective mechanical ventilation (LPV) has been reportedly able to attenuate ventilator-induced lung injuries (VILI). Our objectives were to test the hypothesis that LPV could improve intraoperative oxygenation function, pulmonary mechanics and early postoperative atelectasis in laparoscopic surgeries. Methods In this randomized controlled clinical trial, 62 patients indicated for elective abdominal laparoscopic surgeries with an expected duration of greater than 2 h were randomly assigned to receive either lung-protective ventilation (LPV) with a tidal volume (Vt) of 7 ml kg− 1 ideal body weight (IBW), 10 cmH2O positive end-expiratory pressure (PEEP) combined with regular recruitment maneuvers (RMs) or conventional ventilation (CV) with a Vt of 10 ml kg− 1 IBW, 0 cmH2O in PEEP and no RMs. The primary endpoints were the changes in the ratio of PaO2 to FiO2 (P/F). The secondary endpoints were the differences between the two groups in PaO2, alveolar-arterial oxygen gradient (A-aO2), intraoperative pulmonary mechanics and the incidence of atelectasis detected on chest x-ray on the first postoperative day. Results In comparison to CV group, the intraoperative P/F and PaO2 in LPV group were significantly higher while the intraoperative A-aO2 was clearly lower. Cdyn and Cstat at all the intraoperative time points in LPV group were significantly higher compared to CV group (p < 0.05). There were no differences in the incidence of atelectasis on day one after surgery between the two groups. Conclusions Lung protective mechanical ventilation significantly improved intraoperative pulmonary oxygenation function and pulmonary compliance in patients experiencing various abdominal laparoscopic surgeries, but it could not ameliorate early postoperative atelectasis and oxygenation function on the first day after surgery. Trial registration https://www.clinicaltrials.gov/identifier: NCT04546932 (09/05/2020).

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