scholarly journals Telemanagement of Home-Isolated COVID-19 Patients Using Oxygen Therapy With Noninvasive Positive Pressure Ventilation and Physical Therapy Techniques: Randomized Clinical Trial (Preprint)

2020 ◽  
Author(s):  
Aya Sedky Adly ◽  
Mahmoud Sedky Adly ◽  
Afnan Sedky Adly

BACKGROUND With the growing stress on hospitals caused by the COVID-19 pandemic, the need for home-based solutions has become a necessity to support these overwhelmed hospitals. OBJECTIVE The goal of this study was to compare two nonpharmacological respiratory treatment methods for home-isolated COVID-19 patients using a newly developed telemanagement health care system. METHODS In this single-blinded randomized clinical trial, 60 patients with stage 1 pneumonia caused by SARS-CoV-2 infection were treated. Group A (n=30) received oxygen therapy with bilevel positive airway pressure (BiPAP) ventilation, and Group B (n=30) received osteopathic manipulative respiratory and physical therapy techniques. Arterial blood gases of PaO<sub>2</sub> and PaCO<sub>2</sub>, pH, vital signs (ie, temperature, respiratory rate, oxygen saturation, heart rate, and blood pressure), and chest computed tomography scans were used for follow-up and for assessment of the course and duration of recovery. RESULTS Analysis of the results showed a significant difference between the two groups (<i>P</i>&lt;.05), with Group A showing shorter recovery periods than Group B (mean 14.9, SD 1.7 days, and mean 23.9, SD 2.3 days, respectively). Significant differences were also observed between baseline and final readings in all of the outcome measures in both groups (<i>P</i>&lt;.05). Regarding posttreatment satisfaction with our proposed telemanagement health care system, positive responses were given by most of the patients in both groups. CONCLUSIONS It was found that home-based oxygen therapy with BiPAP can be a more effective prophylactic treatment approach than osteopathic manipulative respiratory and physical therapy techniques, as it can impede exacerbation of early-stage COVID-19 pneumonia. Telemanagement health care systems are promising methods to help in the pandemic-related shortage of hospital beds, as they showed reasonable effectiveness and reliability in the monitoring and management of patients with early-stage COVID-19 pneumonia. CLINICALTRIAL ClinicalTrials.gov NCT04368923; https://clinicaltrials.gov/ct2/show/NCT04368923

10.2196/23446 ◽  
2021 ◽  
Vol 23 (4) ◽  
pp. e23446
Author(s):  
Aya Sedky Adly ◽  
Mahmoud Sedky Adly ◽  
Afnan Sedky Adly

Background With the growing stress on hospitals caused by the COVID-19 pandemic, the need for home-based solutions has become a necessity to support these overwhelmed hospitals. Objective The goal of this study was to compare two nonpharmacological respiratory treatment methods for home-isolated COVID-19 patients using a newly developed telemanagement health care system. Methods In this single-blinded randomized clinical trial, 60 patients with stage 1 pneumonia caused by SARS-CoV-2 infection were treated. Group A (n=30) received oxygen therapy with bilevel positive airway pressure (BiPAP) ventilation, and Group B (n=30) received osteopathic manipulative respiratory and physical therapy techniques. Arterial blood gases of PaO2 and PaCO2, pH, vital signs (ie, temperature, respiratory rate, oxygen saturation, heart rate, and blood pressure), and chest computed tomography scans were used for follow-up and for assessment of the course and duration of recovery. Results Analysis of the results showed a significant difference between the two groups (P<.05), with Group A showing shorter recovery periods than Group B (mean 14.9, SD 1.7 days, and mean 23.9, SD 2.3 days, respectively). Significant differences were also observed between baseline and final readings in all of the outcome measures in both groups (P<.05). Regarding posttreatment satisfaction with our proposed telemanagement health care system, positive responses were given by most of the patients in both groups. Conclusions It was found that home-based oxygen therapy with BiPAP can be a more effective prophylactic treatment approach than osteopathic manipulative respiratory and physical therapy techniques, as it can impede exacerbation of early-stage COVID-19 pneumonia. Telemanagement health care systems are promising methods to help in the pandemic-related shortage of hospital beds, as they showed reasonable effectiveness and reliability in the monitoring and management of patients with early-stage COVID-19 pneumonia. Trial Registration ClinicalTrials.gov NCT04368923; https://clinicaltrials.gov/ct2/show/NCT04368923


2022 ◽  
Vol 9 ◽  
Author(s):  
Robin Hofmann ◽  
Tamrat Befekadu Abebe ◽  
Johan Herlitz ◽  
Stefan K. James ◽  
David Erlinge ◽  
...  

Background: Myocardial infarction (MI) occurs frequently and requires considerable health care resources. It is important to ensure that the treatments which are provided are both clinically effective and economically justifiable. Based on recent new evidence, routine oxygen therapy is no longer recommended in MI patients without hypoxemia. By using data from a nationwide randomized clinical trial, we estimated oxygen therapy related cost savings in this important clinical setting.Methods: The DETermination of the role of Oxygen in suspected Acute Myocardial Infarction (DETO2X-AMI) trial randomized 6,629 patients from 35 hospitals across Sweden to oxygen at 6 L/min for 6–12 h or ambient air. Costs for drug and medical supplies, and labor were calculated per patient, for the whole study population, and for the total annual care episodes for MI in Sweden (N = 16,100) with 10 million inhabitants.Results: Per patient, costs were estimated to 36 USD, summing up to a total cost of 119,832 USD for the whole study population allocated to oxygen treatment. Applied to the annual care episodes for MI in Sweden, costs sum up to between 514,060 and 604,777 USD. In the trial, 62 (2%) patients assigned to oxygen and 254 (8%) patients assigned to ambient air developed hypoxemia. A threshold analysis suggested that up to a cut-off of 624 USD spent for hypoxemia treatment related costs per patient, avoiding routine oxygen therapy remains cost saving.Conclusions: Avoiding routine oxygen therapy in patients with suspected or confirmed MI without hypoxemia at baseline saves significant expenditure for the health care system both with regards to medical and human resources.Clinical Trial Registration:ClinicalTrials.gov, identifier: NCT01787110.


2020 ◽  
Author(s):  
Fatemeh Shabani ◽  
Katayon Vakilian ◽  
Fereshteh Narenji ◽  
Mahbubeh Bozorgi ◽  
Soodabeh Bioos ◽  
...  

Abstract Background Dysmenorrhea is one of the most common pelvic pains in women, impairing their quality of life.This study investigated the effects of chamomile sachet and mefenamic acid on primary dysmenorrhea, associated symptoms and bleeding. Methods In this randomized clinical trial, 200 female students with primary dysmenorrhea from Arak universities were randomly assigned to two groups. The group (A) received mefenamic acid (250 mg) and group (B) received chamomile (5000 mg) plus one teaspoonful of honey )as a flavoring( for two days before up to the first three days of menstruation, three times a day in two consecutive cycles. Pain severity, associated symptoms and bleeding were assessed using visual analog scale, Andersch-Milsom Verbal Scale and Higham chart, respectively. Data were analyzed by descriptive and inferential statistical tests by SPSS 21. Results Severe pain during two months after intervention was in 6 (6.3%) of group (B) and 6 (6.3%) in group (A) (p = 0.351, p = 0.332). Mean severity of associated symptoms two months after the treatment was( 4.93 ± 3.54) in group (B) and (5.62 ± 3.54 ) in group (A), indicating further reduction in group (B) but not significant (p = 0.278). Mean of bleeding was (88.71 ± 66.4 vs. 70.54 ± 53. 34) in group (B) and (A) respectively, in two months later. therefore decrease in the two groups but was not significant between groups(p = 0.567). Conclusions It seems chamomile sachet can reduce the severity of pain and bleeding similar to mefenamic acid and even further mitigate the symptoms associated with dysmenorrhea. Trial registration: This study was performed with the proposal approval code of 2611, ethics code of (ARAKMU.REC.1395.164) at Arak University of medical sciences and code of IRCT 2016100825031N5 on 2016.11.08.


2021 ◽  
Vol 10 (4) ◽  
pp. 3296-3299
Author(s):  
Waqar M. Naqvi

To compare the effect of Land based exercises and Pool based exercises for shoulder strength to reduce shoulder pain in competitive swimmers using Shoulder Pain Disability Index (SPADI) score, Hand-Held dynamometer (HHD), Randomized Clinical trial.29 competitive swimmers with age group between 8 to 18 years were evaluated for shoulder pain using Shoulder Pain Disability Index Score [SPADI] and shoulder strength was evaluated using Hand Held Dynamometer [HHD] before and after the study. Then all the subjects were divided into 2 groups, for Group A Pool based exercises were given and for Group B Land based exercises were given. Statistically there is significant difference in values of outcome measures after the study in both groups but there is more significant difference in Group A than Group B. Pool based exercises showed more significant effect on shoulder pain than land based exercises in swimmer’s shoulder.


2019 ◽  
Vol 49 (1) ◽  
pp. 57
Author(s):  
Yunis Sucipta Ibnu ◽  
Dwi Reno Pawarti ◽  
Mansyur Siddiq Wiyadi

Latar belakang: Rinitis alergi (RA) adalah inflamasi mukosa hidung yang diperantarai oleh IgE. Gejala dapat dinilai dengan Skor Gejala Hidung Total (SGHT). Patofisiologi dan manifestasi klinis RA dipengaruhi oleh berbagai sitokin diantaranya interleukin 33 (IL-33). Efektivitas propolis maupun flavonoid dalam menurunkan SGHT dan kadar IL-33 sekret hidung masih kontroversi. Tujuan: Membuktikan bahwa penambahan propolis pada terapi komplementer RA lebih efektif menurunkan SGHT dan kadar IL-33 sekret hidung. Metode: Penelitian double blind randomized clinical trial (RCT), dilakukan di Unit Rawat Jalan (URJ) Divisi Alergi Imunologi, Departemen Telinga Hidung Tenggorok-Bedah Kepala Leher (THT-KL) RSUD Dr. Soetomo, dan Institute of Tropical Disease, Universitas Airlangga, Surabaya pada bulan September 2018-Januari 2019. Pasien RA yang memenuhi kriteria inklusi diperiksa SGHT dan kadar IL-33 sekret hidung. Terapi diberikan selama 14 hari, evaluasi SGHT dan kadar IL-33 dilakukan hari ke-15. Hasil: Sepuluh sampel mendapat propolis dan terapi standar (kelompok A), sepuluh sampel mendapat terapi standar (kelompok B). Perbandingan SGHT antar kelompok setelah terapi rerata kelompok A=1,6 (SD 1,7), kelompok B=5,2 (SD 1,6). Uji Mann-Whitney satu arah p=0,001 menunjukkan SGHT antar kelompok setelah terapi berbeda signifikan (p<0,005). Rerata kadar IL-33 setelah terapi kelompok A=0,051 (SD 0,005), kelompok B=0,051 (SD 0,013). Uji t nilai p=0,881 menunjukkan kadar IL-33 sekret hidung antar kelompok setelah terapi berbeda tidak signifikan (p>0,005). Kesimpulan: Penambahan propolis sebagai terapi komplementer lebih efektif dalam menurunkan SGHT dibandingkan dengan terapi standar saja, namun tidak efektif dalam menurunkan kadar IL-33 sekret hidung penderita RA. Background: Allergic rhinitis (AR) is a nasal mucosa inflammation mediated by IgE. The symptoms severity is determined by total nasal symptom score (TNSS). The pathophysiology and clinical manifestations of AR are affected by several cytokines, one of which is interleukin 33 (IL-33). Efficacy of propolis or flavonoid in reducing TNSS and IL-33 level in nasal secretion is still a controversy. Purpose: To find out whether propolis addition to standard therapy could be more effective in reducing TNSS and IL-33 level of nasal secretion. Method: Double blind randomized clinical trial (RCT). The study was conducted at Outpatient unit of Department of Allergic and Immunology, Dr. Soetomo General Hospital, Surabaya and Institute of Tropical Disease (ITD) Universitas Airlangga. Allergic rhinitis patients who met inclusion criteria were examined for TNSS and IL-33 nasal secretion level. Therapy was given for 14 days, after which TNSS and IL-33 levels were evaluated on day 15th. Ten samples received propolis and standard therapy (group A), ten samples received standard therapy only (group B). Result: The comparison of TNSS groups after treatment: mean group A=1.6 (SD 1.7), and mean group B=5.2 (SD 1.6). One way Mann-Whitney test showed p=0.001 indicating the TNSS after treatment was significantly different (p<0.005). The comparison of IL-33: mean group A=0.051(SD=0.005) and mean group B=0.051(SD=0.013), t-test p=0.0881 indicating the IL-33 level of nasal secretion after treatment was not significantly different (p>0.005). Conclusion: Propolis as a complementary therapy was more effective reducing TNSS compared to standard therapy only, but it was not effective in reducing IL-33 level of nasal secretion.


10.3823/2558 ◽  
2018 ◽  
Vol 11 ◽  
Author(s):  
Jousilene de Sales Tavares ◽  
Adriana Suely Oliveira Melo ◽  
Suzana Farias Leite ◽  
Alexandre Sergio Silva ◽  
João Guilherme Alves ◽  
...  

Objective:  This study aims to compare maternal and fetal responses during two physical exercise types. Design:  A randomized clinical trial compared 120 pregnant women, gestational age of 35-37 weeks, 56 exercising on a stationary bicycle (Group A) and 64 on a treadmill (Group B). Methods: Participants were monitored for three 20-minute phases: resting, exercise and recovery.  Fetal heart rate (FHR) and maternal heart rate (MHR) were monitored.  Glucose and lactate levels were evaluated at rest and during exercise. Results:  After the beginning of exercise, maximum lactate (L) levels were reached at 20 minutes and never exceeded 4 mmol/l.  FHR decreased by 22 bpm during exercise in relation to resting values, irrespective of the exercise type (p<0.001).  Comparing the exercise types, the incidence of bradycardia after 10’ was 23.2% in Group A and 35.9% in Group B (p>0.05), increasing at 20’ to 32% and 40.6%, respectively, (p>0.05).  The FHR decrease during exercise was accompanied by a simultaneous increase in its variability (p<0.001), nevertheless a rapid return to resting values was observed shortly after exercise end.  Glucose decreased in both groups irrespective of the exercise type (85 mg/dl at rest; 79 mg/dl during exercise and 81 mg/dl during recovery; p<0.001). There were no hypoglycemia cases. Conclusions: FHR variability increase and the rapid return to resting values after exercise suggests that the FHR fall and the presence of bradycardia during exercise is the fetal physiologic response to blood flow redistribution, with maintenance of fetal well-being. Key-words: Exercise; fetal heart rate; glucose; maternal heart rate; pregnancy Clinical Trial Registration: ClinicalTrials.gov, www.clinicaltrials.gov, NCT01383889.


2016 ◽  
Vol 17 (6) ◽  
pp. 659-666 ◽  
Author(s):  
Shima Shahjouei ◽  
Sara Hanaei ◽  
Zohreh Habibi ◽  
Mostafa Hoseini ◽  
Saeed Ansari ◽  
...  

OBJECTIVE No evidence-based guideline has been approved for the postoperative management of pediatric patients with tethered cord syndrome (TCS). The purpose of this randomized clinical trial was to evaluate the effectiveness of prone positioning and acetazolamide administration on complication rates following spinal cord untethering surgeries. METHODS From October 2012 to February 2015, patients with a primary diagnosis of TCS who were admitted to the Children's Medical Center Hospital of Iran were randomly allocated to 1 of 4 intervention modality groups postoperatively: 1) Group A, acetazolamide administration for 10 days; 2) Group B, prone positioning for 10 days; 3) Group C, acetazolamide administration and prone positioning for 10 days; and 4) Group D, no intervention. CSF leakage, CSF collection, wound dehiscence, operative site infection, and secondary surgical wound repair were considered failure. RESULTS A total of 161 patients were enrolled in this study (Group A, n = 39 [24.2%]; Group B, n = 41 [25.5%]; Group C, n = 39 [24.2%]; and Group D, n = 42 [26.1%]). The overall failure rate was 12.42% (20 patients). Complication rates through pooled analyses were as follows: CSF leakage (n = 9, 5.6%), CSF collection (n = 12, 7.5%), wound dehiscence (n = 2, 1.2%), and infection of operation site (n = 3, 1.9%). Two patients (1.2%) required surgical secondary wound repair due to complications. CSF leakage and collection rates were significantly lower in patients who underwent prone positioning (p = 0.042 and 0.036, respectively). The administration of acetazolamide, either isolated or in combination with prone positioning, not only could not significantly lower the complication rates, but also added the burden of side effects. CONCLUSIONS The current study demonstrates the possible role of prone positioning in mitigating the complication rates subsequent to untethering surgeries. Clinical trial registration no.: NCT01867268 (clinicaltrials.gov)


2019 ◽  
Vol 4 (2) ◽  
pp. 126-134 ◽  
Author(s):  
S.S. Gao ◽  
D. Duangthip ◽  
M.C.M. Wong ◽  
E.C.M. Lo ◽  
C.H. Chu

Objectives: The aim of this noninferiority double-blind randomized clinical trial was to compare the effectiveness of the topical semiannual application of a 25% silver nitrate (AgNO3) solution followed by a 5% sodium fluoride (NaF) varnish with that of a 38% silver diamine fluoride (SDF) solution in arresting caries among preschool children. Methods: Healthy 3-y-old children with active dentine carious lesions were randomly allocated to 2 groups via computer-generated random numbers. Lesions in group A received applications of a 25% AgNO3 solution followed by a 5% NaF varnish semiannually (every 6 mo). Lesions in group B received semiannual applications of a 38% SDF solution followed by a placebo varnish. A trained examiner recorded the status of caries and oral hygiene at baseline and during follow-up examinations. The examiner, children, and their caretakers were blinded to the intervention allocation. This study adopted an intention-to-treat analysis. A noninferiority test was conducted for the data analysis. Group A’s noninferiority was accepted if the lower limit of the 95% CI for the difference in the mean number of arrested surfaces was >−0.5. Results: A total of 1,070 children were recruited at baseline, with 535 children in each group. After 18 mo, the mean ± SD number of arrested surfaces was 3.3 ± 3.4 in group A (n = 484) and 3.2 ± 3.5 in group B (n = 476; P = 0.664). The difference in the mean number of arrested surfaces between the groups was 0.092 (95% CI, −0.322 to 0.505). Apart from black staining on the arrested lesions, no other significant side effect was observed. Conclusion: A semiannual application of 25% AgNO3 followed by 5% NaF is no worse than a 38% SDF in arresting dentine caries among preschool children over 18 mo. The Hong Kong Research Grants Council (GRF 17107315) funded this trial, which was registered at ClinicalTrials.gov (NCT02019160). Knowledge Transfer Statement: This randomized clinical trial found that silver nitrate solution followed by sodium fluoride varnish is effective in arresting dentine caries among preschool children. As silver nitrate followed by sodium fluoride is a noninvasive and simple protocol, it can be an alternative strategy to manage dental caries among young children, especially in countries where silver diamine fluoride is not available.


2016 ◽  
Vol 9 (2) ◽  
pp. 256 ◽  
Author(s):  
Hamidollah Afrasiabian ◽  
Mohammad Hadi Imanieh ◽  
Mohammad Ali Nejati ◽  
Alireza Salehi

<p><em>H. pylori</em><strong> </strong>infection is one of the most common infections in the world so that the aim of this study was to evaluate the antimicrobial <em>P. Atlantica Kurdica</em> gum in the eradication of <em>H. pylori</em>. This study is a randomized clinical trial; Patients with positive Urea Breath Test and symptoms of dyspepsia were entered. Patients were randomly divided into four groups. Group A: three drugs including 500 mg of Amoxicillin twice a day (bd), Clarithromycin 500 mg bd and Omeprazole 20 mg (bd) and Group B: Group A drugs plus the capsule containing 1 g of powdered <em>P. Atlantica Kurdica </em>gum (bd). In Group C: the capsule containing 1 g of powdered <em>P. Atlantica Kurdica</em> gum (bd) and Group D: this group took placebo-containing capsule (bd) for 14 days respectively. Dyspeptic symptoms before and after healing period and the UBT results two days before the start of treatment and 30 days after the completion were compared in 4 groups. Patients were not statistically significant difference from each other in the four groups regarding the demographic situation. Moreover, <em>H. pylori</em> eradication rate was 19/24 in Group A, 18/24 in Group B, 10/23 in Group C and 2/24 in Group D. Relieving symptoms of dyspepsia in Groups B and C were significantly higher than in Group D (P=0.025 and p=0.006 respectively). <em>P. Atlantica Kurdica</em> significantly led to the treatment of dyspepsia symptoms and <em>H. pylori</em> eradication.</p>


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