Trial NCT04357340
Publication Javaherian M, medRxiv, 2021 (preprint)
Dates: 2020-04-01 to 2020-04-30
Funding: Public/non profit (Tehran University of Medical Sciences)
Conflict of interest: No
| Methods | |
| RCT Blinding: single blinding | |
| Location :
Single center / Iran Follow-up duration (days): 90 | |
| Inclusion criteria | 18 to 75 years old; with confirmed COVID-19 by positive reaction real-time polymerase chain reaction test and presence of ground-glass opacification in their chest computed tomography scan (CT-scan); severe stage of COVID-19 pneumonia indicated by peripheral blood oxygen saturation (Spo2) < 90% after two-minute breathing the free air and respiratory rate > 30 breaths/min; with O2 saturation < 90%; with full consciousness and oriented; able to walk; 100 ≤ PaO2/FiO2 ≤ 200 mmHg, and able to read and write in Persian. |
| Exclusion criteria | Presence of any type of musculoskeletal disorder prohibits the patient from participating in the study; history of intubation due to COVID-19 pneumonia; and any type of obvious clinically mental or cognitive impairment |
| Interventions | |
| Treatment
Pulmonary physiotherapy * |
|
| Control
Standard care ( / ) Definition of Standard care: Usual medical and nursing care, one session of breathing education with 40 minutes duration includes effective cough; if they felt EPS, diaphragmatic breathing, and upper chest muscles relaxation. They also received an incentive spirometer (IS) and instructions on how to use it. They also were advised to walk as tolerated, even using portable oxygen cylinder. | |
| Participants | |
| Randomized 40 participants (n1=20 / n2= 20) | |
| Characteristics of participants N=40 Mean age : 55.5 13 males Severity : Mild: n=0 / Moderate: n=0/ Severe: n=40 Critical: n=0 | |
| Primary outcome | |
| In the register Mixed venous O2 pressure (PVO2) [ Time Frame: Baseline ] Partial pressure of oxygen in mixed venous blood. Mixed venous O2 pressure (PVO2) [ Time Frame: Day 3 ] Partial pressure of oxygen in mixed venous blood. Mixed venous CO2 pressure (PVCO2) [ Time Frame: Baseline ] Partial pressure of carbon dioxide in mixed venous blood. Mixed venous CO2 pressure (PVCO2) [ Time Frame: Day 3 ] Partial pressure of carbon dioxide in mixed venous blood. PH [ Time Frame: Baseline ] Measure of the venous blood acidity or alkalinity PH [ Time Frame: Day 3 ] Measure of the venous blood acidity or alkalinity HCO3 [ Time Frame: Baseline ] The amount of bicarbonate ion in the venous blood HCO3 [ Time Frame: Day 3 ] The amount of bicarbonate ion in the venous blood Oxygen saturation (O2 Sat) from VBG [ Time Frame: Baseline ] The amount of oxygen-saturated hemoglobin relative to total hemoglobin (unsaturated + saturated) in the venous blood Oxygen saturation (O2 Sat) from VBG [ Time Frame: Day 3 ] The amount of oxygen-saturated hemoglobin relative to total hemoglobin (unsaturated + saturated) in the venous blood Three minute walk test [ Time Frame: Baseline ] The distance a patient can walk during three minute Three minute walk test [ Time Frame: Day 3 ] The distance a patient can walk during three minute O2 Sat after one minute walking [ Time Frame: Baseline ] O2 Sat after one minute walking [ Time Frame: Day 3 ] O2 Sat after two minutes use of Partial Rebreather [ Time Frame: Baseline ] O2 Sat after two minutes use of Partial Rebreather [ Time Frame: Day 3 ] O2 Sat after two minutes free air breathing [ Time Frame: Baseline ] O2 Sat after two minutes free air breathing [ Time Frame: Day 3 ] O2 sat/ Fio2 [ Time Frame: Baseline ] O2 sat/ Fio2 [ Time Frame: Day 3 ] | |
| In the report Venous blood O2 & CO2 pressures (pO2 & pCO2, mmHg) from VBG analysis, Spo2, and three-minute walking test(3MWT) that were assessed before and end of sixth session. | |
| Documents available |
Protocol NR Statistical plan NR Data-sharing stated Yes |
| Risk of bias Overall The overall risk of bias reported in the table corresponds to the highest risk of bias for the outcomes assessed for the systematic review |
Some concerns |
| General comment | In addition to the pre-print article, the retrospecive study registry was used in data extraction and risk of bias assessment. The study achieved the target sample size specified in the trial registry. Intervention treatment in the register mentions "Chest expansion exercises," but this was not presented in the report. There were some primary outcomes mentioned in the register not reported as such in the paper (e.g. Measure of the venous blood acidity or alkalinity, The amount of bicarbonate ion in the venous blood).Some outcomes from the registry are not reported in the paper (e.g. mortality at 3 months). Adverse events were reported only in the intervention group. |