Trial IRCT20201012049010N1
Publication Bargahi M, medRxiv, 2021 (preprint)
Dates: 2020-08-15 to 2020-10-31
Funding: Public/non profit (Qazvin University of Medical Science)
Conflict of interest: No
| Methods | |
| RCT Blinding: Unblinded | |
| Location :
Single center / Iran Follow-up duration (days): 3 | |
| Inclusion criteria | Age ≥ 18 year; definitive covid-19 diagnosis (RTPCR+ / chest CT +); first day of admission in the ward; presence of dyspnea according to the patient’s statement; peripheral oxygen saturation (SpO2) <94% |
| Exclusion criteria | Pregnancy; history of lung disease (under treatment), kidney disease (under treatment), heart disease, or neurological disease; allergy to latex or balloon material; contraindication to intense aerobic activity by a physician; need for hospitalization in the ICU/CCU based on the diagnostic and treatment flowchart of the Ministry of Health |
| Interventions | |
| Treatment
Balloon-Blowing 5x5 times per day in the supine position for 3 days |
|
| Control
Standard care ( / ) Definition of Standard care: Both groups received the same drug treatment regimen determined by the relevant medical team | |
| Participants | |
| Randomized 83 participants (n1=42 / n2= 41) | |
| Characteristics of participants N=83 Mean age : 57.6 49 males Severity : Mild: n=0 / Moderate: n=0/ Severe: n=83 Critical: n=0 | |
| Primary outcome | |
| In the register 1) Intensity of dyspnea at rest; 2) Intensity of dyspnea after 50 meters of walking with pulse oximeter; 3) Oxygen saturation of arterial blood without oxygen therapy; 4) Arterial blood oxygen saturation with oxygen therapy | |
| In the report NR | |
| Documents available |
Protocol NR Statistical plan NR Data-sharing stated
|
| 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 |
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| General comment |
This trial is pending contact with authors.
In addition to the pre-print article, the trial registry was used in data extraction and assessment of risk of bias. Neither protocol nor statistical analysis plan was available. The registry was retrospective and there are no difference between the outcomes included there or in the article. The pilot study was conducted to estimate the sample size needed for future studies. No COVID NMA outcomes were reported. |