Comparison of the effect of the integrated drug- incentive spirometry therapy with drug therapy alone on recovery and mortality of patients admitted to hospital with Covid 19

Evaluation of the effectiveness of integrated drug therapy and respiratory training with incentive spirometer on mortality and recovery rates of adult patients admitted to hospital with Covid 19.

A clinical trial with the control group, with parallel groups, three-way blind, randomized, phase 3 on 160 patients. Randomization will be performed using the rand function of Excel software.

Participants are among 19 patients admitted to the non-intensive care unit of Imam Hussein Hospital in Tehran. Patients will be divided into intervention and control groups. Both study groups receive the same drug and non-drug treatments according to the latest published version of the national protocol. The case group will perform breathing exercises according to the study protocol. By assigning a dedicated code to participants, data collectors, treatment teams, patients, and analysts are blinded to group assignments.

Patients with definite Covid19, greater equal 18 years old with peripheral oxygen levels less than 94% who do not require intensive care, no pregnancy, and no history of chronic lung or heart disease.

Eligible patients will be divided into two groups of 80, control and intervention. Both groups receive the same drug treatment according to the declared protocol. In addition, the intervention group was asked to perform breathing exercises with an encouraging spirometer on a daily basis.

-Clinical recovery rate -Severity Dyspnea based on Modified Borg 0-10 scale (MBS) -Blood pressure; Heart rate; Respiratory rate; Symptoms of respiratory distress in the form of intercostal and sternal retraction and use of respiratory sub-muscles; O2 sat (pulse oximetry) in two modes with/without (oxygen therapy)

The sampling method in this study was based on Simple randomization (random numbers table). To create a random list in Excel software, 160 samples (two identical groups of 80) were considered in one column, then the RAND function was assigned. In the end, the samples were sorted from low to high. On a daily basis, eligible patients were assigned by the registrants based on the embedded list in two groups: A) control and B) intervention. Registrants, outcome assessors, and the relevant health care team were not aware of the randomization process.

Eligible patients were divided into two groups by a two-person group of researchers based on a designed table. For one of the patients, a data collection form with a special code will be determined at the time of enrollment. The data were collected by a separate team of collectors on a daily basis and recorded in a designed online data sheet. Health care providers and the treatment team were also unaware of the allocation of patients to either group. The collected data will be statistically analyzed by the analysis group in groups A and B without group-specific labels.

All collected data can be subscribed in CSV format after identifying the participants. And videos taken from patients during breathing exercises can also be shared if they are satisfied.

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