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Trial - IRCT20201012049010N1


Column Value
Trial registration number IRCT20201012049010N1
Full text link
Last imported at : Nov. 13, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)

First author
Last imported at : Nov. 13, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)

Mohammadali emamjomeh

Contact
Last imported at : Nov. 13, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)

research.dpt@qums.ac.ir

Registration date
Last imported at : Nov. 13, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)

2020-11-12

Recruitment status
Last imported at : Nov. 13, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)

Completed

Study design
Last imported at : Nov. 13, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)

RCT

Allocation
Last imported at : Nov. 13, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)

Randomized

Design
Last imported at : Nov. 13, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)

Factorial

Masking
Last imported at : Nov. 13, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)

Blind label

Center
Last imported at : Nov. 13, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)

single-center

Study aim
Last imported at : Nov. 13, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)

Treatment

Inclusion criteria
Last imported at : Nov. 13, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)

≥ 18 years old Patients with definitive diagnosis of Covid-19 Hospitalization in non-intensive care unit dyspnea according to the patient O2-saturation <93% recorded by a pulse oximeter.

Exclusion criteria
Last imported at : Nov. 13, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)

History of lung diseases (under treatment) History of kidney diseases (under treatment) History of heart diseases history of allergy to latex or balloon material Any case of prohibition from Intense aerobic activity by a physician the need for hospitalization in intensive care units(ICU or CCU). Pregnancy History of neurological diseases

Number of arms
Last imported at : Nov. 13, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)

2

Funding
Last imported at : Nov. 13, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)

Qazvin University of Medical Sciences

Inclusion age min
Last imported at : Nov. 13, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)

18

Inclusion age max
Last imported at : Nov. 13, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)

100

Countries
Last imported at : Nov. 13, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)

Iran

Type of patients
Last imported at : Nov. 13, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)

Severe disease at enrollment

Severity scale
Last imported at : Nov. 13, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)

6: Severe disease at enrollment

Total sample size
Last imported at : Nov. 13, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)

90

primary outcome
Last imported at : Nov. 13, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)

Intensity of dyspnea at rest Intensity of dyspnea after 50 meters of walking with pulse oximeter Oxygen saturation of arterial blood without oxygen therapy Arterial blood oxygen saturation with oxygen therapy

Notes
Last imported at : Nov. 13, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)

Phase
Last imported at : Nov. 13, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)

Not reported

Arms
Last imported at : Nov. 13, 2020, midnight
Source : Iranian Registry of Clinical Trials (IRCT)

[{"arm_notes": "", "treatment_id": 177, "treatment_name": "Balloon-blowing", "treatment_type": "Respiratory support", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]