Early Application of Continuous Positive Airway Pressure in Coronavirus Patients at Risk of Obstructive Sleep Apnea

NCT05934916 | Completed

• 1 other identifier: MS.21.07.1578.
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

This was an experimental clinical trial, Aim: To evaluate the role of early use of Continuous Positive Airway Pressure (CPAP) in management of moderate to severe Coronavirus disease 2019 patients at risk of Obstructive Sleep Apnea, enrolled patients are randomized into two equal groups;Non- CPAP group and CPAP group. Non-CPAP group will receive medical treatment plus oxygen therapy according to recommendation of protocol of the Egyptian Ministry of Health 2020 and CPAP group as in Non-CPAP group plus using CPAP.

Conditions

Covid19; Obstructive Sleep Apnea; CPAP Ventilation; Corona Virus Infection

Keywords

( Coronavirus disease 2019); Coronavirus infections; sleep breathing disorder; obstructive sleep apnea

Outcome Measures

Primary Outcomes (1)

• Survival n (%), In hospital mortality , Duration of hospital stay, Need for invasive ventilation

  8 months

Study Arms (2)

Continuous Positive Airway Pressure (CPAP) group in (Coronavirus disease 2019) patients

EXPERIMENTAL

receive medical treatment plus oxygen therapy according to recommendation of protocol of the Egyptian Ministry of Health 2020 and using Continuous Positive Airway Pressure (CPAP)

Device: CPAP ( Continuous positive airway pressure); Device: oxygen therapy

Non-CPAP group

EXPERIMENTAL

Non-CPAP group will receive medical treatment plus oxygen therapy according to recommendation of protocol of the Egyptian Ministry of Health 2020

Device: oxygen therapy

Interventions

CPAP ( Continuous positive airway pressure) DEVICE

The enrolled eighty patients were simply randomized into two equal groups: Non-CPAP group and CPAP group using a computer-generated table of random numbers. The group allocation was concealed in sequentially numbered, sealed, and opaque envelopes. Patients were selected from isolation center in Mansoura University hospital,Non-CPAP group will receive medical treatment plus oxygen therapy according to recommendation of protocol of the Egyptian Ministry of Health 2020 and CPAP group as in Non-CPAP group plus using CPAP.

Continuous Positive Airway Pressure (CPAP) group in (Coronavirus disease 2019) patients

oxygen therapy DEVICE

both groups will receive oxygen

Continuous Positive Airway Pressure (CPAP) group in (Coronavirus disease 2019) patients; Non-CPAP group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients age above 18 years, diagnosed with moderate to severe (Coronavirus disease 2019) and at risk of Obstructive Sleep Apnea as well as confirmed nasopharyngeal swab positive for (Severe acute respiratory syndrome coronavirus 2) ( by (polymerase chain reaction).

You may not qualify if:

• patients were excluded from the study if their age \<18 years, hypercapnic, unstable cardiorespiratory (shock) status or respiratory arrest and if there are any contraindications for ( Continuous Positive Airway Pressure (CPAP) mask use

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura University

Al Mansurah, Al Dakahlia, Egypt, 35511, Egypt

Location

MeSH Terms

Conditions

COVID-19; Sleep Apnea, Obstructive; Coronavirus Infections

Interventions

Continuous Positive Airway Pressure; Oxygen Inhalation Therapy

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Sleep Apnea Syndromes; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Non-CPAP group will receive medical treatment plus oxygen therapy according to recommendation of protocol of the Egyptian Ministry of Health 2020 and CPAP group as in Non-CPAP group plus using CPAP.

Study Record Dates

• First Submitted: June 24, 2023
• First Posted: July 7, 2023
• Study Start: August 1, 2021
• Primary Completion: April 1, 2022
• Study Completion: April 1, 2022
• Last Updated: July 7, 2023

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

EG (1)