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

Mansoura University

Status: Completed

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

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

Study type: Interventional

Funder types: Other

Identifiers

NCT05934916

MS.21.07.1578.

Details and patient eligibility

About

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.

Full description

steps included

1. Clinical Assessment:

   Full history taking were taken from the enrolled Coronavirus disease 2019patients including age, occupation, medical history and special habits), Coronavirus disease 2019 symptoms (e.g., fever, dyspnea, fatigue, loss of smell or taste, (gastrointestinal tract) symptoms....) as well as all obstructive sleep apnea symptoms (e.g., Snoring, Insomnia, Excessive day time sleepiness, witnessed apnea, ...).

2. II. Scales & Questionnaires:

   • Epworth Sleepiness Scale (ESS) It's designed to assess the degree of daytime sleepiness.
   • • Berlin Questionnaire
   • • (Snoring, Tiredness, observed apnea, high blood pressure, body mass Index, age, neck circumference and male Gender questionnaire: This scoring system composed of 8 items that are graded from 0 to 8 according to Yes/No responses (score: 1/0).

3. III. Radiological investigations

4. IV. Laboratory Investigations Blood gases, complete blood picture, etc

5. . CPAP application Auto-CPAP with continuous nocturnal administration or at least4- 6hours /night and during day naps, for more than 70% of nights from the first night of admission to isolation center

Enrollment: 80 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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).

Exclusion criteria

• 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups

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

Experimental group

Description:

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)

Treatment:

Device: oxygen therapy

Device: CPAP ( Continuous positive airway pressure)

Non-CPAP group

Experimental group

Description:

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

Treatment:

Device: oxygen therapy