High Flow Nasal Cannula and Conventional Oxygen Therapy in the Postoperative Management of Patients With Mild to Moderate Obstructive Sleep Apnea

NCT06306651 | Recruiting

• 1 other identifier: FMASU MD283/2023
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to compare the effectiveness of conventional oxygen therapy oxygen and high-flow nasal cannula therapy on oxygen saturation (SpO2), measuring number of SpO2 drop \>4% of base line oxygen saturation (o2 desaturation index), length of the ICU stay, and the need of use supplemental continuous positive airway pressure (CPAP) support in any of the study groups in the postoperative ICU setting.

Conditions

High Flow Nasal Cannula; Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (1)

• Oxygen desaturation index

  Oxygen desaturation index will be recorded through by pulse oximeter, while respiratory rate will be recorded by the ECG monitoring and visual count hourly. The number of recorded drops in baseline SpO2 of \>4%.

  During intensive care unit stay (assessed up to day 5)

Secondary Outcomes (2)

• The length of Intensive care unit stay

  At the time of intensive care unit discharge (up to day 5)

• The incidence of ventilatory support

  At the time of intensive care unit discharge (up to day 5)

Study Arms (2)

High flow nasal cannula therapy group

EXPERIMENTAL

Patients who will be randomized to high flow nasal cannula therapy. High flow nasal oxygen cannula will be applied at a flow of 20 L/min at FiO2 of 0.4 at a temperature of 36oC.

Other: High flow nasal cannula therapy group

Conventional oxygen therapy group

ACTIVE COMPARATOR

Patients who will be randomized to simple oxygen mask therapy. The simple face mask will be applied in a rate range between 6-10 L/min.

Other: Conventional oxygen therapy group

Interventions

High flow nasal cannula therapy group OTHER

Patients who will be randomized to high flow nasal cannula therapy. High flow nasal oxygen cannula will be applied at a flow of 20 L/min at FiO2 of 0.4 at a temperature of 36oC

High flow nasal cannula therapy group

Conventional oxygen therapy group OTHER

Patients who will be randomized to simple oxygen mask therapy. The simple face mask will be applied in a rate range between 6-10 L/min.

Conventional oxygen therapy group

Eligibility Criteria

• Age: 21 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age group from 21 - 40 years old.
• Both sexes.
• Mild to moderate obstructive sleep apnea (OSA) patients with STOP-BANG score less than 5.
• OSA patients undergoing non cardiac surgeries.
• Patients who will undergo scheduled elective surgeries under general anesthesia.

You may not qualify if:

• Patient refusal of procedure or participation in the study.
• Patients with severe OSA, STOP-BANG score more than or equal 5.
• Patients dependent on home ventilation CPAP or bilevel devices.
• Pregnant females.
• Post cardiac or thoracic surgery patients.
• More than American Society of Anesthesiologists (ASA) II patients.
• Head and face trauma patients.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University

Cairo, 11591, Egypt

RECRUITING

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Central Study Contacts

Omar M Mohamed, Master

CONTACT

00201063190923; omarmedhat0100565@med.asu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Ain Shams University, Cairo, Egypt.

Study Record Dates

• First Submitted: March 3, 2024
• First Posted: March 12, 2024
• Study Start: March 16, 2024
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2025
• Last Updated: March 19, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)