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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Obstructive Sleep Apnea; High Flow Nasal Cannula
• Intervention / Treatment: Other: High flow nasal cannula therapy group; Other: Conventional oxygen therapy group

Detailed Description

In the surgical setting, patients with obstructive sleep apnea (OSA) may have increased upper airway collapsibility affecting ventilation and increased sensitivity to sedation from anesthetics and opioids.

Surgical patients with OSA have a high risk for postoperative complications, including cardiac events, hypoxemia, and transfer to the intensive care unit . Continuous positive airway pressure (CPAP) is the gold standard treatment for moderate to severe OSA , and effectively reduces the risk of cardiovascular events. Evidence has shown that CPAP effectively reduces length of ICU stay (LOS) in the postoperative setting. In these scenarios, conventional oxygen therapy and high-flow nasal cannula (HFNC) therapy have been used as an alternative for CPAP non-adherent patients.

HFNC delivers warm, humidified air through a nasal cannula at high flow rates of up to 60 L/min. This high flow rate may increase end-expiratory pharyngeal pressure up to 3 cm H2O, decreasing the force required to alleviate airway collapse . Using a nasal cannula interface in contrast to the CPAP mask may provide a more comfortable experience for patients during sleep .

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Omar M Mohamed, Master; Phone Number: 00201063190923; Email: omarmedhat0100565@med.asu.edu.eg

Study Locations

• Egypt
  • Cairo, Egypt, 11591
    • Recruiting
    • ain shams University
    • Contact: Omar M Mohamed, Master; Phone Number: 00201063190923; Email: omarmedhat0100565@med.asu.edu.eg
    • Sub-Investigator: Bahaa A Ali, MD
    • Sub-Investigator: Adel M Alansary, MD
    • Sub-Investigator: Nora M Mahmoud, MD
    • Sub-Investigator: Mohamed M Abdallah, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: High flow nasal cannula therapy group; 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; 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
Active Comparator: Conventional oxygen therapy group; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
The length of Intensive care unit stay	The length of Intensive care unit stay will be measured from the start of surgery until the discharge.	At the time of intensive care unit discharge (up to day 5)
The incidence of ventilatory support	The incidence of ventilatory support is either non-invasive ventilation (NIV) and continuous positive airway pressure (CPAP) or intubation and mechanical ventilation.	At the time of intensive care unit discharge (up to day 5)

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): March 16, 2024
• Primary Completion (Estimated): March 1, 2025
• Study Completion (Estimated): March 1, 2025

Study Registration Dates

• First Submitted: March 3, 2024
• First Submitted That Met QC Criteria: March 10, 2024
• First Posted (Actual): March 12, 2024

Study Record Updates

• Last Update Posted (Actual): March 19, 2024
• Last Update Submitted That Met QC Criteria: March 16, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea
• Other Study ID Numbers: FMASU MD283/2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
• IPD Sharing Time Frame: After the end of study for one year.
• IPD Sharing Access Criteria: The data will be available upon a reasonable request from the corresponding author.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No