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

NCT ID: NCT06306651

Last Updated: 2024-03-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-16
• Study Completion Date: 2025-03-01

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.

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 .

Conditions

High Flow Nasal Cannula; Obstructive Sleep Apnea

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

High flow nasal cannula therapy group

Intervention Type: 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

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.

Group Type: ACTIVE_COMPARATOR

Conventional oxygen therapy group

Intervention Type: 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.

Interventions

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

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Omar medhat

Assistant Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Ain Shams University, Cairo, Egypt.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ain Shams University

Cairo, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Omar M Mohamed, Master

Role: CONTACT

omarmedhat0100565@med.asu.edu.eg

00201063190923

Facility Contacts

Omar M Mohamed, Master

Role: primary

omarmedhat0100565@med.asu.edu.eg

00201063190923

Other Identifiers

FMASU MD283/2023

Identifier Type: -

Identifier Source: org_study_id