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

Obstructive Sleep Apnea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06306651
• Other study ID #: FMASU MD283/2023
• Status: Recruiting
• Phase: N/A
• Start date: March 16, 2024
• Est. completion date: March 1, 2025

Study information

• Verified date: March 2024
• Source: Ain Shams University
• Contact: Omar M Mohamed, Master
• Phone: 00201063190923
• Email: omarmedhat0100565[@]med.asu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 .

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: March 1, 2025
• Est. primary completion date: March 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Apnea
• High Flow Nasal Cannula
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

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
• 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.

Locations

Country	Name	City	State
Egypt	Ain Shams University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)