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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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06306651
Enrollment
60
Registered
2024-03-12
Start date
2024-03-16
Completion date
2025-03-01
Last updated
2024-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

High Flow Nasal Cannula, Obstructive Sleep Apnea

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 .

Interventions

OTHERHigh 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

OTHERConventional 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.

Sponsors

Ain Shams University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
21 Years to 40 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Oxygen desaturation indexDuring intensive care unit stay (assessed up to day 5)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%.

Secondary

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

Countries

Egypt

Contacts

Primary ContactOmar M Mohamed, Master
omarmedhat0100565@med.asu.edu.eg00201063190923

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026