Clinical trial NCT06306651: High Flow Nasal Cannula and Conventional Oxygen Therapy in the Postoperative Management of Patients With Mild to Moderate Obstructive Sleep Apnea
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: High Flow Nasal Cannula
Obstructive Sleep Apnea
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2024-03-12
Enrollment: 60
Sex: ALL
Minimum age (years): 21
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 .

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.

Primary outcomes:
measure: Oxygen desaturation index
timeFrame: During intensive care unit stay (assessed up to day 5)
Secondary outcomes:
measure: The length of Intensive care unit stay
timeFrame: At the time of intensive care unit discharge (up to day 5)
measure: The incidence of ventilatory support
timeFrame: At the time of intensive care unit discharge (up to day 5)
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University
Study officials:
References: