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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

A

Ain Shams University

Status

Enrolling

Conditions

High Flow Nasal Cannula
Obstructive Sleep Apnea

Treatments

Other: High flow nasal cannula therapy group
Other: Conventional oxygen therapy group

Study type

Interventional

Funder types

Other

Identifiers

NCT06306651
FMASU MD283/2023

Details and patient eligibility

About

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.

Full 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 .

Enrollment

60 estimated patients

Sex

All

Ages

21 to 40 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

60 participants in 2 patient groups

High flow nasal cannula therapy group
Experimental group
Description:
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.
Treatment:
Other: High flow nasal cannula therapy group
Conventional oxygen therapy group
Active Comparator group
Description:
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.
Treatment:
Other: Conventional oxygen therapy group

Trial contacts and locations

1

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Central trial contact

Omar M Mohamed, Master

Data sourced from clinicaltrials.gov

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