Clinical trial NCT02485236: Postoperative Nasal High Flow Versus Oxygen for Positive Airway Pressure Non-Compliance Sleep Apnea Patients
Official title: Randomized Nasal High Flow Therapy Versus Oxygen Supplementation in Postoperative Care of Obstructive Sleep Apnea Patients With Continuous Positive Airway Pressure Non-Compliance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2015-06-30
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study aims to compare the efficacy of Nasal High Flow Therapy (NHF) with low-flow oxygen supplementation in improving postoperative intermittent desaturations. If so, this mode of therapy would provide a cost effective, relatively easy to implement, and better tolerated treatment to Continuous Positive Airway Pressure (CPAP) for oxygen stabilization.

Detailed description: Patients identified preoperatively with previously diagnosed obstructive sleep apnea (intermittent collapse of upper airway while asleep) who refuse Continuous Positive Airway Pressure use after surgery and are treated with routine postoperative supplemental oxygen alone (1 liters per minute) will have more oscillation of oxygen saturation during the night (measure by overnight oximetry) than those treated with high nasal flow air insufflator (Fisher \& Paykel Airvo 2 device) with same amount of oxygen supplement (1 liters per minute).

Eligibility criteria: Inclusion Criteria:

1. Known diagnosis of obstructive sleep apnea by polysomnography (Apnea Hypopnea Index ≥ 5 events per hour) with recommendation of Continuous Positive Airway Pressure use.
2. The patient declines use of Continuous Positive Airway Pressure for the upcoming elective surgery.
3. The patient will require more than 48 hours of hospitalization.
4. Informed consent obtained from patient or approved designate.

Exclusion Criteria:

1. Predetermined need for Continuous Positive Airway Pressure post-operatively by surgical team.
2. Body Mass Index ≥ 40.
3. Patient with congestive heart failure and diagnosis of Cheyne- Stokes respiration or central apnea.
4. Patients who are oxygen dependent due to moderate to severe Chronic Obstructive Pulmonary Disease (Available Forced Expiratory Volume at 1 second of \< 50% predicted) or advanced interstitial lung disease.
5. Preexisting chronic hypercapnia with known neuromuscular disease with respiratory involvement (e.g. Amyotrophic Lateral Sclerosis, myopathy).
6. Severe anemia necessitating blood transfusion.
7. Presence of tracheostomy.
8. Naso-oral malformation or severe nasal septal defect.
9. Presence of dementia or other diagnosed neurodegenerative disease.
10. Non-English speakers
11. Inability to provide informed consent.

Primary outcomes:
measure: The 4% change oxygen-desaturation index (4% ODI) determined by pulse oximetry
timeFrame: At 48 hours postsurgery
Secondary outcomes:
measure: Incidence rate of postoperative cardio-respiratory complications
timeFrame: At 48 hours postsurgery
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Bernardo J. Selim, MD
role: PRINCIPAL_INVESTIGATOR
References: