Postoperative Nasal High Flow Versus Oxygen for Positive Airway Pressure Non-Compliance Sleep Apnea Patients

Mayo Clinic

Status: Completed

Conditions: Obstructive Sleep Apnea

Treatments: Device: Low flow oxygen via nasal cannula; Device: Humidified Nasal High Flow Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT02485236

15-000716

Details and patient eligibility

About

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.

Full 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).

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups

Low flow oxygen via nasal cannula

Active Comparator group

Description:

In the low flow oxygen via nasal cannula, patients will be supplemented with 1 liter per minute via nasal cannula. Adjustment of initial setting upon floor arrival: To adjust oxygen 1-4 liters per minute to an arterial oxygen saturation of \> 88%. Continuous oximetry will be collected up to 48 hours. Standard postsurgical care.

Treatment:

Device: Low flow oxygen via nasal cannula

Humidified Nasal High Flow Therapy

Active Comparator group

Description:

Adjustment of humidified high flow air therapy: To adjust oxygen 1-4 liters per minute to an arterial oxygen saturation of \> 88%. To adjust air flow to patient comfort (20-35 liters per minute). Continuous oximetry will be collected up to 48 hours. Standard postsurgical care.

Treatment:

Device: Humidified Nasal High Flow Therapy