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

Not Applicable

Completed

• Conditions: Obstructive Sleep Apnea
• Interventions: Device: Low flow oxygen via nasal cannula; Device: Humidified Nasal High Flow Therapy

• Registration Number: NCT02485236
• Lead Sponsor: Mayo Clinic

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).

Study Timeline

• Study Start: 2015-06
• Study First Submitted: 2015-06-09
• Study First Submitted QC: 2015-06-29
• Study First Posted: 2015-06-30
• Primary Completion: 2017-05-28
• Study Completion: 2017-05-28
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-07
• Last Update Posted: 2019-10-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low flow oxygen via nasal cannula	Low flow oxygen via nasal cannula	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.
Humidified Nasal High Flow Therapy	Humidified Nasal High Flow Therapy	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.

Primary Outcome Measures

Name	Time	Method
The 4% change oxygen-desaturation index (4% ODI) determined by pulse oximetry	At 48 hours postsurgery	The 4% change oxygen-desaturation index (4% ODI) as determined from the recorded pulse oximetry data during the first postoperative 48 hours.

Secondary Outcome Measures

Name	Time	Method
Incidence rate of postoperative cardio-respiratory complications	At 48 hours postsurgery	Incidence rate of postoperative cardio-respiratory complications such as Intensive Care Unit transfer, acute arrhythmia, myocardial ischemic event, delirium, new infiltrate or atelectasis, and any complication (combination of two or more of those above)

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States