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

Randomized Nasal High Flow Therapy Versus Oxygen Supplementation in Postoperative Care of Obstructive Sleep Apnea Patients With Continuous Positive Airway Pressure Non-Compliance

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.

Study Overview

• Status: Completed
• Conditions: Obstructive Sleep Apnea
• Intervention / Treatment: Device: Low flow oxygen via nasal cannula; Device: Humidified Nasal High Flow Therapy

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 Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic in Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Device: Low flow oxygen via nasal cannula; In the low flow oxygen group, 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 saturation of oxygen of > 88%. Continuous oximetry will be collected up to 48 hours. Standard postsurgical care.
Active Comparator: 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.	Device: Humidified Nasal High Flow Therapy; Adjustment of initial setting upon floor arrival: To adjust oxygen 1-4 liters per minute to arterial saturation of oxygen > 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.; Other Names: Airvo 2 from Fisher and Paykel

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence rate of postoperative cardio-respiratory complications	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)	At 48 hours postsurgery

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Bernardo J. Selim, MD, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2015
• Primary Completion (Actual): May 28, 2017
• Study Completion (Actual): May 28, 2017

Study Registration Dates

• First Submitted: June 9, 2015
• First Submitted That Met QC Criteria: June 29, 2015
• First Posted (Estimate): June 30, 2015

Study Record Updates

• Last Update Posted (Actual): October 9, 2019
• Last Update Submitted That Met QC Criteria: October 7, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea
• Other Study ID Numbers: 15-000716

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No