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

• Sponsor: Mayo Clinic (Other)
• Overall Status: Completed
• CT.gov ID: NCT02485236
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Arms: 2
• Actual Duration (Months): 23.9
• Patients Per Site Per Month: 2.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Obstructive Sleep Apnea	Device: Low flow oxygen via nasal cannula; Device: Humidified Nasal High Flow Therapy	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Jun 1, 2015
• Actual Primary Completion Date: May 28, 2017
• Actual Study Completion Date: May 28, 2017

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

1. 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)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic in Rochester	Rochester	Minnesota	United States	55905

Sponsors and Collaborators

• Mayo Clinic

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Mayo Clinic Clinical Trials

Publications

None provided.

• Responsible Party: Bernardo J. Selim, M.D., PI, Mayo Clinic
• ClinicalTrials.gov Identifier: NCT02485236
• Other Study ID Numbers: 15-000716
• First Posted: Jun 30, 2015
• Last Update Posted: Oct 9, 2019
• Last Verified: Oct 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive

Study Results

No Results Posted as of Oct 9, 2019