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

NCT02485236 | Completed

• 1 other identifier: 15-000716
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Incidence rate of postoperative cardio-respiratory complications

  At 48 hours postsurgery

Study Arms (2)

Low flow oxygen via nasal cannula

ACTIVE COMPARATOR

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

Humidified Nasal High Flow Therapy

ACTIVE COMPARATOR

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

Interventions

Low flow oxygen via nasal cannula DEVICE

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.

Low flow oxygen via nasal cannula

Humidified Nasal High Flow Therapy DEVICE

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.

Also known as: Airvo 2 from Fisher and Paykel

Humidified Nasal High Flow Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Predetermined need for Continuous Positive Airway Pressure post-operatively by surgical team.
• Body Mass Index ≥ 40.
• Patient with congestive heart failure and diagnosis of Cheyne- Stokes respiration or central apnea.
• 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.
• Preexisting chronic hypercapnia with known neuromuscular disease with respiratory involvement (e.g. Amyotrophic Lateral Sclerosis, myopathy).
• Severe anemia necessitating blood transfusion.
• Presence of tracheostomy.
• Naso-oral malformation or severe nasal septal defect.
• Presence of dementia or other diagnosed neurodegenerative disease.
• Non-English speakers
• Inability to provide informed consent.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Bernardo J. Selim, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: June 9, 2015
• First Posted: June 30, 2015
• Study Start: June 1, 2015
• Primary Completion: May 28, 2017
• Study Completion: May 28, 2017
• Last Updated: October 9, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)