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Completed

NCT Number: NCT02485236

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

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.

Other names: Airvo 2 from Fisher and Paykel

Primary outcomes

  1. The 4% change oxygen-desaturation index (4% ODI) determined by pulse oximetry

    Time frame: 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 outcomes

  1. Incidence rate of postoperative cardio-respiratory complications

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Jun 30, 2015
Registry last updated
Oct 9, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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