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

Primary Purpose

Obstructive Sleep Apnea

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Low flow oxygen via nasal cannula

Humidified Nasal High Flow Therapy

About this trial

This is an interventional treatment trial for Obstructive Sleep Apnea

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Mayo Clinic in Rochester

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Low flow oxygen via nasal cannula

Humidified Nasal High Flow Therapy

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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)

Full Information

NCT ID

NCT02485236

First Posted

June 9, 2015

Last Updated

October 7, 2019

Sponsor

Mayo Clinic

1. Study Identification

Unique Protocol Identification Number

NCT02485236

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2019

Overall Recruitment Status

Completed

Study Start Date

June 2015 (Actual)

Primary Completion Date

May 28, 2017 (Actual)

Study Completion Date

May 28, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Mayo Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obstructive Sleep Apnea

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

50 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Low flow oxygen via nasal cannula

Arm Type

Active Comparator

Arm Description

Arm Title

Humidified Nasal High Flow Therapy

Arm Type

Active Comparator

Arm Description

Intervention Type

Device

Intervention Name(s)

Low flow oxygen via nasal cannula

Intervention Description

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.

Intervention Type

Device

Intervention Name(s)

Humidified Nasal High Flow Therapy

Other Intervention Name(s)

Airvo 2 from Fisher and Paykel

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

At 48 hours postsurgery

Secondary Outcome Measure Information:

Title

Incidence rate of postoperative cardio-respiratory complications

Description

Time Frame

At 48 hours postsurgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bernardo J. Selim, MD

Organizational Affiliation

Mayo Clinic

Official's Role

Principal Investigator

Facility Information:

Facility Name

Mayo Clinic in Rochester

City

Rochester

State/Province

Minnesota

ZIP/Postal Code

55905

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Links:

URL

https://www.mayo.edu/research/clinical-trials

Description

Mayo Clinic Clinical Trials

Learn more about this trial

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

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