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

Obstructive Sleep Apnea Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02485236
• Other study ID #: 15-000716
• Status: Completed
• Phase: N/A
• Start date: June 2015
• Est. completion date: May 28, 2017

Study information

• Verified date: October 2019
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: May 28, 2017
• Est. primary completion date: May 28, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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

External Links

•   Mayo Clinic Clinical Trials