Postoperative Nasal High Flow Versus Oxygen for Positive Airway Pressure Non-Compliance Sleep Apnea Patients
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 15-000716
NCT ID: NCT02485236
Sponsor Protocol Number: 15-000716
About this study
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.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential 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 ≥ 45.
- 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.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Bernardo Selim, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available