CPAP vs AutoCPAP for Treatment of Obstructive Sleep Apnea (OSA) in the Postoperative Setting

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2011-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to determine if an Autoadjusting CPAP machine is better than the regular CPAP machine in treatment of Obstructive Sleep Apnea in the postoperative setting.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Initiation of Auto-adjusting CPAP for Newly Diagnosed OSA in Hospitalized Patients

NCT01556464

Obstructive Sleep Apnea

WITHDRAWN NA

Modified AutoSet Device vs Existing AutoSet Device, the Assessment of Efficacy and Subjective Comfort of the Treatment.

NCT00906958

Sleep Apnea

COMPLETED NA

Improved Automatic CPAP Algorithm to Treat Obstructive Sleep Apnea (OSA)

NCT00850434

Obstructive Sleep Apnea (OSA)

COMPLETED NA

New Versus Existing Auto-titrating CPAP Device to Treat Obstructive Sleep Apnea in Adults

NCT01210261

Sleep Apnea, Obstructive

COMPLETED NA

The Effectiveness of Perioperative CPAP to Reduce Obstructive Sleep Apnea Related Adverse Events

NCT01249924

Obstructive Sleep Apnea (OSA)

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The purpose of this study is to determine if an Autoadjusting CPAP machine is better than the regular CPAP machine in treatment of Obstructive Sleep Apnea in the postoperative setting.

Patients with known Obstructive Sleep Apnea who are on CPAP therapy at home and undergo an elective surgery (meeting specified inclusion and exclusion criteria) will be randomized to either using Autoadjusting CPAP vs their usual CPAP at their prescribed settings the night after surgery. During that night, they will be monitored with full polysomnography in their hospital bed.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Obstructive Sleep Apnea

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Autoadjusting CPAP (VPAP auto)

The intervention will be the use of an Autoadjusting CPAP unit that will be applied to the subject during the 8 hours overnight the first night after surgery (study night). During this time, they will undergo a full night attended polysomnogram in their hospital room.

Group Type EXPERIMENTAL

Autoadjusting CPAP (VPAP Auto)

Intervention Type DEVICE

An autoadjusting CPAP unit is used in place of subject's own CPAP unit during the night of the polysomnography study (the first night after surgery).

CPAP arm (usual care)

The intervention will be the use of the subject's own CPAP machine and this will be applied to the subject during the 8 hours overnight the first after surgery (study night). During the study night, they will undergo full polysomnography in their hospital room.

Group Type ACTIVE_COMPARATOR

CPAP

Intervention Type DEVICE

Subject's own CPAP unit is applied to the subject during the polysomnography study night (the first night after surgery)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Autoadjusting CPAP (VPAP Auto)

An autoadjusting CPAP unit is used in place of subject's own CPAP unit during the night of the polysomnography study (the first night after surgery).

Intervention Type DEVICE

CPAP

Subject's own CPAP unit is applied to the subject during the polysomnography study night (the first night after surgery)

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

VPAP Auto

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Known OSA patients well-controlled by CPAP (not hypoxemic i.e. Oxygen Saturation (SaO2) ≥ 89% and post-treatment Apnea Hypopnea (AHI) \<10) and compliant ( \> 3 hours per night) presenting for elective inpatient surgery to MetroHealth Medical Center
2. Elective extremity or lower abdominal surgery
3. Age \>18 years

Exclusion Criteria

1. Surgery that may cause hypoxemia from causes other than the effect on upper airway patency e.g. any thoracic surgery, upper abdominal surgery, head and neck surgery.
2. Surgery on the upper-airway.
3. Any condition that may interfere with application of CPAP mask e.g. trauma, surgery on the face, vomiting, naso-gastric intubation etc.
4. OSA treated with a device other than CPAP e.g. Bilevel positive pressure or V-Positive Airway Pressure
5. OSA needing very high levels of CPAP i.e. \> 16 cms to achieve adequate control
6. OSA or other underlying cardiopulmonary conditions that require supplemental oxygen
7. Patients with decompensated congestive heart failure or advanced Chronic Obstructive Pulmonary Disease (COPD) (FEV1\<35% of predicted)
8. Patients with neuromuscular impairment
9. Patients with central sleep apnea
10. Pregnant patients
11. Decisional impaired subjects who are not able to consent

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No