Evaluation of Sleep Disordered Breathing Following Ambulatory Surgery

NCT01851798 | Terminated DMC

• 1 other identifier: WRNMMC IRB#384867
• Study Type: observational
• Target: 203
• Locations: 1 country
• Sites: 1

Brief Summary

Obstructive sleep apnea (OSA) is a relatively common medical condition that includes upper-airway obstruction and consequent cessation of breathing during sleep with significant associated other medical problems. The time period around surgery has been demonstrated to be an independent risk factor for various complications but the mechanism is not well understood. This protocol proposes to study the fundamental question of what changes occur in the postoperative setting to ambulatory patients with and without OSA by administering a validated "STOP-BANG" screening questionnaire and conducting preoperative and postoperative Home Sleep Testing (HST). In doing so, critical evidence shall be gained in the understanding of postoperative sleep disorder breathing changes associated with surgery and anesthesia. With evidence, sound perioperative management recommendations and policy may be developed to assist with caring for this large and at risk surgical population.

Conditions

Sleep Disordered Breathing

Keywords

OSA; Sleep disordered breathing; anesthesia; ambulatory orthopedic surgery

Outcome Measures

Primary Outcomes (1)

• Unplanned hospital admission

  First three post operative days

Secondary Outcomes (1)

• Prevalence of OSA in orthopedic ambulatory surgical population

  Determined by home sleep test on night before surgery over study duration expected to be 2-3 years

Other Outcomes (1)

• Significant Change in Apnea-Hypopnea Index

  Night before surgery to the second post operative night

Study Arms (2)

ambulatory orthopedic surgery patients with OSA

ambulatory orthopedic surgery patients with home sleep test preoperative AHI =\> 5

Other: Home sleep test administered to all enrolled subjects

ambulatory orthopedic surgery patients without OSA

ambulatory orthopedic surgery patients with home sleep test preoperative AHI \< 5

Other: Home sleep test administered to all enrolled subjects

Interventions

Home sleep test administered to all enrolled subjects OTHER

ambulatory orthopedic surgery patients with OSA; ambulatory orthopedic surgery patients without OSA

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

ambulatory orthopedic surgery patients presenting to Walter Reed National Military Medical Center

You may qualify if:

• Male and female military health care beneficiaries between the ages of 18 and 85 years presenting for elective ambulatory orthopedic surgery at WRNMMC main operating room.
• American Society of Anesthesiologist physical classification (ASA) I-II
• Scheduled for elective ambulatory orthopedic surgery
• Patients English speaking and capable of providing informed consent.

You may not qualify if:

• Patients who are pregnant or breast-feeding at the time of the procedure. Pregnancy will be ruled out by day of surgery urine human chorionic gonadotropin (HCG) when appropriate.
• Chronic opioid, benzodiazepine, pregabalin, or other sedating medication users
• Chronic alcohol users (defined by daily or greater use upon standard anesthesia preoperative interview)
• Patients who require home oxygen use
• Patients who have a tracheostomy
• Patients who decline to participate.

Sponsors & Collaborators

• Walter Reed National Military Medical Center: lead
• Uniformed Services University of the Health Sciences: collaborator

Study Sites (1)

Walter Reed National Military Medical Center

Bethesda, Maryland, 20889, United States

Location

Related Publications (1)

• Hudson AJ, Walter RJ, Flynn J, Szpisjak DF, Olsen C, Rodgers M, Capaldi VF 2nd, McDuffie B, Lettieri CJ. Ambulatory Surgery Has Minimal Impact on Sleep Parameters: A Prospective Observational Trial. J Clin Sleep Med. 2018 Apr 15;14(4):593-602. doi: 10.5664/jcsm.7052.

  PMID: 29609705 DERIVED

MeSH Terms

Conditions

Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Arlene Hudson, MD

  Walter Reed National Military Medical Center and Uniformed Services University of the Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Anesthesiology

Study Record Dates

• First Submitted: May 8, 2013
• First Posted: May 10, 2013
• Study Start: April 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: December 15, 2015

Record last verified: 2015-12

Locations

US (1)