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Evaluation of Sleep Disordered Breathing Following Ambulatory Surgery

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by Walter Reed National Military Medical Center
Sponsor:
Collaborator:
Uniformed Services University of the Health Sciences
Information provided by (Responsible Party):
Arlene Hudson, Walter Reed National Military Medical Center
ClinicalTrials.gov Identifier:
NCT01851798
First received: May 8, 2013
Last updated: May 10, 2013
Last verified: May 2013
  Purpose

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.


Condition
Sleep Disordered Breathing

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Postoperative Home Sleep Test Changes in Ambulatory Surgical Patients With and Without Obstructive Sleep Apnea: A Prospective Clinical Trial

Resource links provided by NLM:


Further study details as provided by Walter Reed National Military Medical Center:

Primary Outcome Measures:
  • Unplanned hospital admission [ Time Frame: First three post operative days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Prevalence of OSA in orthopedic ambulatory surgical population [ Time Frame: Determined by home sleep test on night before surgery over study duration expected to be 2-3 years ] [ Designated as safety issue: No ]
    Prevalence of OSA in study population will be evaluated by preoperative home sleep test. The number of enrolled subject who have a home sleep test Apnea Hypopnea Index (AHI)=>5 will be considered positive. Prevalence will be determined by the percent of subjects who test positive of all those enrolled over the study period.


Other Outcome Measures:
  • Significant Change in Apnea-Hypopnea Index [ Time Frame: Night before surgery to the second post operative night ] [ Designated as safety issue: No ]

Estimated Enrollment: 600
Study Start Date: April 2013
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
ambulatory orthopedic surgery patients with OSA
ambulatory orthopedic surgery patients with home sleep test preoperative AHI => 5
ambulatory orthopedic surgery patients without OSA
ambulatory orthopedic surgery patients with home sleep test preoperative AHI < 5

Detailed Description:

Obstructive sleep apnea (OSA) is a highly prevalent syndrome of upper-airway obstruction and consequent cessation of respiration during sleep. Associated complications include impairment in the cardiovascular and cerebrovascular, neurological and endocrine systems. There is growing concern that the perioperative period may acutely worsen existing OSA or potentially induce sleep disordered breathing in susceptible individuals. Indeed, the presence of OSA has been shown to be an independent risk factor for perioperative complications. The mechanism for this perioperative risk, however, has yet to be fully elucidated.

This study proposes to investigate the relationship between surgical anesthesia and OSA with an observational prospective single-blinded investigation. A sample of 600 adult female and male orthopedic surgery patients scheduled for elective ambulatory orthopedic surgery at WRNMMC will be enrolled. Study subjects shall undergo an unattended Home Sleep Test (HST) the night before surgery followed by surgery and anesthesia as determined by the surgical team unchanged by study participation. Following the surgical procedure and anesthesia, the study subject will undergo a series of two additional HSTs on the first night following surgery and again on post-operative night three and complete a postoperative questionnaire including a validated screening questionnaire and information pertaining to postoperative pain and medication use.

Qualitative and quantitative analysis will be performed on the data. The prevalence in the ambulatory orthopedic population of screening positive with the STOP-BANG questionnaire, a validated Obstructive Sleep Apnea (OSA) screening tool, will be determined as well as the prevalence of OSA diagnosed by the preoperative Home Sleep Test (HST). The analysis of the HST data will be blinded as to OSA status, if known, and screening results using the validated "STOP-BANG" screening questionnaire. There are several additional research questions posed in this observational prospective single-blinded clinical study to determine if OSA, as defined by apnea-hypopnea index (AHI), is a significant factor in adverse events associated with ambulatory orthopedic surgery. First, a study sample size of 600 was selected to provide 82% power to detect a significant difference in unplanned admissions between patients with OSA (estimated at 20% of the surgical orthopedic population) and without OSA. This assumes 10% of patients without OSA experience unplanned admissions compared with 20% of patients with OSA. Other adverse perioperative events to be examined include difficult intubations, upper airway obstruction after extubation, bronchospasm, laryngospasm, arrhythmia such as atrial fibrillation, and need for mechanical ventilation

Additional questions to be examined include if surgery and anesthesia, the specific anesthetic technique, intraoperative sedative use, or postoperative sedative use is associated with any Home Sleep Test (HST) parameter (AHI, Oxygen Desaturation Index (ODI), pulse oximetry (SpO2) nadir, or percentage of time SpO2<90%). Paired t-tests will be used to perform the analyses except for the question of anesthetic technique for which analysis of variance followed by Tukey's post-hoc multiple comparisons will be employed.

Lastly is the clinically relevant question addressing whether there is a difference between patients who screen as high risk for OSA and those who screen as low risk for OSA with regard to pre and postoperative AHI, ODI, SpO2 nadir, or percentage of time SpO2<90%? High- and low-risk patients per the screening instrument will be compared using t-tests for independent samples.

Ultimately understanding the relationship between surgical anesthesia and OSA may be used to risk stratify patients, identify those at an increased risk for perioperative complications, or potentially aid in determining perioperative management plans.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01851798

Contacts
Contact: Arlene Hudson, MD 301-295-3140 arlene.hudson@usuhs.edu

Locations
United States, Maryland
Walter Reed National Military Medical Center Recruiting
Bethesda, Maryland, United States, 20889
Principal Investigator: Arlene Hudson, MD         
Sub-Investigator: Christopher Lettieri, MD         
Sponsors and Collaborators
Walter Reed National Military Medical Center
Uniformed Services University of the Health Sciences
Investigators
Principal Investigator: Arlene Hudson, MD Walter Reed National Military Medical Center and Uniformed Services University of the Health Sciences
  More Information

No publications provided

Responsible Party: Arlene Hudson, Assistant Professor of Anesthesiology, Walter Reed National Military Medical Center
ClinicalTrials.gov Identifier: NCT01851798     History of Changes
Other Study ID Numbers: WRNMMC IRB#384867
Study First Received: May 8, 2013
Last Updated: May 10, 2013
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by Walter Reed National Military Medical Center:
OSA
Sleep disordered breathing
anesthesia
ambulatory orthopedic surgery

Additional relevant MeSH terms:
Respiratory Aspiration
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Apnea
Sleep Disorders, Intrinsic
Sleep Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Dyssomnias
Nervous System Diseases

ClinicalTrials.gov processed this record on July 22, 2014