NCT02166879

Brief Summary

The primary aim is to determine whether patients with suspected OSAHS as predicted by the STOP-BANG questionnaire will have an increased length of stay (LOS) in the postanesthesia acute care unit (PACU) compared with those without suspected OSAHS. The second aim will be to determine the LOS in patients with known sleep apnea by history. This length of stay will be compared with LOS in patient with an affirmative response to the STOP-BANG questionnaire to determine if prior knowledge of diagnosed sleep apnea will be associated with a lower LOS than in patients with suspected OSA. The third aim will be to characterize the adverse clinical outcomes (respiratory, cardiovascular, and neurological) associated with suspected OSAHS in patients who respond affirmatively to the STOP-BANG questionnaire and in those patients with known OSA. These data (including number of desaturations, bradypnea, brady- or tachycardia, and use of reversal agents) will be recorded by the PACU nursing staff. Unexpected admissions to the hospital and transfers to the intensive care units will also be measured. These data will help identify the most critical determinants of length of stay.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
900

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2011

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 2, 2011

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

June 13, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 18, 2014

Completed
6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2020

Completed
Last Updated

January 14, 2020

Status Verified

January 1, 2020

Enrollment Period

8.9 years

First QC Date

June 13, 2014

Last Update Submit

January 13, 2020

Conditions

Keywords

Obstructive Sleep Apnea-Hypopnea SyndromeObstructive sleep apneaOSAChart reviewQuestionnaireSurvey

Outcome Measures

Primary Outcomes (1)

  • Length of Stay (LOS) in the Postanesthesia Acute Care Unit (PACU)

    Length of stay in minutes as determined by the PACU nursing record documented. A difference in LOS of 15 minutes is considered to be clinically important. A 2-sample t-test used to compare OSAHS risk groups with respect to LOS.

    1 day

Study Arms (1)

Obstructive Sleep Apnea Hypopnea Syndrome (OSAHS)

Chart review from patients undergoing elective surgery.

Behavioral: Questionnaire

Interventions

QuestionnaireBEHAVIORAL

Participants complete anesthesia questionnaire before elective surgical procedure.

Also known as: Survey
Obstructive Sleep Apnea Hypopnea Syndrome (OSAHS)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Participants undergoing elective surgical procedures at UT MD Anderson Cancer Center in Houston, Texas

You may qualify if:

  • Patients assessed in the Anesthesia Assessment Center who are determined to require same day surgical procedures in the Ambulatory Care Center in the Mays Clinic.
  • Age ≥18

You may not qualify if:

  • \) Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Links

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Dave Balachandran, MD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dave Balachandran, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 13, 2014

First Posted

June 18, 2014

Study Start

September 2, 2011

Primary Completion

August 1, 2020

Study Completion

August 1, 2020

Last Updated

January 14, 2020

Record last verified: 2020-01

Locations