Undetected Sleep Apnea in the Postanesthesia Acute Care Unit (PACU)

Undetected Sleep Apnea in the Postanesthesia Acute Care Unit

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.

Study Overview

• Status: Unknown
• Conditions: Sleep Apnea, Obstructive
• Intervention / Treatment: Behavioral: Questionnaire

Detailed Description

The study will retrospectively review the anesthetic record, including both the preoperative assessment records and the PACU flow sheets. The study will be conducted in the Anesthesiology Assessment Center. PACU. The STOP-BANG questionnaire is administered as part of the standard of care during the preoperative assessment.

Anesthesia Assessment Center clinics assess approximately 500 patients a week, of which approximately 25% are scheduled for ambulatory surgical procedures in the Mays clinic.

Patients are administered the STOP-BANG questionnaire as part of the standard of care while in the perioperative center. This will be recorded on the Initial Anesthesia Assessment Center Patient Record. This form is filled out by hand by the patients themselves and then scanned into Clinic Station. The neck circumference portion of the Bang questionnaire is assessed and recorded by the medical assistant with the use of a single use disposable paper tape measure. The data are recorded along with basic demographic, historical, and anthropometric data (including BMI) in a preoperative assessment record.

In order to satisfy the first specific aim, length of stay in minutes as determined by the PACU nursing record will be documented. Nurses charting the LOS will not be specifically made aware of the STOP-BANG status of the subjects. Length of stay is charted in the PACU nursing forms electronically in PICIS and relayed to Clinic Station as part of the standard of care for all patients admitted to the PACU.

In order to satisfy the third specific aim, patients enrolled in the study will be monitored for secondary outcomes via chart review of the PACU nursing record and electronic medical record. These outcomes are charted in the PACU nursing forms electronically in PCIS and relayed to Clinic Station as standard of care in all patients in the PACU.

• Study Type: Observational
• Enrollment (Anticipated): 900

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • University of Texas MD Anderson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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

Description

Inclusion Criteria:

1. 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.
2. Age ≥18

Exclusion Criteria:

1) Pregnancy

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Obstructive Sleep Apnea Hypopnea Syndrome (OSAHS); Chart review from patients undergoing elective surgery.	Behavioral: Questionnaire; Participants complete anesthesia questionnaire before elective surgical procedure.; Other Names: Survey

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: M.D. Anderson Cancer Center
• Investigators: Principal Investigator: Dave Balachandran, MD, M.D. Anderson Cancer Center

Publications and helpful links

Helpful Links

• University of Texas MD Anderson Cancer Center Website

Study record dates

Study Major Dates

• Study Start (Actual): September 2, 2011
• Primary Completion (Anticipated): August 1, 2020
• Study Completion (Anticipated): August 1, 2020

Study Registration Dates

• First Submitted: June 13, 2014
• First Submitted That Met QC Criteria: June 16, 2014
• First Posted (Estimate): June 18, 2014

Study Record Updates

• Last Update Posted (Actual): January 14, 2020
• Last Update Submitted That Met QC Criteria: January 13, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: Obstructive sleep apnea; OSA; Questionnaire; Survey; Obstructive Sleep Apnea-Hypopnea Syndrome; Chart review
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea
• Other Study ID Numbers: PA11-0591

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No