Sleep Apnea, ObstructiveNCT02166879
Undetected Sleep Apnea in the Postanesthesia Acute Care Unit (PACU)
An observational study of Sleep Apnea, Obstructive, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sleep Apnea, Obstructive
- What is being tested?
- Questionnaire
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 900 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Sep 2011to Aug 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants undergoing elective surgical procedures at UT MD Anderson Cancer Center in Houston, Texas
Who may be able to join
- 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
Who cannot join
- 1) Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: 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.
Read the 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.
- Conditions
- Sleep Apnea, Obstructive
- Being tested
- Questionnaire
- Keywords
- Obstructive Sleep Apnea-Hypopnea Syndrome, Obstructive sleep apnea, OSA, Chart review, Questionnaire, Survey
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireBehavioural
Also called Survey
Participants complete anesthesia questionnaire before elective surgical procedure.
| Study group | Role | What they receive |
|---|---|---|
| Obstructive Sleep Apnea Hypopnea Syndrome (OSAHS) | Chart review from patients undergoing elective surgery. Receives: Behavioral: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2014 (estimated)
- Study start2 Sep 2011
- Primary completionAug 2020 (estimated)
- Study completionAug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Apnea, ObstructiveStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 900 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dave Balachandran, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02166879
- Sponsor's protocol ID
- PA11-0591
- Status last verified
- Jan 2020
- First submitted
- 13 Jun 2014
- Last updated
- 14 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Undetected Sleep Apnea in the Postanesthesia Acute Care Unit
- ClinicalTrials.gov ID
- NCT02166879
- Acronym / sponsor ID
- PA11-0591
- Conditions
- Sleep Apnea, Obstructive
- Keywords
- Obstructive Sleep Apnea-Hypopnea Syndrome, Obstructive sleep apnea, OSA, Chart review, Questionnaire, Survey
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 900 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 2 Sep 2011 (actual)
- Primary completion
- Aug 2020 (estimated)
- Study completion
- Aug 2020 (estimated)
- First posted
- 18 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Obstructive Sleep Apnea Hypopnea Syndrome (OSAHS) | – | Behavioral: QuestionnaireChart review from patients undergoing elective surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants undergoing elective surgical procedures at UT MD Anderson Cancer Center in Houston, Texas
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- 1) Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnaireAlso: SurveyParticipants complete anesthesia questionnaire before elective surgical procedure. | Behavioural | Obstructive Sleep Apnea Hypopnea Syndrome (OSAHS) |
Primary outcome
Length of Stay (LOS) in the Postanesthesia Acute Care Unit (PACU)
Time frame: 1 day
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2020.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dave Balachandran, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sleep Apnea, Obstructive, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dave Balachandran, MD (713-792-6238, DBalachandran@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of Stay (LOS) in the Postanesthesia Acute Care Unit (PACU) (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2020.