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Obstructive Sleep Apnea and Bronchoscopy

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ClinicalTrials.gov Identifier: NCT03325153
Recruitment Status : Recruiting
First Posted : October 30, 2017
Last Update Posted : October 30, 2017
Sponsor:
Information provided by (Responsible Party):
Jinwoo Lee, Seoul National University Hospital

Brief Summary:

The prevalence of sleep-disordered breathing in Republic of Korea is 27% and 16% in men and women aged 40-69 years. Up to 93% of women and 82% of men with obstructive sleep apnea (OSA) remain undiagnosed. Polysomnography, the gold standard, is time consuming and costly. Patients with undiagnosed OSA may experience obstructive episodes during procedures with conscious sedation.

STOP-Bang questionnaire is the validated questionnaire to screen patients for undiagnosed OSA in the preoperative setting. It has high sensitivity (92.9%) for predicting patients with moderate to severe OSA.

Previous studies reported that STOP-Bang questionnaire predicted cardiopulmonary events during advanced endoscopic procedures such as endoscopic retrograde cholangiopancreatography (ERCP) and endoscopic ultrasound. However, there have been no studies regarding the risk for sedation-related cardiopulmonary events in patients with undiagnosed OSA undergoing bronchoscopy. Thus, we aimed to evaluate the prevalence of high-risk patients for OSA by a screening questionnaire, and to determine whether the questionnaire could predict patients who are at risk for cardiopulmonary events during bronchoscopy with conscious sedation.


Condition or disease
Obstructive Sleep Apnea of Adult

Study Type : Observational
Estimated Enrollment : 664 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Screening for Obstructive Sleep Apnea Predicts Cardiopulmonary Events in Patients Undergoing Bronchoscopy
Actual Study Start Date : December 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea
U.S. FDA Resources




Primary Outcome Measures :
  1. Cardiopulmonary events [ Time Frame: Any time during bronchoscopy under conscious sedation (procedure) ]
    Hypoxemia (SpO2 < 90%) or Hypotension (SBP < 90 mm Hg or a decrease of more than 25% from the baseline)


Secondary Outcome Measures :
  1. Airway maneuvers [ Time Frame: Any time during bronchoscopy under conscious sedation (procedure) ]
    Chin lift or Bag-mask ventilation or Unplanned endotracheal intubation



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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Tertiary referral hospital
Criteria

Inclusion Criteria:

  • Patients who are18 years or order undergoing bronchoscopy with conscious sedation in the bronchoscopy center

Exclusion Criteria:

  • Previous diagnosis of OSA
  • American Society of Anesthesiologists Physical Status Classification System score > 3
  • Baseline SpO2 < 90% or need for supplemental oxygen before the procedure
  • Tracheostomy tubes
  • An inability to provide informed consent
  • Undergoing the procedure based on an outpatient clinic
  • Undergoing BAL, EBUS-TBNA, and interventional bronchoscopy
  • Allergies or sensitivities to sedative medications
  • Pregnant

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03325153


Contacts
Contact: Jinwoo Lee, MD +82-2-2072-2228 realrain7@gmail.com

Locations
Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 110744
Contact: Jinwoo Lee, MD    82-2-2072-7593    realrain7@gmail.com   
Sponsors and Collaborators
Seoul National University Hospital
Investigators
Principal Investigator: Jinwoo Lee, MD Seoul National University

Responsible Party: Jinwoo Lee, Associate professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT03325153     History of Changes
Other Study ID Numbers: 1612041813
First Posted: October 30, 2017    Key Record Dates
Last Update Posted: October 30, 2017
Last Verified: October 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Jinwoo Lee, Seoul National University Hospital:
Obstructive Sleep Apnea
Bronchoscopy
STOP-Bang questionnaire
Cardiopulmonary events

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