Obstructive Sleep Apnea and Bronchoscopy
Screening for Obstructive Sleep Apnea Predicts Cardiopulmonary Events in Patients Undergoing Bronchoscopy
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.
Studieoversigt
Status
Betingelser
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
-
-
-
Seoul, Korea, Republikken, 110744
- Seoul National University Hospital
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Cardiopulmonary events
Tidsramme: 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)
|
Any time during bronchoscopy under conscious sedation (procedure)
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Airway maneuvers
Tidsramme: Any time during bronchoscopy under conscious sedation (procedure)
|
Chin lift or Bag-mask ventilation or Unplanned endotracheal intubation
|
Any time during bronchoscopy under conscious sedation (procedure)
|
Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Jinwoo Lee, MD, Seoul National University
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 1612041813
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .