Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02850887
Other study ID # 201605151
Secondary ID
Status Completed
Phase N/A
First received July 21, 2016
Last updated February 2, 2018
Start date July 25, 2016
Est. completion date January 4, 2018

Study information

Verified date February 2018
Source Washington University School of Medicine
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of this study is to determine the effect of airway management (a set of medical procedures performed to prevent airway blockage and thus ensure an open path between a patient's lungs and the atmosphere) during endoscopic retrograde cholangiopancreatography [(ERCP), a procedure commonly used to treat conditions of the bile ducts and pancreas] and the effect on airway complications (problems), time to biliary cannulation (access into bile duct) and total procedure duration (length of time). Two methods are being compared and studied: 1) general endotracheal anesthesia: an inhalation anesthetic (substance that blocks pain) technique in which anesthetic and respiratory gases pass through a tube placed in the trachea (throat) via the mouth or nose vs 2) deep sedation without endotracheal intubation: local anesthesia together with sedation (drug that produces sleep) and analgesia (drug that treats pain) only.


Recruitment information / eligibility

Status Completed
Enrollment 200
Est. completion date January 4, 2018
Est. primary completion date November 29, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

1. Patient undergoing ERCP without preceding endoscopic ultrasound (EUS)

2. At least one of the following risk factors for adverse events during sedation:

1. STOP-BANG score of 3 or higher

2. Abdominal ascites on either physical exam or imaging within the last 14 days

3. BMI greater than or equal to 35

4. Chronic lung disease

5. ASA class 4

6. Mallampati Class 4 airway (only hard palate visible)

7. Concurrent moderate to heavy alcohol use (=4 drinks/day for men and =3 drinks/day for women)

Exclusion Criteria:

1. EUS preceding the ERCP

2. Emergent indication for ERCP (eg cholangitis with septic shock)

3. Presence of a tracheostomy

4. Unstable airway

5. Gastric outlet obstruction

6. Altered foregut anatomy (eg Roux-en-Y gastric bypass, Billroth II)

7. Inability to give informed consent

Study Design


Related Conditions & MeSH terms


Intervention

Other:
general endotracheal anesthesia
sedation with the use of endotracheal intubation
deep sedation without endotracheal intubation
deep sedation without endotracheal airway management.

Locations

Country Name City State
United States Washington University School of Medicine in St Louis Saint Louis Missouri

Sponsors (1)

Lead Sponsor Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of sedation related adverse events or the need for airway maneuvers approximately one year
Secondary Procedure duration intraoperative
Secondary Time to cannulation of intended duct system during the procedure
Secondary Technical success of ERCP approximately one year
Secondary Immediate ERCP adverse events Adverse events within 24 hours of ERCP
Secondary Delayed adverse events Adverse events occurring within 7 days
See also
  Status Clinical Trial Phase
Completed NCT03908411 - The Effect of Paratracheal Pressure on the Glottic View N/A
Completed NCT04564105 - Simulation Training and Teamwork Concerning Intubation on the Icu N/A
Completed NCT02988336 - TMHT - New Method of Difficult Intubation Prediction N/A
Completed NCT03002857 - Comparison of I-gel LMA, Classical LMA With a New Supraglottic Airway the Baska Mask® in Urological Surgery N/A
Recruiting NCT06337006 - Laryngeal Mask Airway Failure in Pediatric Patients
Completed NCT03443219 - RCT- LMA Supremeā„¢ Versus the Spritztube® Tracheal Cannula in Anesthetized Adult Patients N/A
Completed NCT05044416 - VieScope in Patients With an Expected Difficult Airway N/A
Not yet recruiting NCT05534451 - Comparison Among Three Different Video Scope Guided Nasotracheal Intubation. N/A
Recruiting NCT06073977 - Risk Factors for Pediatric Difficult Supraglottic Airway Placement and Ventilation
Not yet recruiting NCT03687385 - The Effect of High-flow Nasal Oxygenation to the Saturation During Analgo-sedation in Different ASA Risk Class Patients N/A
Not yet recruiting NCT03687424 - Can High-flow Nasal Oxygenation Improve Oxygen Saturation During Analgo-sedation in Obese Adults? N/A
Enrolling by invitation NCT05055401 - Airway Management Skills Amongst Anesthesia Providers
Not yet recruiting NCT02920879 - Airway Effects of PEEP During Anesthesia Induction. N/A
Terminated NCT02644837 - AuraGain and iGel Crossover Comparison N/A
Completed NCT02263300 - Spatial Orientation and Fiberoptic Intubation Skills in the Novice: A Randomized Controlled Trial
Completed NCT01718561 - The Difficult Airway Management Trial: "The DIFFICAIR-Trial" N/A
Completed NCT01635660 - Out-of-Hospital Randomized Comparison of Video-assisted Endotracheal Intubation N/A
Completed NCT00956592 - Clinical Evaluation of the Storz CMAC Laryngoscope N/A
Completed NCT00892671 - Airway Management and Vascular Access Simulation N/A
Completed NCT03848559 - Airway Management With Simulated Microgravity Using a Submerged Model N/A