Comparison of Standard and Endoscope Assisted Endotracheal Intubation

Comparison of Standard Endotracheal Intubation [SEI] and Endoscope Assisted Endotracheal Intubation [EAE]

Comparison of standard endotracheal intubation and endoscopist-facilitated endotracheal intubation

Study Overview

• Status: Unknown
• Conditions: Biliary Tract Diseases; Pancreatic Diseases
• Intervention / Treatment: Procedure: Endoscope assisted endotracheal intubation [EAEI]

Detailed Description

Endoscopic Retrograde Cholangiopancreatography (ERCP) procedures are typically performed using general anesthesia. During anesthesia, the anesthesiologist inserts a breathing tube (endotracheal tube) into the patient's wind pipe (trachea) and a machine helps the patient breathe (mechanical ventilation) while they are unconscious. The breathing tube is inserted with a patient laying on his/her back using a rigid metallic device (laryngoscope) to guide tube placement. The unconscious patient is then moved from the portable bed onto the X-ray table by nursing staff. The patient also has to be turned to lie on their stomach on the X-ray table for the procedure. This standard approach carries a small risk of patient injury during breathing tube placement as well as while moving and turning the unconscious patient onto the X-ray table.

At our endoscopy unit, endoscopists have, on several occasions, used a slim gastroscope to place the breathing tube under direct visualization in patients who are already positioned on their stomach for ERCP. This approach is rapid and has been uniformly successful and safe.

We hypothesize that this endoscopist-facilitated intubation approach may expedite the procedure and minimize ergonomic strain for staff during patient repositioning while minimizing patient injury during breathing tube placement and repositioning. This study seeks to formally compares the two approaches for placement of a breathing tube.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Subhas Banerjee; Phone Number: 650-723-2623; Email: sbanerje@stanford.edu

Study Locations

• United States
  • California
    • Stanford, California, United States, 94304
      • Recruiting
      • Stanford University Medical Center
      • Contact: Subhas Banerjee; Phone Number: 650-723-2623; Email: sbanerje@stanford.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients undergoing ERCP at Stanford University Medical Center

Exclusion Criteria:

• Unable to consent
• Contra-indication to general anesthesia

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard Endotracheal Intubation (SEI); the patient will be positioned supine on the gurney for intubation, with eventual position in the standard semi-prone ERCP position on the fluoroscopy table. Anesthesiologist-determined doses of Fentanyl, Versed, Propofol and Succinylcholine will be administered per standard of care and intubation will be accomplished by direct laryngoscopy or glidescope, with confirmation of endotracheal tube placement by auscultation.	Procedure: Endoscope assisted endotracheal intubation [EAEI]; Endoscope assisted endotracheal intubation [EAEI] performed by anesthesiologist with endoscopist assistance.; Other Names: Standard Endotracheal Intubation [SEI]
Experimental: Endoscope assisted endotracheal intubation [EAEI]; the patients will position themselves in the semi-prone position on the fluoroscopy table. Anesthesiologist-determined doses of Fentanyl, Versed and Propofol will be administered per standard of care. Succinylcholine will not be administered and therefore the patient will not be paralyzed. The endotracheal tube will be positioned on the mid-distal aspect of the ultra-slim endoscope and the ultra-slim endoscope will then be advanced into the trachea under direct endoscopic visualization to the level of the carina. The anesthesiologist will then advance the endotracheal tube over the endoscope into the trachea, and its position above the carina will be simultaneously confirmed endoscopically with the ultra-slim endoscope.	Procedure: Endoscope assisted endotracheal intubation [EAEI]; Endoscope assisted endotracheal intubation [EAEI] performed by anesthesiologist with endoscopist assistance.; Other Names: Standard Endotracheal Intubation [SEI]

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Procedure Start	Time from patient entry into procedure room to insertion of endoscope/start of procedure	up to 1 hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intubation Time (time from 'ready to intubate', to 'tube confirmation')	Endoscopy documentation	up to 1 hour
Patient positioning time	Recorded in endoscopy suite	up to 1 hour
Staff required for patient positioning	Recorded in endoscopy suite, # of staff	up to 20 minutes
Staff survey/assessment of ergonomic strain	Staff reporting of ergonomic strain encountered during the procedure scale of 1-5 to rate ergonomic strain,	up to 1 hour
Need for special positioning equipment	Documented based on procedure room observation, list of equipment	up to 20 minutes
Hypoxia (nadir O2 sat and duration), Arrhythmia, Hypotension	Evaluation of hypoxia during intubation	up to 20 minutes
Time from removal of GI endoscope to exit from procedure room	Documented in endoscopy suite	up to 60 minutes
Tooth/oropharyngeal trauma, skin/musculoskeletal trauma	Evaluation of oropharyngeal trauma and skin/musculoskeletal complaints following intubation, rating scale (0-5 to rate damage)	up to 24 hours post-procedure
Materials and facility fees	assessment of cost associated with procedures	up to 24 hours post-procedure

Collaborators and Investigators

• Sponsor: Stanford University

Study record dates

Study Major Dates

• Study Start (Actual): August 30, 2018
• Primary Completion (Anticipated): October 1, 2020
• Study Completion (Anticipated): December 1, 2020

Study Registration Dates

• First Submitted: March 8, 2019
• First Submitted That Met QC Criteria: March 14, 2019
• First Posted (Actual): March 19, 2019

Study Record Updates

• Last Update Posted (Actual): November 8, 2019
• Last Update Submitted That Met QC Criteria: November 6, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: ERCP; Anesthesia; Endoscopic Procedures
• Additional Relevant MeSH Terms: Digestive System Diseases; Pancreatic Diseases; Biliary Tract Diseases
• Other Study ID Numbers: 47089

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No