Comparison of Standard and Endoscope Assisted Endotracheal Intubation

Not Applicable

• Conditions: Biliary Tract Diseases; Pancreatic Diseases

• Registration Number: NCT03879720
• Lead Sponsor: Stanford University

Brief Summary

Comparison of standard endotracheal intubation and endoscopist-facilitated endotracheal intubation

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 Timeline

• Study Start: 2018-08-30
• Study First Submitted: 2019-03-08
• Study First Submitted QC: 2019-03-14
• Study First Posted: 2019-03-19
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-06
• Last Update Posted: 2019-11-08
• Primary Completion: 2020-10
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Patients undergoing ERCP at Stanford University Medical Center

Exclusion Criteria

• Unable to consent
• Contra-indication to general anesthesia

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Time to Procedure Start	up to 1 hour	Time from patient entry into procedure room to insertion of endoscope/start of procedure

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Stanford University Medical Center; 🇺🇸 Stanford, California, United States