Comparison of Standard and Endoscope Assisted Endotracheal Intubation

Pancreatic Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03879720
• Other study ID #: 47089
• Status: Recruiting
• Phase: N/A
• Start date: August 30, 2018
• Est. completion date: December 2020

Study information

• Verified date: November 2019
• Source: Stanford University
• Contact: Subhas Banerjee
• Phone: 650-723-2623
• Email: sbanerje[@]stanford.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Comparison of standard endotracheal intubation and endoscopist-facilitated endotracheal intubation

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2020
• Est. primary completion date: October 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients undergoing ERCP at Stanford University Medical Center

Exclusion Criteria:

• Unable to consent

• Contra-indication to general anesthesia

Related Conditions & MeSH terms

• Biliary Tract Diseases
• Pancreatic Diseases

Intervention

Procedure:
• Endoscope assisted endotracheal intubation [EAEI]
Endoscope assisted endotracheal intubation [EAEI] performed by anesthesiologist with endoscopist assistance.

Locations

Country	Name	City	State
United States	Stanford University Medical Center	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to Procedure Start	Time from patient entry into procedure room to insertion of endoscope/start of procedure	up to 1 hour
Secondary	Intubation Time (time from 'ready to intubate', to 'tube confirmation')	Endoscopy documentation	up to 1 hour
Secondary	Patient positioning time	Recorded in endoscopy suite	up to 1 hour
Secondary	Staff required for patient positioning	Recorded in endoscopy suite, # of staff	up to 20 minutes
Secondary	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
Secondary	Need for special positioning equipment	Documented based on procedure room observation, list of equipment	up to 20 minutes
Secondary	Hypoxia (nadir O2 sat and duration), Arrhythmia, Hypotension	Evaluation of hypoxia during intubation	up to 20 minutes
Secondary	Time from removal of GI endoscope to exit from procedure room	Documented in endoscopy suite	up to 60 minutes
Secondary	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
Secondary	Materials and facility fees	assessment of cost associated with procedures	up to 24 hours post-procedure