Clinical trial NCT03879720: Comparison of Standard and Endoscope Assisted Endotracheal Intubation
Official title: Comparison of Standard Endotracheal Intubation [SEI] and Endoscope Assisted Endotracheal Intubation [EAE]
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Biliary Tract Diseases
Pancreatic Diseases
Keywords: ERCP
Endoscopic Procedures
Anesthesia
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2019-03-19
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomization to standard endotracheal intubation or endoscopist-facilitated endotracheal intubation.
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing ERCP at Stanford University Medical Center

Exclusion Criteria:

* Unable to consent
* Contra-indication to general anesthesia

Primary outcomes:
measure: Time to Procedure Start
timeFrame: up to 1 hour
Secondary outcomes:
measure: Intubation Time (time from 'ready to intubate', to 'tube confirmation')
timeFrame: up to 1 hour
measure: Patient positioning time
timeFrame: up to 1 hour
measure: Staff required for patient positioning
timeFrame: up to 20 minutes
measure: Staff survey/assessment of ergonomic strain
timeFrame: up to 1 hour
measure: Need for special positioning equipment
timeFrame: up to 20 minutes
measure: Hypoxia (nadir O2 sat and duration), Arrhythmia, Hypotension
timeFrame: up to 20 minutes
measure: Time from removal of GI endoscope to exit from procedure room
timeFrame: up to 60 minutes
measure: Tooth/oropharyngeal trauma, skin/musculoskeletal trauma
timeFrame: up to 24 hours post-procedure
measure: Materials and facility fees
timeFrame: up to 24 hours post-procedure
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University Medical Center
state: California
Study officials:
References: