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Comparison of Standard and Endoscope Assisted Endotracheal Intubation

Not Applicable
Conditions
Biliary Tract Diseases
Pancreatic Diseases
Interventions
Procedure: Endoscope assisted endotracheal intubation [EAEI]
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.

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
100
Inclusion Criteria
  • Patients undergoing ERCP at Stanford University Medical Center
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Exclusion Criteria
  • Unable to consent
  • Contra-indication to general anesthesia
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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Standard Endotracheal Intubation (SEI)Endoscope assisted endotracheal intubation [EAEI]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.
Endoscope assisted endotracheal intubation [EAEI]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.
Primary Outcome Measures
NameTimeMethod
Time to Procedure Startup to 1 hour

Time from patient entry into procedure room to insertion of endoscope/start of procedure

Secondary Outcome Measures
NameTimeMethod
Intubation Time (time from 'ready to intubate', to 'tube confirmation')up to 1 hour

Endoscopy documentation

Materials and facility feesup to 24 hours post-procedure

assessment of cost associated with procedures

Hypoxia (nadir O2 sat and duration), Arrhythmia, Hypotensionup to 20 minutes

Evaluation of hypoxia during intubation

Time from removal of GI endoscope to exit from procedure roomup to 60 minutes

Documented in endoscopy suite

Tooth/oropharyngeal trauma, skin/musculoskeletal traumaup to 24 hours post-procedure

Evaluation of oropharyngeal trauma and skin/musculoskeletal complaints following intubation, rating scale (0-5 to rate damage)

Patient positioning timeup to 1 hour

Recorded in endoscopy suite

Need for special positioning equipmentup to 20 minutes

Documented based on procedure room observation, list of equipment

Staff required for patient positioningup to 20 minutes

Recorded in endoscopy suite, # of staff

Staff survey/assessment of ergonomic strainup 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

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Stanford, California, United States

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