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Comparison of Standard and Endoscope Assisted Endotracheal Intubation

Primary Purpose

Biliary Tract Diseases, Pancreatic Diseases

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Endoscope assisted endotracheal intubation [EAEI]
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Biliary Tract Diseases focused on measuring ERCP, Endoscopic Procedures, Anesthesia

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients undergoing ERCP at Stanford University Medical Center

Exclusion Criteria:

  • Unable to consent
  • Contra-indication to general anesthesia

Sites / Locations

  • Stanford University Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard Endotracheal Intubation (SEI)

Endoscope assisted endotracheal intubation [EAEI]

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
March 8, 2019
Last Updated
November 6, 2019
Sponsor
Stanford University
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1. Study Identification

Unique Protocol Identification Number
NCT03879720
Brief Title
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

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Unknown status
Study Start Date
August 30, 2018 (Actual)
Primary Completion Date
October 2020 (Anticipated)
Study Completion Date
December 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Biliary Tract Diseases, Pancreatic Diseases
Keywords
ERCP, Endoscopic Procedures, Anesthesia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomization to standard endotracheal intubation or endoscopist-facilitated endotracheal intubation.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard Endotracheal Intubation (SEI)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Endoscope assisted endotracheal intubation [EAEI]
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Endoscope assisted endotracheal intubation [EAEI]
Other Intervention Name(s)
Standard Endotracheal Intubation [SEI]
Intervention Description
Endoscope assisted endotracheal intubation [EAEI] performed by anesthesiologist with endoscopist assistance.
Primary Outcome Measure Information:
Title
Time to Procedure Start
Description
Time from patient entry into procedure room to insertion of endoscope/start of procedure
Time Frame
up to 1 hour
Secondary Outcome Measure Information:
Title
Intubation Time (time from 'ready to intubate', to 'tube confirmation')
Description
Endoscopy documentation
Time Frame
up to 1 hour
Title
Patient positioning time
Description
Recorded in endoscopy suite
Time Frame
up to 1 hour
Title
Staff required for patient positioning
Description
Recorded in endoscopy suite, # of staff
Time Frame
up to 20 minutes
Title
Staff survey/assessment of ergonomic strain
Description
Staff reporting of ergonomic strain encountered during the procedure scale of 1-5 to rate ergonomic strain,
Time Frame
up to 1 hour
Title
Need for special positioning equipment
Description
Documented based on procedure room observation, list of equipment
Time Frame
up to 20 minutes
Title
Hypoxia (nadir O2 sat and duration), Arrhythmia, Hypotension
Description
Evaluation of hypoxia during intubation
Time Frame
up to 20 minutes
Title
Time from removal of GI endoscope to exit from procedure room
Description
Documented in endoscopy suite
Time Frame
up to 60 minutes
Title
Tooth/oropharyngeal trauma, skin/musculoskeletal trauma
Description
Evaluation of oropharyngeal trauma and skin/musculoskeletal complaints following intubation, rating scale (0-5 to rate damage)
Time Frame
up to 24 hours post-procedure
Title
Materials and facility fees
Description
assessment of cost associated with procedures
Time Frame
up to 24 hours post-procedure

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients undergoing ERCP at Stanford University Medical Center Exclusion Criteria: Unable to consent Contra-indication to general anesthesia
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Subhas Banerjee
Phone
650-723-2623
Email
sbanerje@stanford.edu
Facility Information:
Facility Name
Stanford University Medical Center
City
Stanford
State/Province
California
ZIP/Postal Code
94304
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Subhas Banerjee
Phone
650-723-2623
Email
sbanerje@stanford.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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Comparison of Standard and Endoscope Assisted Endotracheal Intubation

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