Biliary Tract DiseasesNCT03879720
Comparison of Standard and Endoscope Assisted Endotracheal Intubation
A study testing Endoscope assisted endotracheal intubation [EAEI] in people with Biliary Tract Diseases and Pancreatic Diseases, run by Stanford University at 1 site in United States.
Trial summary
Comparison of standard endotracheal intubation and endoscopist-facilitated endotracheal intubation Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Biliary Tract Diseases, Pancreatic Diseases
- What is being tested?
- Endoscope assisted endotracheal intubation [EAEI]
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Aug 2018to Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients undergoing ERCP at Stanford University Medical Center
Who cannot join
- Unable to consent
- Contra-indication to general anesthesia
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Stanford University Medical Center
Stanford, California, 94304
Subhas Banerjee, 650-723-2623, sbanerje@stanford.edu
About this study
Official title: Comparison of Standard Endotracheal Intubation [SEI] and Endoscope Assisted Endotracheal Intubation [EAE]
Comparison of standard endotracheal intubation and endoscopist-facilitated endotracheal intubation
Read the 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.
- Conditions
- Biliary Tract Diseases, Pancreatic Diseases
- Being tested
- Endoscope assisted endotracheal intubation [EAEI]
- Keywords
- ERCP, Endoscopic Procedures, Anesthesia
- Medical subject headings
- Biliary Tract Diseases, Pancreatic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscope assisted endotracheal intubation [EAEI]Procedure or surgery
Also called Standard Endotracheal Intubation [SEI]
Endoscope assisted endotracheal intubation [EAEI] performed by anesthesiologist with endoscopist assistance.
| Study group | Role | What they receive |
|---|---|---|
| Standard Endotracheal Intubation (SEI) | Active comparator | 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. Receives: Procedure: Endoscope assisted endotracheal intubation [EAEI] |
| Endoscope assisted endotracheal intubation [EAEI] | Experimental | 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. Receives: Procedure: Endoscope assisted endotracheal intubation [EAEI] |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Procedure Start
Time from patient entry into procedure room to insertion of endoscope/start of procedure
Measured: up to 1 hour
Secondary outcomes (9)
Intubation Time (time from 'ready to intubate', to 'tube confirmation')
Endoscopy documentation
Measured: up to 1 hour
Patient positioning time
Recorded in endoscopy suite
Measured: up to 1 hour
Staff required for patient positioning
Recorded in endoscopy suite, # of staff
Measured: up to 20 minutes
Staff survey/assessment of ergonomic strain
Staff reporting of ergonomic strain encountered during the procedure scale of 1-5 to rate ergonomic strain,
Measured: up to 1 hour
Need for special positioning equipment
Documented based on procedure room observation, list of equipment
Measured: up to 20 minutes
Hypoxia (nadir O2 sat and duration), Arrhythmia, Hypotension
Evaluation of hypoxia during intubation
Measured: up to 20 minutes
Time from removal of GI endoscope to exit from procedure room
Documented in endoscopy suite
Measured: up to 60 minutes
Tooth/oropharyngeal trauma, skin/musculoskeletal trauma
Evaluation of oropharyngeal trauma and skin/musculoskeletal complaints following intubation, rating scale (0-5 to rate damage)
Measured: up to 24 hours post-procedure
Materials and facility fees
assessment of cost associated with procedures
Measured: up to 24 hours post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2019
- Study start30 Aug 2018
- Primary completionOct 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Biliary Tract DiseasesStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomization to standard endotracheal intubation or endoscopist-facilitated endotracheal intubation.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Subhas Banerjee, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03879720
- Sponsor's protocol ID
- 47089
- Status last verified
- Nov 2019
- First submitted
- 8 Mar 2019
- Last updated
- 8 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Barakat MT, Angelotti T, Ghosh S, Banerjee S. Prospective randomized comparison of endoscopist-facilitated endotracheal intubation and standard intubation for ERCP. Gastrointest Endosc. 2023 Sep;98(3):441-447. doi: 10.1016/j.gie.2023.02.032. Epub 2023 Mar 5.
PubMed 36878302
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Standard Endotracheal Intubation [SEI] and Endoscope Assisted Endotracheal Intubation [EAE]
- ClinicalTrials.gov ID
- NCT03879720
- Acronym / sponsor ID
- 47089
- Conditions
- Biliary Tract Diseases, Pancreatic Diseases
- Keywords
- ERCP, Endoscopic Procedures, Anesthesia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 30 Aug 2018 (actual)
- Primary completion
- Oct 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 19 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomization to standard endotracheal intubation or endoscopist-facilitated endotracheal intubation.
| Arm | Type | Receives |
|---|---|---|
| Standard Endotracheal Intubation (SEI) | Active comparator | Procedure: 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] | Experimental | Procedure: 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing ERCP at Stanford University Medical Center
Key exclusion criteria (2 listed)
- Unable to consent
- Contra-indication to general anesthesia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endoscope assisted endotracheal intubation [EAEI]Also: Standard Endotracheal Intubation [SEI]Endoscope assisted endotracheal intubation [EAEI] performed by anesthesiologist with endoscopist assistance. | Procedure or surgery | Endoscope assisted endotracheal intubation [EAEI], Standard Endotracheal Intubation (SEI) |
Primary outcome
Time to Procedure Start
Time frame: up to 1 hour
Time from patient entry into procedure room to insertion of endoscope/start of procedure
9 secondary outcomes
Intubation Time (time from 'ready to intubate', to 'tube confirmation')
Time frame: up to 1 hour
Patient positioning time
Time frame: up to 1 hour
Staff required for patient positioning
Time frame: up to 20 minutes
Staff survey/assessment of ergonomic strain
Time frame: up to 1 hour
Need for special positioning equipment
Time frame: up to 20 minutes
Hypoxia (nadir O2 sat and duration), Arrhythmia, Hypotension
Time frame: up to 20 minutes
Time from removal of GI endoscope to exit from procedure room
Time frame: up to 60 minutes
Tooth/oropharyngeal trauma, skin/musculoskeletal trauma
Time frame: up to 24 hours post-procedure
Materials and facility fees
Time frame: up to 24 hours post-procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2019.
- Derived from this study: PubMed 36878302Barakat MT, Angelotti T, Ghosh S, Banerjee S. Prospective randomized comparison of endoscopist-facilitated endotracheal intubation and standard intubation for ERCP. Gastrointest Endosc. 2023 Sep;98(3):441-447. doi: 10.1016/j.gie.2023.02.032. Epub 2023 Mar 5.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endoscope assisted endotracheal intubation [EAEI] in people with Biliary Tract Diseases and Pancreatic Diseases, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Subhas Banerjee (650-723-2623, sbanerje@stanford.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Procedure Start (time frame: up to 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03879720, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2019; AzTrials last refreshed its copy on 7 Nov 2026.