Airway ManagementNCT02850887
Patient Positioning and Airway Management During ERCP
A study testing general endotracheal anesthesia and deep sedation without endotracheal intubation in people with Airway Management, run by Washington University School of Medicine at 1 site in United States.
Trial summary
The aim of this study is to determine the effect of airway management (a set of medical procedures performed to prevent airway blockage and thus ensure an open path between a patient's lungs and the atmosphere) during endoscopic retrograde cholangiopancreatography [(ERCP), a procedure commonly used to treat conditions… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Airway Management
- What is being tested?
- general endotracheal anesthesia and deep sedation without endotracheal intubation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jul 2016to 4 Jan 2018
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient undergoing ERCP without preceding endoscopic ultrasound (EUS)
- At least one of the following risk factors for adverse events during sedation:
- STOP-BANG score of 3 or higher
- Abdominal ascites on either physical exam or imaging within the last 14 days
- BMI greater than or equal to 35
- Chronic lung disease
Show all 9Show fewer
- ASA class 4
- Mallampati Class 4 airway (only hard palate visible)
- Concurrent moderate to heavy alcohol use (≥4 drinks/day for men and ≥3 drinks/day for women)
Who cannot join
- EUS preceding the ERCP
- Emergent indication for ERCP (eg cholangitis with septic shock)
- Presence of a tracheostomy
- Unstable airway
- Gastric outlet obstruction
- Altered foregut anatomy (eg Roux-en-Y gastric bypass, Billroth II)
- Inability to give informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine in St Louis
St Louis, Missouri, 63010
About this study
Official title: Patient Positioning and Airway Management During Endoscopic Retrograde Cholangiopancreatography ERCP and the Effect on Airway Complications and Procedure Outcomes in Patients With Risks for Anesthesia Adverse Events
The aim of this study is to determine the effect of airway management (a set of medical procedures performed to prevent airway blockage and thus ensure an open path between a patient's lungs and the atmosphere) during endoscopic retrograde cholangiopancreatography [(ERCP), a procedure commonly used to treat conditions of the bile ducts and pancreas] and the effect on airway complications (problems), time to biliary cannulation (access into bile duct) and total procedure duration (length of time). Two methods are being compared and studied: 1) general endotracheal anesthesia: an inhalation anesthetic (substance that blocks pain) technique in which anesthetic and respiratory gases pass through a tube placed in the trachea (throat) via the mouth or nose vs 2) deep sedation without endotracheal intubation: local anesthesia together with sedation (drug that produces sleep) and analgesia (drug that treats pain) only.
- Conditions
- Airway Management
- Being tested
- general endotracheal anesthesia, deep sedation without endotracheal intubation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
general endotracheal anesthesiaOther
sedation with the use of endotracheal intubation
deep sedation without endotracheal intubationOther
Also called monitored anesthesia care (MAC)
deep sedation without endotracheal airway management.
| Study group | Role | What they receive |
|---|---|---|
| general endotracheal anesthesia | Active comparator | an inhalation anesthetic (substance that blocks pain) technique in which anesthetic and respiratory gases pass through a tube placed in the trachea (throat) via the mouth or nose Receives: Other: general endotracheal anesthesia |
| deep sedation without endotracheal intubation | Active comparator | local anesthesia together with sedation (drug that produces sleep) and analgesia (drug that treats pain) only. Receives: Other: deep sedation without endotracheal intubation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of sedation related adverse events or the need for airway maneuvers
Measured: approximately one year
Secondary outcomes (5)
Procedure duration
Measured: intraoperative
Time to cannulation of intended duct system
Measured: during the procedure
Technical success of ERCP
Measured: approximately one year
Immediate ERCP adverse events
Measured: Adverse events within 24 hours of ERCP
Delayed adverse events
Measured: Adverse events occurring within 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2016 (estimated)
- Study start25 Jul 2016
- Primary completion29 Nov 2017
- Study completion4 Jan 2018
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 Airway ManagementStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02850887
- Sponsor's protocol ID
- 201605151
- Status last verified
- Feb 2018
- First submitted
- 21 Jul 2016
- Last updated
- 6 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Smith ZL, Mullady DK, Lang GD, Das KK, Hovis RM, Patel RS, Hollander TG, Elsner J, Ifune C, Kushnir VM. A randomized controlled trial evaluating general endotracheal anesthesia versus monitored anesthesia care and the incidence of sedation-related adverse events during ERCP in high-risk patients. Gastrointest Endosc. 2019 Apr;89(4):855-862. doi: 10.1016/j.gie.2018.09.001. Epub 2018 Sep 11.
PubMed 30217726
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Positioning and Airway Management During Endoscopic Retrograde Cholangiopancreatography ERCP and the Effect on Airway Complications and Procedure Outcomes in Patients With Risks for Anesthesia Adverse Events
- ClinicalTrials.gov ID
- NCT02850887
- Acronym / sponsor ID
- 201605151
- Conditions
- Airway Management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 25 Jul 2016 (actual)
- Primary completion
- 29 Nov 2017 (actual)
- Study completion
- 4 Jan 2018 (actual)
- First posted
- 1 Aug 2016 (estimated)
- 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.
The aim of this study is to determine the effect of airway management (a set of medical procedures performed to prevent airway blockage and thus ensure an open path between a patient's lungs and the atmosphere) during endoscopic retrograde cholangiopancreatography [(ERCP), a procedure commonly used to treat conditions of the bile ducts and pancreas] and the effect on airway complications (problems), time to biliary cannulation (access into bile duct) and total procedure duration (length of time). Two methods are being compared and studied: 1) general endotracheal anesthesia: an inhalation anesthetic (substance that blocks pain) technique in which anesthetic and respiratory gases pass through a tube placed in the trachea (throat) via the mouth or nose vs 2) deep sedation without endotracheal intubation: local anesthesia together with sedation (drug that produces sleep) and analgesia (drug that treats pain) only.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| general endotracheal anesthesia | Active comparator | Other: general endotracheal anesthesiaan inhalation anesthetic (substance that blocks pain) technique in which anesthetic and respiratory gases pass through a tube placed in the trachea (throat) via the mouth or nose |
| deep sedation without endotracheal intubation | Active comparator | Other: deep sedation without endotracheal intubationlocal anesthesia together with sedation (drug that produces sleep) and analgesia (drug that treats pain) only. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patient undergoing ERCP without preceding endoscopic ultrasound (EUS)
- At least one of the following risk factors for adverse events during sedation:
Key exclusion criteria (7 listed)
- EUS preceding the ERCP
- Emergent indication for ERCP (eg cholangitis with septic shock)
- Presence of a tracheostomy
- Unstable airway
- Gastric outlet obstruction
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 |
|---|---|---|
| general endotracheal anesthesiasedation with the use of endotracheal intubation | Other | general endotracheal anesthesia |
| deep sedation without endotracheal intubationAlso: monitored anesthesia care (MAC)deep sedation without endotracheal airway management. | Other | deep sedation without endotracheal intubation |
Primary outcome
Incidence of sedation related adverse events or the need for airway maneuvers
Time frame: approximately one year
5 secondary outcomes
Procedure duration
Time frame: intraoperative
Time to cannulation of intended duct system
Time frame: during the procedure
Technical success of ERCP
Time frame: approximately one year
Immediate ERCP adverse events
Time frame: Adverse events within 24 hours of ERCP
Delayed adverse events
Time frame: Adverse events occurring within 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2018.
- Derived from this study: PubMed 30217726Smith ZL, Mullady DK, Lang GD, Das KK, Hovis RM, Patel RS, Hollander TG, Elsner J, Ifune C, Kushnir VM. A randomized controlled trial evaluating general endotracheal anesthesia versus monitored anesthesia care and the incidence of sedation-related adverse events during ERCP in high-risk patients. Gastrointest Endosc. 2019 Apr;89(4):855-862. doi: 10.1016/j.gie.2018.09.001. Epub 2018 Sep 11.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing general endotracheal anesthesia and deep sedation without endotracheal intubation in people with Airway Management, run by Washington University School of Medicine 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 9 inclusion and 7 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: finished, as of the sponsor's last update on 6 Feb 2018. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of sedation related adverse events or the need for airway maneuvers (time frame: approximately one year). 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 NCT02850887, 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 6 Feb 2018.