Bile Duct CarcinomaNCT04740164
A Dual Channel Supraglottic Airway Device (LMA Gastro) for Oxygenation in Patients Undergoing ERCP
A study testing Endoscopic Retrograde Cholangiopancreatography in people with Bile Duct Carcinoma and Gallbladder Carcinoma, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
This clinical trial compares the effect of LMA Gastro, a dual channel supraglottic airway (SGA) device, to oxygenation with standard nasal cannula for endoscopic retrograde cholangiopancreatography (ERCP). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bile Duct Carcinoma, Gallbladder Carcinoma, Pancreatic Ductal Adenocarcinoma
- What is being tested?
- Endoscopic Retrograde Cholangiopancreatography
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Feb 2021to 4 May 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Adult patients (>= 18 years old) undergoing ERCP
Who cannot join
- Patients with propofol allergy
- Patients at increased aspiration risk
- Patients with abnormal head/neck pathology preventing LMA Gastro placement
- Patients with surgical or radiation treatment to the head/neck making LMA Gastro placement difficult
- Patient with known difficult airway requiring advanced intubation equipment (with the exception of the video-laryngoscope) in the past
- Esophagectomy patients
Show all 11Show fewer
- Patients already intubated upon arrival to endoscopy suite
- Patients undergoing endoscopic ultrasound (EUS)
- Patients with body mass index (BMI) >= 35 kg/m^2
- Patients with hypoxemia (SpO2 < 94% on room air or on home oxygen)
- American Society of Anesthesiology (ASA) Physical Status IV-V
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Study to Compare LMA® Gastro™, a Dual Channel Supraglottic Airway (SGA) Device, to Oxygenation With Standard Nasal Cannula for Endoscopic Retrograde Cholangiopancreatography (ERCP)
This clinical trial compares the effect of LMA Gastro, a dual channel supraglottic airway (SGA) device, to oxygenation with standard nasal cannula for endoscopic retrograde cholangiopancreatography (ERCP). An ERCP is a combination of imaging scans and endoscopy that helps doctors diagnose and treat conditions of the pancreas and bile ducts that requires general anesthesia or procedural sedation. Anesthesiologists often use SGAs or nasal cannulas to help patients breathe while they are asleep during procedures. An SGA consists of an airway tube that connects to a mask, which is inserted through the mouth and placed at the back of the throat to keep the airway open while patients are under anesthesia or sedation. The nasal cannula is a device that fits in a patient's nostrils and delivers oxygen through a small, flexible tube while they are under anesthesia or sedation. The goal of this trial is to compare the effects of the LMA Gastro to nasal cannula when used to deliver oxygen to patients while they are asleep during their ERCP procedure.
Read the detailed description
PRIMARY OBJECTIVE:
- To compare the incidence of desaturation (oxygen saturation [SpO2] < 90%) between patients undergoing ERCP with LMA Gastro versus (vs) standard nasal cannula.
SECONDARY OBJECTIVES:
- To evaluate the incidence of additional airway maneuvers (jaw thrust/chin lift/placement of oral airway or/nasal trumpet/intubation).
II. To evaluate the incidence of withdrawal of duodenoscope from the airway to facilitate airway support.
III. To evaluate the incidence of adverse events. IV. To evaluate times related to anesthesia and procedure (defined as "anesthesia start to anesthesia end" and "procedure start to procedure end" respectively).
- To evaluate time from procedure end to anesthesia end. VI. To describe hemodynamics within the two groups (recorded blood pressures, heart rates, oxygen saturations, and end tidal carbon dioxide [CO2]).
VII. To evaluate anesthesiologist placing the device (training video viewed, number of practice attempts, years of experience).
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients undergo ERCP with LMA Gastro.
ARM II: Patients undergo ERCP with standard nasal cannula.
- Being tested
- Endoscopic Retrograde Cholangiopancreatography
- Medical subject headings
- Bile Duct Neoplasms, Gallbladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic Retrograde CholangiopancreatographyProcedure or surgery
Also called ERCP
Undergo ERCP with LMA Gastro
Endoscopic Retrograde CholangiopancreatographyProcedure or surgery
Also called ERCP
Undergo ERCP with standard nasal cannula
| Study group | Role | What they receive |
|---|---|---|
| Arm I (ERCP with LMA Gastro) | Experimental | Patients undergo ERCP with LMA Gastro. Receives: Procedure: Endoscopic Retrograde Cholangiopancreatography |
| Arm II (ERCP with standard nasal cannula) | Active comparator | Patients undergo ERCP with standard nasal cannula. Receives: Procedure: Endoscopic Retrograde Cholangiopancreatography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants That Had Desaturation Episodes of SpO2 <90%
The desaturation (SpO2 < 90%) between patients undergoing ERCP with LMA® Gastro™ vs standard nasal cannula
Measured: The time between Anesthesia Start time and Anesthesia End time, 1.5 hrs in average
Secondary outcomes (9)
Incidence of Additional Airway Maneuvers
Number of Participants that required additional manuevers to secure airway during their surgery
Measured: The time between Anesthesia Start time and Anesthesia End time, 1.5 hrs in average
Incidence of Withdrawal of Duodenoscope From Airway to Facilitate Airway Support
Patients in which Duodenoscope was withdrawn to facilitate airway support
Measured: The time between Anesthesia Start time and Anesthesia End time
Incidence of Adverse Events
Number of adverse events reported by the participants and/or reported by care providers during Surgery and in PACU, 3 hrs in average
Measured: From PACU arrival to PACU discharge, 3 hours in average
To Evaluate Times Related to Anesthesia and Procedure
Defined as "anesthesia start to anesthesia end" and "procedure start to procedure end" respectively
Measured: From anesthesia start to anesthesia end" and "procedure start to procedure end, up to 165 minutes
To Evaluate Time From Procedure End to Anesthesia End
The time elapsed between procedure end and anesthesia end
Measured: From procedure end and anesthesia end, up to 60 minutes
To Describe Heart Rates Within the Two Groups
Heart rates were measured prior treatment administration and at the end of the procedure.
Measured: From "anesthesia start" to "anesthesia end", on average 5 hours
To Describe Blood Pressure and End Tidal Carbon Dioxide [CO2] Within the Two Groups
Blood pressure and end tidal carbon dioxide [CO2] were measured prior treatment administration and at the end of the procedure.
Measured: From "anesthesia start" to "anesthesia end", on average 5 hours
To Describe Oxygen Saturations Within the Two Groups
Oxygen saturations were measured prior treatment administration and at the end of the procedure.
Measured: From "anesthesia start" to "anesthesia end", on average 5 hours
To Evaluate Anesthesiologist Placing the Device
Number of attempts means how many times the anesthesiologist tried to secure airway.
Measured: At the end of procedure, between 5 - 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2021
- Study start24 Feb 2021
- Primary completion4 May 2023
- Study completion4 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Bile Duct CarcinomaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe 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
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Katherine Hagan, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04740164
- Sponsor's protocol ID
- 2020-1014
- Other IDs
- NCI-2021-00118, 2020-1014
- Status last verified
- Nov 2024
- First submitted
- 29 Jan 2021
- Last updated
- 6 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Study to Compare LMA® Gastro™, a Dual Channel Supraglottic Airway (SGA) Device, to Oxygenation With Standard Nasal Cannula for Endoscopic Retrograde Cholangiopancreatography (ERCP)
- ClinicalTrials.gov ID
- NCT04740164
- Acronym / sponsor ID
- 2020-1014
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 24 Feb 2021 (actual)
- Primary completion
- 4 May 2023 (actual)
- Study completion
- 4 May 2023 (actual)
- First posted
- 5 Feb 2021 (actual)
- Results
- Posted 6 Nov 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This clinical trial compares the effect of LMA Gastro, a dual channel supraglottic airway (SGA) device, to oxygenation with standard nasal cannula for endoscopic retrograde cholangiopancreatography (ERCP). An ERCP is a combination of imaging scans and endoscopy that helps doctors diagnose and treat conditions of the pancreas and bile ducts that requires general anesthesia or procedural sedation. Anesthesiologists often use SGAs or nasal cannulas to help patients breathe while they are asleep during procedures. An SGA consists of an airway tube that connects to a mask, which is inserted through the mouth and placed at the back of the throat to keep the airway open while patients are under anesthesia or sedation. The nasal cannula is a device that fits in a patient's nostrils and delivers oxygen through a small, flexible tube while they are under anesthesia or sedation. The goal of this trial is to compare the effects of the LMA Gastro to nasal cannula when used to deliver oxygen to patients while they are asleep during their ERCP procedure.
Detailed description
PRIMARY OBJECTIVE:
- To compare the incidence of desaturation (oxygen saturation [SpO2] < 90%) between patients undergoing ERCP with LMA Gastro versus (vs) standard nasal cannula.
SECONDARY OBJECTIVES:
- To evaluate the incidence of additional airway maneuvers (jaw thrust/chin lift/placement of oral airway or/nasal trumpet/intubation).
II. To evaluate the incidence of withdrawal of duodenoscope from the airway to facilitate airway support.
III. To evaluate the incidence of adverse events. IV. To evaluate times related to anesthesia and procedure (defined as "anesthesia start to anesthesia end" and "procedure start to procedure end" respectively).
- To evaluate time from procedure end to anesthesia end. VI. To describe hemodynamics within the two groups (recorded blood pressures, heart rates, oxygen saturations, and end tidal carbon dioxide [CO2]).
VII. To evaluate anesthesiologist placing the device (training video viewed, number of practice attempts, years of experience).
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients undergo ERCP with LMA Gastro.
ARM II: Patients undergo ERCP with standard nasal cannula.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (ERCP with LMA Gastro) | Experimental | Procedure: Endoscopic Retrograde CholangiopancreatographyPatients undergo ERCP with LMA Gastro. |
| Arm II (ERCP with standard nasal cannula) | Active comparator | Procedure: Endoscopic Retrograde CholangiopancreatographyPatients undergo ERCP with standard nasal cannula. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients (>= 18 years old) undergoing ERCP
Key exclusion criteria (11 listed)
- Patients with propofol allergy
- Patients at increased aspiration risk
- Patients with abnormal head/neck pathology preventing LMA Gastro placement
- Patients with surgical or radiation treatment to the head/neck making LMA Gastro placement difficult
- Patient with known difficult airway requiring advanced intubation equipment (with the exception of the video-laryngoscope) in the past
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 |
|---|---|---|
| Endoscopic Retrograde CholangiopancreatographyAlso: ERCPUndergo ERCP with LMA Gastro | Procedure or surgery | Arm I (ERCP with LMA Gastro) |
| Endoscopic Retrograde CholangiopancreatographyAlso: ERCPUndergo ERCP with standard nasal cannula | Procedure or surgery | Arm II (ERCP with standard nasal cannula) |
Primary outcome
Number of Participants That Had Desaturation Episodes of SpO2 <90%
Time frame: The time between Anesthesia Start time and Anesthesia End time, 1.5 hrs in average
The desaturation (SpO2 < 90%) between patients undergoing ERCP with LMA® Gastro™ vs standard nasal cannula
9 secondary outcomes
Incidence of Additional Airway Maneuvers
Time frame: The time between Anesthesia Start time and Anesthesia End time, 1.5 hrs in average
Incidence of Withdrawal of Duodenoscope From Airway to Facilitate Airway Support
Time frame: The time between Anesthesia Start time and Anesthesia End time
Incidence of Adverse Events
Time frame: From PACU arrival to PACU discharge, 3 hours in average
To Evaluate Times Related to Anesthesia and Procedure
Time frame: From anesthesia start to anesthesia end" and "procedure start to procedure end, up to 165 minutes
To Evaluate Time From Procedure End to Anesthesia End
Time frame: From procedure end and anesthesia end, up to 60 minutes
To Describe Heart Rates Within the Two Groups
Time frame: From "anesthesia start" to "anesthesia end", on average 5 hours
To Describe Blood Pressure and End Tidal Carbon Dioxide [CO2] Within the Two Groups
Time frame: From "anesthesia start" to "anesthesia end", on average 5 hours
To Describe Oxygen Saturations Within the Two Groups
Time frame: From "anesthesia start" to "anesthesia end", on average 5 hours
To Evaluate Anesthesiologist Placing the Device
Time frame: At the end of procedure, between 5 - 10 minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- M D Anderson Cancer CenterLink provided by the sponsor.
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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.
Katherine Hagan principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endoscopic Retrograde Cholangiopancreatography in people with Bile Duct Carcinoma and Gallbladder Carcinoma, run by M.D. Anderson Cancer Center 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 11 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 Nov 2024. 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?
Yes. Results are posted in the registry (first posted 6 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants That Had Desaturation Episodes of SpO2 <90% (time frame: The time between Anesthesia Start time and Anesthesia End time, 1.5 hrs in average). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Nov 2024.