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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2021-00118 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 2020-1014 | Other Identifier | M D Anderson Cancer Center |
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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.
PRIMARY OBJECTIVE:
I. To compare the incidence of desaturation (oxygen saturation [SpO2] < 90%) between patients undergoing ERCP with LMA Gastro versus (vs) standard nasal cannula.
SECONDARY OBJECTIVES:
I. 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).
V. 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (ERCP with LMA Gastro) | Experimental | Patients undergo ERCP with LMA Gastro. |
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| Arm II (ERCP with standard nasal cannula) | Active Comparator | Patients undergo ERCP with standard nasal cannula. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endoscopic Retrograde Cholangiopancreatography | Procedure | Undergo ERCP with LMA Gastro |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | The time between Anesthesia Start time and Anesthesia End time, 1.5 hrs in average |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Additional Airway Maneuvers | Number of Participants that required additional manuevers to secure airway during their surgery | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Katherine Hagan | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| M D Anderson Cancer Center | Houston | Texas | 77030 | United States |
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| Label | URL |
|---|---|
| M D Anderson Cancer Center | View source |
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This study enrolled 66 patients from 02/24/2021 to 06/24/2022. Patients ≥18 years old undergoing elective ERCP with TIVA were eligible for enrollment.
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| ID | Title | Description |
|---|---|---|
| FG000 | LMA Gastro | This group of patients received GA during their procedure, using LMA Gastro for intubation. |
| FG001 | Standard of Care | This group received TIVA during their procedure. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 23, 2022 |
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| Endoscopic Retrograde Cholangiopancreatography | Procedure | Undergo ERCP with standard nasal cannula |
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Patients in which Duodenoscope was withdrawn to facilitate airway support |
| 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 | 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 | 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 | 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. | 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. | 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. | 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. | At the end of procedure, between 5 - 10 minutes |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | LMA Gastro | This group of patients received GA during their procedure, using LMA Gastro for intubation. |
| BG001 | Standard of Care | This group received TIVA during their procedure. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| ASA Status (grade) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Count of Participants | Participants | The time between Anesthesia Start time and Anesthesia End time, 1.5 hrs in average |
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| Secondary | Incidence of Additional Airway Maneuvers | Number of Participants that required additional manuevers to secure airway during their surgery | Posted | Count of Participants | Participants | The time between Anesthesia Start time and Anesthesia End time, 1.5 hrs in average |
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| Secondary | Incidence of Withdrawal of Duodenoscope From Airway to Facilitate Airway Support | Patients in which Duodenoscope was withdrawn to facilitate airway support | Posted | Count of Participants | Participants | The time between Anesthesia Start time and Anesthesia End time |
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| Secondary | 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 | Posted | Number | events | From PACU arrival to PACU discharge, 3 hours in average |
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| Secondary | To Evaluate Times Related to Anesthesia and Procedure | Defined as "anesthesia start to anesthesia end" and "procedure start to procedure end" respectively | Posted | Mean | Full Range | minutes | From anesthesia start to anesthesia end" and "procedure start to procedure end, up to 165 minutes |
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| Secondary | To Evaluate Time From Procedure End to Anesthesia End | The time elapsed between procedure end and anesthesia end | Posted | Mean | Full Range | minutes | From procedure end and anesthesia end, up to 60 minutes |
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| Secondary | To Describe Heart Rates Within the Two Groups | Heart rates were measured prior treatment administration and at the end of the procedure. | Posted | Mean | Standard Deviation | bpm | From "anesthesia start" to "anesthesia end", on average 5 hours |
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| Secondary | 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. | Posted | Mean | Standard Deviation | mmhg | From "anesthesia start" to "anesthesia end", on average 5 hours |
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| Secondary | To Describe Oxygen Saturations Within the Two Groups | Oxygen saturations were measured prior treatment administration and at the end of the procedure. | Posted | Mean | Standard Deviation | percentage of saturation | From "anesthesia start" to "anesthesia end", on average 5 hours |
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| Secondary | To Evaluate Anesthesiologist Placing the Device | Number of attempts means how many times the anesthesiologist tried to secure airway. | This outcome is evaluating the providers not participants. This outcome is only applicable to the LMA Gastro arm since it is in this arm we are using the study device. | Posted | Number | percentage of successful attempts | At the end of procedure, between 5 - 10 minutes |
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Since anesthesia start to discharge ready in PACU, up to 5 hours
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | LMA Gastro | This group of patients received GA during their procedure, using LMA Gastro for intubation. | 0 | 26 | 0 | 26 | 24 | 26 |
| EG001 | Standard of Care | This group received TIVA during their procedure. | 0 | 30 | 0 | 30 | 3 | 30 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Horseness | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Sore throat | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Sore mouth | General disorders | Systematic Assessment |
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| Sore Jaw | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Dysphagia | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Katherine Hagan | The University of Texas MD Anderson Cancer Center | (713) 794-5945 | khagan@mdanderson.org |
| Jul 31, 2024 |
| Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D001650 | Bile Duct Neoplasms |
| D005706 | Gallbladder Neoplasms |
| ID | Term |
|---|---|
| D001661 | Biliary Tract Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001649 | Bile Duct Diseases |
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
| D005705 | Gallbladder Diseases |
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| ID | Term |
|---|---|
| D002760 | Cholangiopancreatography, Endoscopic Retrograde |
| ID | Term |
|---|---|
| D002758 | Cholangiography |
| D011860 | Radiography, Abdominal |
| D011859 | Radiography |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D003938 | Diagnostic Techniques, Digestive System |
| D016145 | Endoscopy, Digestive System |
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |
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| III (worse) |
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