Bile Duct Carcinoma, Gallbladder Carcinoma, Pancreatic Ductal Adenocarcinoma
Conditions
Brief 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). 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: 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.
Interventions
PROCEDUREEndoscopic Retrograde Cholangiopancreatography
Undergo ERCP with LMA Gastro
Sponsors
M.D. Anderson Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patients (\>= 18 years old) undergoing ERCP
Exclusion criteria
* 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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants That Had Desaturation Episodes of SpO2 <90% | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Withdrawal of Duodenoscope From Airway to Facilitate Airway Support | The time between Anesthesia Start time and Anesthesia End time | Patients in which Duodenoscope was withdrawn to facilitate airway support |
| Incidence of Adverse Events | From PACU arrival to PACU discharge, 3 hours in average | Number of adverse events reported by the participants and/or reported by care providers during Surgery and in PACU, 3 hrs in average |
| To Evaluate Times Related to Anesthesia and Procedure | From anesthesia start to anesthesia end and procedure start to procedure end, up to 165 minutes | Defined as anesthesia start to anesthesia end and procedure start to procedure end respectively |
| To Evaluate Time From Procedure End to Anesthesia End | From procedure end and anesthesia end, up to 60 minutes | The time elapsed between procedure end and anesthesia end |
| Incidence of Additional Airway Maneuvers | The time between Anesthesia Start time and Anesthesia End time, 1.5 hrs in average | Number of Participants that required additional manuevers to secure airway during their surgery |
| To Describe Blood Pressure and End Tidal Carbon Dioxide [CO2] Within the Two Groups | From anesthesia start to anesthesia end, on average 5 hours | Blood pressure and end tidal carbon dioxide \[CO2\] were measured prior treatment administration and at the end of the procedure. |
| To Describe Oxygen Saturations Within the Two Groups | From anesthesia start to anesthesia end, on average 5 hours | Oxygen saturations were measured prior treatment administration and at the end of the procedure. |
| To Evaluate Anesthesiologist Placing the Device | At the end of procedure, between 5 - 10 minutes | Number of attempts means how many times the anesthesiologist tried to secure airway. |
| To Describe Heart Rates Within the Two Groups | From anesthesia start to anesthesia end, on average 5 hours | Heart rates were measured prior treatment administration and at the end of the procedure. |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| LMA Gastro This group of patients received GA during their procedure, using LMA Gastro for intubation. | 26 |
| Standard of Care This group received TIVA during their procedure. | 30 |
| Total | 56 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lack of Efficacy | 4 | 0 |
| Overall Study | Physician Decision | 3 | 3 |
Baseline characteristics
| Characteristic | Standard of Care | Total | LMA Gastro |
|---|---|---|---|
| Age, Continuous | 62.8667 years | 59.96 years | 56.6154 years |
| ASA Status (grade) II (better) | 1 Participants | 1 Participants | 0 Participants |
| ASA Status (grade) III (worse) | 29 Participants | 55 Participants | 26 Participants |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 30 participants | 56 participants | 26 participants |
| Sex: Female, Male Female | 8 Participants | 23 Participants | 15 Participants |
| Sex: Female, Male Male | 22 Participants | 33 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 26 | 0 / 30 |
| other Total, other adverse events | 24 / 26 | 3 / 30 |
| serious Total, serious adverse events | 0 / 26 | 0 / 30 |
Outcome results
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
Time frame: The time between Anesthesia Start time and Anesthesia End time, 1.5 hrs in average
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| LMA Gastro | Number of Participants That Had Desaturation Episodes of SpO2 <90% | Desaturation <90% - Yes | 0 Participants |
| LMA Gastro | Number of Participants That Had Desaturation Episodes of SpO2 <90% | Desaturation <90% - No | 26 Participants |
| Standard of Care | Number of Participants That Had Desaturation Episodes of SpO2 <90% | Desaturation <90% - Yes | 3 Participants |
| Standard of Care | Number of Participants That Had Desaturation Episodes of SpO2 <90% | Desaturation <90% - No | 27 Participants |
Secondary
Incidence of Additional Airway Maneuvers
Number of Participants that required additional manuevers to secure airway during their surgery
Time frame: The time between Anesthesia Start time and Anesthesia End time, 1.5 hrs in average
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| LMA Gastro | Incidence of Additional Airway Maneuvers | Yes | 5 Participants |
| LMA Gastro | Incidence of Additional Airway Maneuvers | No | 21 Participants |
| Standard of Care | Incidence of Additional Airway Maneuvers | Yes | 19 Participants |
| Standard of Care | Incidence of Additional Airway Maneuvers | No | 11 Participants |
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
Time frame: From PACU arrival to PACU discharge, 3 hours in average
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| LMA Gastro | Incidence of Adverse Events | 24 events |
| Standard of Care | Incidence of Adverse Events | 3 events |
Secondary
Incidence of Withdrawal of Duodenoscope From Airway to Facilitate Airway Support
Patients in which Duodenoscope was withdrawn to facilitate airway support
Time frame: The time between Anesthesia Start time and Anesthesia End time
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| LMA Gastro | Incidence of Withdrawal of Duodenoscope From Airway to Facilitate Airway Support | Yes | 9 Participants |
| LMA Gastro | Incidence of Withdrawal of Duodenoscope From Airway to Facilitate Airway Support | No | 17 Participants |
| Standard of Care | Incidence of Withdrawal of Duodenoscope From Airway to Facilitate Airway Support | Yes | 10 Participants |
| Standard of Care | Incidence of Withdrawal of Duodenoscope From Airway to Facilitate Airway Support | No | 20 Participants |
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.
Time frame: From anesthesia start to anesthesia end, on average 5 hours
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| LMA Gastro | To Describe Blood Pressure and End Tidal Carbon Dioxide [CO2] Within the Two Groups | Systolic Blood pressure prior to intervention | 127.2308 mmhg | Standard Deviation 19.4757 |
| LMA Gastro | To Describe Blood Pressure and End Tidal Carbon Dioxide [CO2] Within the Two Groups | Systolic Blood pressure post intervention | 122.0769 mmhg | Standard Deviation 15.0676 |
| LMA Gastro | To Describe Blood Pressure and End Tidal Carbon Dioxide [CO2] Within the Two Groups | Diastolic Blood pressure prior to intervention | 78.3462 mmhg | Standard Deviation 10.7664 |
| LMA Gastro | To Describe Blood Pressure and End Tidal Carbon Dioxide [CO2] Within the Two Groups | Diastolic Blood pressure post intervention | 76.9231 mmhg | Standard Deviation 10.0833 |
| LMA Gastro | To Describe Blood Pressure and End Tidal Carbon Dioxide [CO2] Within the Two Groups | End tidal carbon dioxide [CO2] prior to intervention | 18.6364 mmhg | Standard Deviation 11.4129 |
| LMA Gastro | To Describe Blood Pressure and End Tidal Carbon Dioxide [CO2] Within the Two Groups | End tidal carbon dioxide [CO2] post intervention | 22.0769 mmhg | Standard Deviation 9.1693 |
| Standard of Care | To Describe Blood Pressure and End Tidal Carbon Dioxide [CO2] Within the Two Groups | End tidal carbon dioxide [CO2] prior to intervention | 25.2 mmhg | Standard Deviation 11.7858 |
| Standard of Care | To Describe Blood Pressure and End Tidal Carbon Dioxide [CO2] Within the Two Groups | Systolic Blood pressure prior to intervention | 137.5714 mmhg | Standard Deviation 28.3097 |
| Standard of Care | To Describe Blood Pressure and End Tidal Carbon Dioxide [CO2] Within the Two Groups | Diastolic Blood pressure post intervention | 77.7 mmhg | Standard Deviation 15.0611 |
| Standard of Care | To Describe Blood Pressure and End Tidal Carbon Dioxide [CO2] Within the Two Groups | Systolic Blood pressure post intervention | 128.2 mmhg | Standard Deviation 23.5231 |
| Standard of Care | To Describe Blood Pressure and End Tidal Carbon Dioxide [CO2] Within the Two Groups | End tidal carbon dioxide [CO2] post intervention | 28.75 mmhg | Standard Deviation 10.707 |
| Standard of Care | To Describe Blood Pressure and End Tidal Carbon Dioxide [CO2] Within the Two Groups | Diastolic Blood pressure prior to intervention | 80.8571 mmhg | Standard Deviation 15.1846 |
Secondary
To Describe Heart Rates Within the Two Groups
Heart rates were measured prior treatment administration and at the end of the procedure.
Time frame: From anesthesia start to anesthesia end, on average 5 hours
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| LMA Gastro | To Describe Heart Rates Within the Two Groups | Heart rate prior to intervention | 79.8846 bpm | Standard Deviation 16.7412 |
| LMA Gastro | To Describe Heart Rates Within the Two Groups | Heart rate post intervention | 77.1154 bpm | Standard Deviation 15.8501 |
| Standard of Care | To Describe Heart Rates Within the Two Groups | Heart rate prior to intervention | 77.3667 bpm | Standard Deviation 13.7853 |
| Standard of Care | To Describe Heart Rates Within the Two Groups | Heart rate post intervention | 66.9667 bpm | Standard Deviation 10.3607 |
Secondary
To Describe Oxygen Saturations Within the Two Groups
Oxygen saturations were measured prior treatment administration and at the end of the procedure.
Time frame: From anesthesia start to anesthesia end, on average 5 hours
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| LMA Gastro | To Describe Oxygen Saturations Within the Two Groups | Oxygen saturation prior to intervention | 98.5769 percentage of saturation | Standard Deviation 1.9426 |
| LMA Gastro | To Describe Oxygen Saturations Within the Two Groups | Oxygen saturation post intervention | 93.7692 percentage of saturation | Standard Deviation 1.6796 |
| Standard of Care | To Describe Oxygen Saturations Within the Two Groups | Oxygen saturation prior to intervention | 99.033 percentage of saturation | Standard Deviation 1.1885 |
| Standard of Care | To Describe Oxygen Saturations Within the Two Groups | Oxygen saturation post intervention | 98.5 percentage of saturation | Standard Deviation 1.9783 |
Secondary
To Evaluate Anesthesiologist Placing the Device
Number of attempts means how many times the anesthesiologist tried to secure airway.
Time frame: At the end of procedure, between 5 - 10 minutes
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| LMA Gastro | To Evaluate Anesthesiologist Placing the Device | Successful on Attempt 1 | 77 percentage of successful attempts |
| LMA Gastro | To Evaluate Anesthesiologist Placing the Device | Successful on Attempt 2 | 19 percentage of successful attempts |
| LMA Gastro | To Evaluate Anesthesiologist Placing the Device | Successful on Attempt 3 | 4 percentage of successful attempts |
Secondary
To Evaluate Time From Procedure End to Anesthesia End
The time elapsed between procedure end and anesthesia end
Time frame: From procedure end and anesthesia end, up to 60 minutes
| Arm | Measure | Value (MEAN) |
|---|---|---|
| LMA Gastro | To Evaluate Time From Procedure End to Anesthesia End | 18.5769 minutes |
| Standard of Care | To Evaluate Time From Procedure End to Anesthesia End | 11.2 minutes |
Secondary
To Evaluate Times Related to Anesthesia and Procedure
Defined as anesthesia start to anesthesia end and procedure start to procedure end respectively
Time frame: From anesthesia start to anesthesia end and procedure start to procedure end, up to 165 minutes
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| LMA Gastro | To Evaluate Times Related to Anesthesia and Procedure | Total Anesthesia Time | 75.0769 minutes |
| LMA Gastro | To Evaluate Times Related to Anesthesia and Procedure | Total Procedure Time | 32.6154 minutes |
| Standard of Care | To Evaluate Times Related to Anesthesia and Procedure | Total Anesthesia Time | 62.8667 minutes |
| Standard of Care | To Evaluate Times Related to Anesthesia and Procedure | Total Procedure Time | 45.5333 minutes |