Bile Duct Disorder, Endocrine Pancreas Disorder
Conditions
Brief summary
This trial determines the feasibility of Laryngeal Mask Airway Gastro (Laryngeal Mask Airway) when used on patients who are undergoing endoscopic retrograde cholangiopancreatography for pancreas and bile duct disorders. Laryngeal Mask Airway is a device that helps patients breathe while they are asleep during procedures.
Detailed description
PRIMARY OBJECTIVES: I. To determine the successful completion of endoscopic retrograde cholangiopancreatography (ERCP) with the Laryngeal Mask Airway (LMA) Gastro. SECONDARY OBJECTIVES: I. To determine gastroenterologist satisfaction with the LMA Gastro. II. To determine anesthesia provider satisfaction with the LMA Gastro. III. To determine the rate of unsuccessful LMA Gastro placement. IV. To determine the ability of LMA Gastro to provide adequate oxygenation and ventilation throughout the procedure. V. To determine and describe the rate of adverse events. OUTLINE: Patients wear Laryngeal Mask Airway Gastro after receiving general anesthesia and falling asleep. Patients then undergo standard of care endoscopic retrograde cholangiopancreatography. Patients also complete a 5-minute interview following ERCP procedure.
Interventions
PROCEDUREEndoscopic Retrograde Cholangiopancreatography
Undergo standard of care ERCP
OTHERInterview
Ancillary studies
DEVICELaryngeal Mask Airway
Wear LMA
Sponsors
National Cancer Institute (NCI)
M.D. Anderson Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patients undergoing elective ERCP with general anesthesia
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 * 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 * Non-English speaking patients
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Number of Participants With Overall Success of ERCP With LMA Gastro | Up to 3 months | Successful completion of ERCP with the LMA® Gastro™ |
Other
| Measure | Time frame | Description |
|---|---|---|
| Gastroenterologist and Anesthesiologist Satisfaction With the LMA® Gastro™ | Up to 3 months | Surveys for gastroenterologist and anesthesiologist satisfaction with the Laryngeal Mask Airway (LMA) Gastro contain items measured on a 10-point Likert scale with 1 reflecting strong disagreement and 10 strong agreement. Mean scores and standard deviations will be used to provide summaries for each survey item. Summaries will be stratified by gastroenterologist and anesthesiologist. Paired differences in survey items between gastroenterologist and anesthesiologist scores will be summarized using descriptive statistics and 95% CIs. |
Countries
United States
Participant flow
Recruitment details
Recruitment Period: January 2019 to July 2019
Participants by arm
| Arm | Count |
|---|---|
| LMA® Gastro™ Upon anesthesia induction, the LMA® Gastro™ was placed in the patient's oropharynx. The cuff was inflated until the cuff pilot indicator line was within the green zone. Appropriate placement was confirmed with end tidal CO2 and adequate tidal volumes of at least 4-5 cc/kg. The LMA® Gastro™ was secured using the manufacturer provided adjustable holder and strap. A standard sideviewing duodenoscope measuring 11.3mm in maximum diameter was lubricated with KY jelly by the gastroenterologist, coating the full length of the endoscope that was inserted into the LMA® Gastro™. | 30 |
| Total | 30 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Physician Decision | 3 |
Baseline characteristics
| Characteristic | LMA® Gastro™ |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 15 Participants |
| Age, Categorical Between 18 and 65 years | 15 Participants |
| Age, Continuous | 65 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | NA Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | NA Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | NA Participants |
| Region of Enrollment United States | 30 participants |
| Sex: Female, Male Female | 12 Participants |
| Sex: Female, Male Male | 18 Participants |
| Type of Endoscopic Retrograde Cholangiopancreatography (ERCP) Diagnostic | 3 Participants |
| Type of Endoscopic Retrograde Cholangiopancreatography (ERCP) Other | 2 Participants |
| Type of Endoscopic Retrograde Cholangiopancreatography (ERCP) Stent Exchange | 4 Participants |
| Type of Endoscopic Retrograde Cholangiopancreatography (ERCP) Stent Placement | 12 Participants |
| Type of Endoscopic Retrograde Cholangiopancreatography (ERCP) Stent Removal | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 30 |
| other Total, other adverse events | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 |
Outcome results
Primary
The Number of Participants With Overall Success of ERCP With LMA Gastro
Successful completion of ERCP with the LMA® Gastro™
Time frame: Up to 3 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| LMA® Gastro™ | The Number of Participants With Overall Success of ERCP With LMA Gastro | 28 Participants |
Other Pre-specified
Gastroenterologist and Anesthesiologist Satisfaction With the LMA® Gastro™
Surveys for gastroenterologist and anesthesiologist satisfaction with the Laryngeal Mask Airway (LMA) Gastro contain items measured on a 10-point Likert scale with 1 reflecting strong disagreement and 10 strong agreement. Mean scores and standard deviations will be used to provide summaries for each survey item. Summaries will be stratified by gastroenterologist and anesthesiologist. Paired differences in survey items between gastroenterologist and anesthesiologist scores will be summarized using descriptive statistics and 95% CIs.
Time frame: Up to 3 months
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| LMA® Gastro™ | Gastroenterologist and Anesthesiologist Satisfaction With the LMA® Gastro™ | Discordance | 3.45 score on a scale |
| LMA® Gastro™ | Gastroenterologist and Anesthesiologist Satisfaction With the LMA® Gastro™ | Concordance | 96.55 score on a scale |