Trial Outcomes & Findings for Feasibility of Laryngeal Mask Airway Gastro on Patients Undergoing Endoscopic Retrograde Cholangiopancreatography for Pancreas and Bile Duct Disorders (NCT NCT03775681)

NCT ID: NCT03775681

Last Updated: 2021-04-27

Results Overview

Successful completion of ERCP with the LMA® Gastro™

Recruitment status

COMPLETED

Study phase

Target enrollment

33 participants

Primary outcome timeframe

Up to 3 months

Results posted on

2021-04-27

Participant Flow

Recruitment Period: January 2019 to July 2019

Participant milestones

Participant milestones
Measure	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™.
Overall Study STARTED	33
Overall Study COMPLETED	30
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Reasons for withdrawal
Measure	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™.
Overall Study Physician Decision	3

Baseline Characteristics

Feasibility of Laryngeal Mask Airway Gastro on Patients Undergoing Endoscopic Retrograde Cholangiopancreatography for Pancreas and Bile Duct Disorders

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	LMA® Gastro™ n=30 Participants 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™.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	15 Participants n=5 Participants
Age, Categorical >=65 years	15 Participants n=5 Participants
Age, Continuous	65 years n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants
Sex: Female, Male Male	18 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	NA Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	NA Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	NA Participants n=5 Participants
Region of Enrollment United States	30 participants n=5 Participants
Type of Endoscopic Retrograde Cholangiopancreatography (ERCP) Stent Placement	12 Participants n=5 Participants
Type of Endoscopic Retrograde Cholangiopancreatography (ERCP) Stent Removal	9 Participants n=5 Participants
Type of Endoscopic Retrograde Cholangiopancreatography (ERCP) Stent Exchange	4 Participants n=5 Participants
Type of Endoscopic Retrograde Cholangiopancreatography (ERCP) Diagnostic	3 Participants n=5 Participants
Type of Endoscopic Retrograde Cholangiopancreatography (ERCP) Other	2 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 3 months

Successful completion of ERCP with the LMA® Gastro™

Outcome measures

Outcome measures
Measure	LMA® Gastro™ n=30 Participants 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™.
The Number of Participants With Overall Success of ERCP With LMA Gastro	28 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	LMA® Gastro™ n=30 Participants 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™.
Gastroenterologist and Anesthesiologist Satisfaction With the LMA® Gastro™ Discordance	3.45 score on a scale Interval 0.0 to 100.0
Gastroenterologist and Anesthesiologist Satisfaction With the LMA® Gastro™ Concordance	96.55 score on a scale Interval 0.0 to 100.0

Adverse Events

LMA® Gastro™

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Katherine Hagan, Associate Professor, Anesthesiology & PeriOper Med

UT MD Anderson Cancer Center

Phone: (713) 794-5945

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place