Trial Outcomes & Findings for Endotracheal Tube Versus Laryngeal Mask Airway for Esophagogastroduodenoscopy (NCT NCT01936662)

Results Overview

Endoscopist was surveyed to determine their satisfaction with each of the airway devices. Endoscopist used the following satisfaction scale for each patient, regardless of the airway device used: 1. The airway device did not interfere at all with the ability to perform the scope. 2. The airway device presented some interference with the scope, but not enough to cause difficulty. 3. The airway device made it difficult to perform the endoscopy. 4. The airway device prevented the endoscopy from being performed.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

84 participants

Primary outcome timeframe

2 hours

Results posted on

2016-05-02

Participant Flow

Patients were recruited on the day of their scheduled endoscopic procedure in the outpatient clinic of a large children's hospital.

Patients were pre-screened for allergies to medications used and BMI's outside the 90th percentile. All other patients were eligible for enrollment.

Participant milestones

Participant milestones
Measure	LMA Used to Maintain Airway Patients randomized to LMA to maintain airway through EGD procedure	ETT Used to Maintain Airway Patients were randomized to ETT to maintain airway for EGD procedure. This is the standard of care at this hospital
Overall Study STARTED	42	42
Overall Study COMPLETED	42	42
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Endotracheal Tube Versus Laryngeal Mask Airway for Esophagogastroduodenoscopy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	LMA Used to Maintain Airway n=42 Participants Patients randomized to LMA to maintain airway through EGD procedure	ETT Used to Maintain Airway n=42 Participants Patients were randomized to ETT to maintain airway for EGD procedure. This is the standard of care at this hospital	Total n=84 Participants Total of all reporting groups
Age, Categorical <=18 years	42 Participants n=5 Participants	42 Participants n=7 Participants	84 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	10.4 years STANDARD_DEVIATION 6.2 • n=5 Participants	10.1 years STANDARD_DEVIATION 4.2 • n=7 Participants	10.2 years STANDARD_DEVIATION 5.2 • n=5 Participants
Sex: Female, Male Female	22 Participants n=5 Participants	22 Participants n=7 Participants	44 Participants n=5 Participants
Sex: Female, Male Male	20 Participants n=5 Participants	20 Participants n=7 Participants	40 Participants n=5 Participants
Region of Enrollment United States	42 participants n=5 Participants	42 participants n=7 Participants	84 participants n=5 Participants

PRIMARY outcome

Timeframe: 2 hours

Endoscopist was surveyed to determine their satisfaction with each of the airway devices. Endoscopist used the following satisfaction scale for each patient, regardless of the airway device used: 1. The airway device did not interfere at all with the ability to perform the scope. 2. The airway device presented some interference with the scope, but not enough to cause difficulty. 3. The airway device made it difficult to perform the endoscopy. 4. The airway device prevented the endoscopy from being performed.

Outcome measures

Outcome measures
Measure	Largyngeal Mask Airway for EGD Procedure n=42 Participants Patients randomized to LMA to maintain airway through EGD procedure LMA: Patients randomized to the LMA group had their airways maintained with a LMA device	Endotracheal Tube for EGD Procedure n=42 Participants Patients were randomized to ETT to maintain airway for EGD procedure. This is the standard of care at this hospital ETT: Patients assigned to this group had an ETT placed to maintain their airway, as is standard of care at this hospital
Endoscopist Satisfaction	1.0 units on a scale Standard Deviation 0.0	1.1 units on a scale Standard Deviation 0.3

SECONDARY outcome

Timeframe: OR to discharge

Overall time from arrival in the OR to discharge home (in minutes)

Outcome measures

Outcome measures
Measure	Largyngeal Mask Airway for EGD Procedure n=42 Participants Patients randomized to LMA to maintain airway through EGD procedure LMA: Patients randomized to the LMA group had their airways maintained with a LMA device	Endotracheal Tube for EGD Procedure n=42 Participants Patients were randomized to ETT to maintain airway for EGD procedure. This is the standard of care at this hospital ETT: Patients assigned to this group had an ETT placed to maintain their airway, as is standard of care at this hospital
OR to Discharge (Min)	86.6 Minutes Standard Deviation 18.5	102.5 Minutes Standard Deviation 40.4

Adverse Events

LMA Used to Maintain Airway

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

ETT Used to Maintain Airway

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	LMA Used to Maintain Airway n=42 participants at risk Patients randomized to LMA to maintain airway through EGD procedure	ETT Used to Maintain Airway n=42 participants at risk Patients were randomized to ETT to maintain airway for EGD procedure. This is the standard of care at this hospital
Respiratory, thoracic and mediastinal disorders laryngospasm	0.00% 0/42	4.8% 2/42
Respiratory, thoracic and mediastinal disorders asthma exacerbation postop	0.00% 0/42	2.4% 1/42

Additional Information

Nicole Horn, MD

IndianaU

Phone: 3179449981

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place