Trial Outcomes & Findings for Comparison of I-gel to the Laryngeal Mask Airway (NCT NCT00706823)

Results Overview

The total time to intubation was measured from the beginning of supraglottic airway device (SGA) insertion to successful endotracheal tube intubation, verified by detection of CO2 on the capnogram (anesthesia machine).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

50 participants

Primary outcome timeframe

duration of intubation

Results posted on

2017-02-20

Participant Flow

The patients for this study have been recruited from Feb 2008 through July 2008. The patients were recruited from the day surgery and holding areas.

Participant milestones

Participant milestones
Measure	I-gel-SGA Patients who received i-gel for intubation. The i-gel is a disposable, cuffless, single-use supraglottic airway device used for airway management. It is similar to the uLMA with the addition of a gastric drain. The i-gel is made of a gel-like thermoplastic elastomer, has an anatomically-designed mask that allows quick and easy insertion, and can accurately position itself over the laryngeal framework to provide a reliable perilaryngeal seal without the need for an inflatable cuff.	LMA-Unique Patients who received LMA Unique (uLMA) for intubation. The uLMA is a disposable, inflatable supraglottic airway device that is based on the LMA Classic design, which has been used as the "model" in the industry. It has been listed as a commonly accepted device for routine and rescue airway management and is now listed in the American Society of Anesthesiologists (ASA) Difficult Airway Management Algorithm as an airway conduit for tracheal intubation.
Overall Study STARTED	25	25
Overall Study COMPLETED	25	25
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Comparison of I-gel to the Laryngeal Mask Airway

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	I-gel-SGA n=25 Participants Patients who received i-gel SGA for intubation	LMA-Unique n=25 Participants Patients who received LMA-Unique for intubation	Total n=50 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	25 Participants n=5 Participants	23 Participants n=7 Participants	48 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Age, Continuous	38.2 years STANDARD_DEVIATION 10.5 • n=5 Participants	35.3 years STANDARD_DEVIATION 16.6 • n=7 Participants	37.28 years STANDARD_DEVIATION 13.8 • n=5 Participants
Gender Female	9 Participants n=5 Participants	6 Participants n=7 Participants	15 Participants n=5 Participants
Gender Male	16 Participants n=5 Participants	19 Participants n=7 Participants	35 Participants n=5 Participants
Region of Enrollment United States	25 participants n=5 Participants	25 participants n=7 Participants	50 participants n=5 Participants

PRIMARY outcome

Timeframe: duration of intubation

The total time to intubation was measured from the beginning of supraglottic airway device (SGA) insertion to successful endotracheal tube intubation, verified by detection of CO2 on the capnogram (anesthesia machine).

Outcome measures

Outcome measures
Measure	I-gel-SGA n=25 Participants Patients who received i-gel for intubation. The i-gel is a disposable, cuffless, single-use supraglottic airway device used for airway management. It is similar to the uLMA with the addition of a gastric drain. The i-gel is made of a gel-like thermoplastic elastomer, has an anatomically-designed mask that allows quick and easy insertion, and can accurately position itself over the laryngeal framework to provide a reliable perilaryngeal seal without the need for an inflatable cuff.	LMA-Unique n=25 Participants Patients who received LMA Unique (uLMA) for intubation. The uLMA is a disposable, inflatable supraglottic airway device that is based on the LMA Classic design, which has been used as the "model" in the industry. It has been listed as a commonly accepted device for routine and rescue airway management and is now listed in the American Society of Anesthesiologists (ASA) Difficult Airway Management Algorithm as an airway conduit for tracheal intubation.
Time Required for Intubation	21.04 seconds Standard Deviation 12.6	30.04 seconds Standard Deviation 14.1

PRIMARY outcome

Timeframe: duration of intubation

After successful placement, airway leak pressure was assessed by closing the circuit to atmosphere and allowing fresh gas flow to build airway pressure. The pressure at which an audible leak was heard was recorded; airway pressure was not permitted to exceed 40 cm H2O.

Outcome measures

Outcome measures
Measure	I-gel-SGA n=25 Participants Patients who received i-gel for intubation. The i-gel is a disposable, cuffless, single-use supraglottic airway device used for airway management. It is similar to the uLMA with the addition of a gastric drain. The i-gel is made of a gel-like thermoplastic elastomer, has an anatomically-designed mask that allows quick and easy insertion, and can accurately position itself over the laryngeal framework to provide a reliable perilaryngeal seal without the need for an inflatable cuff.	LMA-Unique n=25 Participants Patients who received LMA Unique (uLMA) for intubation. The uLMA is a disposable, inflatable supraglottic airway device that is based on the LMA Classic design, which has been used as the "model" in the industry. It has been listed as a commonly accepted device for routine and rescue airway management and is now listed in the American Society of Anesthesiologists (ASA) Difficult Airway Management Algorithm as an airway conduit for tracheal intubation.
Leak Pressure	23.08 cm of H2O Standard Deviation 7.3	20.88 cm of H2O Standard Deviation 4.5

SECONDARY outcome

Timeframe: duration of intubation

Ease of SGA insertion and intubation was subjectively assessed by the operator on a scale from 1 to 5 (1 = very easy, 2 = easy, 3 = neutral, 4 = difficult, 5 = very difficult).

Outcome measures

Outcome measures
Measure	I-gel-SGA n=25 Participants Patients who received i-gel for intubation. The i-gel is a disposable, cuffless, single-use supraglottic airway device used for airway management. It is similar to the uLMA with the addition of a gastric drain. The i-gel is made of a gel-like thermoplastic elastomer, has an anatomically-designed mask that allows quick and easy insertion, and can accurately position itself over the laryngeal framework to provide a reliable perilaryngeal seal without the need for an inflatable cuff.	LMA-Unique n=25 Participants Patients who received LMA Unique (uLMA) for intubation. The uLMA is a disposable, inflatable supraglottic airway device that is based on the LMA Classic design, which has been used as the "model" in the industry. It has been listed as a commonly accepted device for routine and rescue airway management and is now listed in the American Society of Anesthesiologists (ASA) Difficult Airway Management Algorithm as an airway conduit for tracheal intubation.
Level of Difficulty for Intubation Very Easy	11 participants	8 participants
Level of Difficulty for Intubation Easy	12 participants	17 participants
Level of Difficulty for Intubation Neutral	0 participants	0 participants
Level of Difficulty for Intubation Difficult	2 participants	0 participants
Level of Difficulty for Intubation Very Difficult	0 participants	0 participants

SECONDARY outcome

Timeframe: post operative, immediately and 24 hrs after intubation

Oropharyngeal discomfort was assessed. including sore throat, hoarseness, and dysphagia.

Outcome measures

Outcome measures
Measure	I-gel-SGA n=25 Participants Patients who received i-gel for intubation. The i-gel is a disposable, cuffless, single-use supraglottic airway device used for airway management. It is similar to the uLMA with the addition of a gastric drain. The i-gel is made of a gel-like thermoplastic elastomer, has an anatomically-designed mask that allows quick and easy insertion, and can accurately position itself over the laryngeal framework to provide a reliable perilaryngeal seal without the need for an inflatable cuff.	LMA-Unique n=25 Participants Patients who received LMA Unique (uLMA) for intubation. The uLMA is a disposable, inflatable supraglottic airway device that is based on the LMA Classic design, which has been used as the "model" in the industry. It has been listed as a commonly accepted device for routine and rescue airway management and is now listed in the American Society of Anesthesiologists (ASA) Difficult Airway Management Algorithm as an airway conduit for tracheal intubation.
Number of Participants With Oropharyngeal Discomfort Postop symptoms present	6 participants	10 participants
Number of Participants With Oropharyngeal Discomfort Postop symptoms absent	19 participants	15 participants

SECONDARY outcome

Timeframe: after intubation

Population: Only the -gel has a gastric drainage tube--the uLMA does not. Thus, only those receiving the i-gel were assessed for this measure.

When the fiberoptic scope was placed in the gastirc drain tube of the i-gel, if the esophageal mucosa was visible and the stomach was readily accessible, then placement was considered succussful.

Outcome measures

Outcome measures
Measure	I-gel-SGA n=25 Participants Patients who received i-gel for intubation. The i-gel is a disposable, cuffless, single-use supraglottic airway device used for airway management. It is similar to the uLMA with the addition of a gastric drain. The i-gel is made of a gel-like thermoplastic elastomer, has an anatomically-designed mask that allows quick and easy insertion, and can accurately position itself over the laryngeal framework to provide a reliable perilaryngeal seal without the need for an inflatable cuff.	LMA-Unique Patients who received LMA Unique (uLMA) for intubation. The uLMA is a disposable, inflatable supraglottic airway device that is based on the LMA Classic design, which has been used as the "model" in the industry. It has been listed as a commonly accepted device for routine and rescue airway management and is now listed in the American Society of Anesthesiologists (ASA) Difficult Airway Management Algorithm as an airway conduit for tracheal intubation.
Number of Participants With Successful Gastric Drainage Tube Placement as Assessed by Fiberoptic Scope Visualization Esophageal mucosa visible and stomach accessible	22 participants	—
Number of Participants With Successful Gastric Drainage Tube Placement as Assessed by Fiberoptic Scope Visualization Upper esophageal sphincter visible	2 participants	—
Number of Participants With Successful Gastric Drainage Tube Placement as Assessed by Fiberoptic Scope Visualization Glottis visible	1 participants	—

SECONDARY outcome

Timeframe: Before intubation

The number of attempts taken to place the device

Outcome measures

Outcome measures
Measure	I-gel-SGA n=25 Participants Patients who received i-gel for intubation. The i-gel is a disposable, cuffless, single-use supraglottic airway device used for airway management. It is similar to the uLMA with the addition of a gastric drain. The i-gel is made of a gel-like thermoplastic elastomer, has an anatomically-designed mask that allows quick and easy insertion, and can accurately position itself over the laryngeal framework to provide a reliable perilaryngeal seal without the need for an inflatable cuff.	LMA-Unique n=25 Participants Patients who received LMA Unique (uLMA) for intubation. The uLMA is a disposable, inflatable supraglottic airway device that is based on the LMA Classic design, which has been used as the "model" in the industry. It has been listed as a commonly accepted device for routine and rescue airway management and is now listed in the American Society of Anesthesiologists (ASA) Difficult Airway Management Algorithm as an airway conduit for tracheal intubation.
Number of Attempts 1 attempt	17 participants	21 participants
Number of Attempts 2 attempts	7 participants	3 participants
Number of Attempts 3 attempts	1 participants	1 participants

Adverse Events

I-gel-SGA

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

LMA-Unique

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	I-gel-SGA n=25 participants at risk Patients who received i-gel for intubation. The i-gel is a disposable, cuffless, single-use supraglottic airway device used for airway management. It is similar to the uLMA with the addition of a gastric drain. The i-gel is made of a gel-like thermoplastic elastomer, has an anatomically-designed mask that allows quick and easy insertion, and can accurately position itself over the laryngeal framework to provide a reliable perilaryngeal seal without the need for an inflatable cuff.	LMA-Unique n=25 participants at risk Patients who received LMA Unique (uLMA) for intubation. The uLMA is a disposable, inflatable supraglottic airway device that is based on the LMA Classic design, which has been used as the "model" in the industry. It has been listed as a commonly accepted device for routine and rescue airway management and is now listed in the American Society of Anesthesiologists (ASA) Difficult Airway Management Algorithm as an airway conduit for tracheal intubation.
Surgical and medical procedures Oropharyngeal discomfort	24.0% 6/25 • Number of events 25 • Postoperatively, within 2 hours of emergence and extubation	40.0% 10/25 • Number of events 25 • Postoperatively, within 2 hours of emergence and extubation

Additional Information

Carin A. Hagberg, MD

University of Texas Medical School at Houston

Phone: 713-500-6222

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place