Trial Outcomes & Findings for Clinical Comparison of the Airway Devices (NCT NCT00581386)

Results Overview

The time taken to successfully place the device in seconds.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

218 participants

Primary outcome timeframe

duration of intubation

Results posted on

2016-09-20

Participant Flow

Patients were recruited from the Memorial Hermann Hospital between 05/30/2007 and 04/15/2009. The patients enrolled were undergoing general anesthesia.

There were no enrolled participants excluded from trial before assignment to groups.

Participant milestones

Participant milestones
Measure	Disposable Laryngeal Tube Suction (LTS-D) Patients were randomly distributed into this group. The patients assigned to this group were intubated using a new LMA device the LTS-D.	Esophageal Tracheal Combitube(ETC) Patients were randomly assigned into this group. The patients assisgned to this group were intubated with the device ETC.	ProSeal Laryngeal Mask Airway (PLMA) Patients were randomly assigned into this group. The patients in this group were intubated with the device PLMA.
Overall Study STARTED	73	73	72
Overall Study COMPLETED	73	73	72
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Clinical Comparison of the Airway Devices

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Disposable Laryngeal Tube Suction (LTS-D) n=73 Participants Patients were randomly distributed into this group. The patients assigned to this group were intubated using a new LMA device the LTS-D.	Esophageal Tracheal Combitube(ETC) n=73 Participants Patients were randomly assigned into this group. The patients assisgned to this group were intubated with the device ETC.	ProSeal Laryngeal Mask Airway (PLMA) n=72 Participants Patients were randomly assigned into this group. The patients in this group were intubated with the device PLMA.	Total n=218 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	73 Participants n=5 Participants	73 Participants n=7 Participants	72 Participants n=5 Participants	218 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Continuous	41.84 years STANDARD_DEVIATION 14.95 • n=5 Participants	39.45 years STANDARD_DEVIATION 13.73 • n=7 Participants	40.08 years STANDARD_DEVIATION 13.68 • n=5 Participants	40.47 years STANDARD_DEVIATION 14.12 • n=4 Participants
Sex: Female, Male Female	23 Participants n=5 Participants	23 Participants n=7 Participants	17 Participants n=5 Participants	63 Participants n=4 Participants
Sex: Female, Male Male	50 Participants n=5 Participants	50 Participants n=7 Participants	55 Participants n=5 Participants	155 Participants n=4 Participants
Region of Enrollment United States	73 participants n=5 Participants	73 participants n=7 Participants	72 participants n=5 Participants	218 participants n=4 Participants

PRIMARY outcome

Timeframe: duration of intubation

The time taken to successfully place the device in seconds.

Outcome measures

Outcome measures
Measure	Disposable Laryngeal Tube Suction (LTS-D) n=73 Participants Patients were randomly distributed into this group. The patients assigned to this group were intubated using a new LMA device the LTS-D.	Esophageal Tracheal Combitube(ETC) n=73 Participants Patients were randomly assigned into this group. The patients assisgned to this group were intubated with the device ETC.	ProSeal Laryngeal Mask Airway (PLMA) n=72 Participants Patients were randomly assigned into this group. The patients in this group were intubated with the device PLMA.
Duration of Intubation	30.9 seconds Standard Deviation 18.7	30.8 seconds Standard Deviation 23.3	30.17 seconds Standard Deviation 31.53

PRIMARY outcome

Timeframe: Time taken for successful placement

Population: As per protocol,of all the patients intubated with the assigned specific device number of patients in whom the device was placed successfully in the first attempt.

The number of patients in whom the assigned device was successfully placed in the first attempt as per protocol.

Outcome measures

Outcome measures
Measure	Disposable Laryngeal Tube Suction (LTS-D) n=73 Participants Patients were randomly distributed into this group. The patients assigned to this group were intubated using a new LMA device the LTS-D.	Esophageal Tracheal Combitube(ETC) n=73 Participants Patients were randomly assigned into this group. The patients assisgned to this group were intubated with the device ETC.	ProSeal Laryngeal Mask Airway (PLMA) n=72 Participants Patients were randomly assigned into this group. The patients in this group were intubated with the device PLMA.
Number of Participants With a Successful First Attempt Placement	65 Participants	49 Participants	52 Participants

PRIMARY outcome

Timeframe: Time taken for intubation

Population: As per protocol,the number of cases in whom the device could not be placed successfully in first attempt and required 2nd and 3rd attempts.

The number of repeated attempts required for successfully placing the device. Each device was given a chance of 3 attempts if still unsuccessful after 3 attempts another device was placed.

Outcome measures

Outcome measures
Measure	Disposable Laryngeal Tube Suction (LTS-D) n=73 Participants Patients were randomly distributed into this group. The patients assigned to this group were intubated using a new LMA device the LTS-D.	Esophageal Tracheal Combitube(ETC) n=73 Participants Patients were randomly assigned into this group. The patients assisgned to this group were intubated with the device ETC.	ProSeal Laryngeal Mask Airway (PLMA) n=72 Participants Patients were randomly assigned into this group. The patients in this group were intubated with the device PLMA.
Number of Patients Who Required Multiple Attempts.	8 Participants	24 Participants	20 Participants

PRIMARY outcome

Timeframe: Duration of surgery

The maximum leak pressure attained for each device.

Outcome measures

Outcome measures
Measure	Disposable Laryngeal Tube Suction (LTS-D) n=73 Participants Patients were randomly distributed into this group. The patients assigned to this group were intubated using a new LMA device the LTS-D.	Esophageal Tracheal Combitube(ETC) n=73 Participants Patients were randomly assigned into this group. The patients assisgned to this group were intubated with the device ETC.	ProSeal Laryngeal Mask Airway (PLMA) n=72 Participants Patients were randomly assigned into this group. The patients in this group were intubated with the device PLMA.
Leak Pressures	25.9 cm of H2O Standard Deviation 4.6	23.5 cm of H2O Standard Deviation 5.3	24.4 cm of H2O Standard Deviation 5.09

PRIMARY outcome

Timeframe: 2 hrs and 24 hrs after surgery

Population: As per protocol,all the patients were followed up at 2 hrs and 24hrs to check for any postoperative hoarseness, sorethroat and difficulty swallowing. The numbers represent the number of patients who complained of postoperative morbidity.

We followed the patients 2 and 24 hours after the surgery for sore throat, hoarseness and dysphagia.The numbers represented here are the number of patients who reported sore throat at 2 hrs and after 24 hrs as per the protocol.

Outcome measures

Outcome measures
Measure	Disposable Laryngeal Tube Suction (LTS-D) n=73 Participants Patients were randomly distributed into this group. The patients assigned to this group were intubated using a new LMA device the LTS-D.	Esophageal Tracheal Combitube(ETC) n=73 Participants Patients were randomly assigned into this group. The patients assisgned to this group were intubated with the device ETC.	ProSeal Laryngeal Mask Airway (PLMA) n=72 Participants Patients were randomly assigned into this group. The patients in this group were intubated with the device PLMA.
Post Operative Morbidity	10 participants	39 participants	5 participants

PRIMARY outcome

Timeframe: Time taken for successful intubation

Population: As per protocol, a case is decided as a failed case when the patient was not able to be intubated with the assigned device after 3 attempts.

We calculated the number of failed cases. As per protocol, that is number of patients in whom successful intubation was not achieved with the assigned device after 3 attempts.

Outcome measures

Outcome measures
Measure	Disposable Laryngeal Tube Suction (LTS-D) n=73 Participants Patients were randomly distributed into this group. The patients assigned to this group were intubated using a new LMA device the LTS-D.	Esophageal Tracheal Combitube(ETC) n=73 Participants Patients were randomly assigned into this group. The patients assisgned to this group were intubated with the device ETC.	ProSeal Laryngeal Mask Airway (PLMA) n=72 Participants Patients were randomly assigned into this group. The patients in this group were intubated with the device PLMA.
Number of Failed Cases	4 Participants	9 Participants	5 Participants

Adverse Events

Disposable Laryngeal Tube Suction (LTS-D)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Esophageal Tracheal Combitube(ETC)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

ProSeal Laryngeal Mask Airway (PLMA)

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

Dr. Carin A. Hagberg

UTHSC- Houston Medical School

Phone: 713.500.6222

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place