Trial Outcomes & Findings for Evaluation of the Rapid Airway Management Positioner (NCT NCT00581230)

Results Overview

Grading Scale for Mask Ventilation as described by Han et al. (Anesthesiology. 2004 Jul;101(1):267) Grade 0. Ventilation by mask not attempted Grade 1. Ventilated by mask Grade 2. Ventilated by mask with oral airway/adjuvant with or without muscle relaxant Grade 3. Difficult ventilation (inadequate, unstable, or requiring two providers) with or without muscle relaxant Grade 4. Unable to mask ventilate with or without muscle relaxant

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

51 participants

Primary outcome timeframe

Time before intubation

Results posted on

2016-09-20

Participant Flow

The patients who presented to surgery and met inclusion criteria were enrolled in the study

Participant milestones

Participant milestones
Measure	Entire Study All the patients first underwent mask ventilation and laryngoscopy with Macintosh size 4 blade laryngoscope without RAMP. Second, all patients underwent laryngoscopy with RAMP--the RAMP pillow was inflated for all patients and the ease of Mask ventilation and Cormack Lehane laryngoscopy view with Macintosh size 4 laryngoscope was recorded.
Overall Study STARTED	51
Overall Study Laryngoscopy Without RAMP	51
Overall Study Laryngoscopy With RAMP	51
Overall Study COMPLETED	51
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluation of the Rapid Airway Management Positioner

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Laryngoscopy Without RAMP, Then Laryngoscopy With RAMP n=51 Participants First, laryngoscopy was preformed utilizing a traditional Macintosh size 4 blade laryngoscope (without the Rapid Airway Management Positioner (RAMP)). The view of the laryngeal aperture was recorded, and a photo was taken by the Airway Cam™. Second, the Rapid Airway Management Positioner (RAMP) was positioned and inflated underneath the patient so that the patient was placed in the optimal sniffing position. The investigator again performed laryngoscopy utilizing the same technique, the second time with RAMP, and the laryngeal view was recorded.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	50 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Age, Continuous	42.76 years STANDARD_DEVIATION 10.94 • n=5 Participants
Sex: Female, Male Female	41 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants
Region of Enrollment United States	51 participants n=5 Participants

PRIMARY outcome

Timeframe: Time before intubation

Grading Scale for Mask Ventilation as described by Han et al. (Anesthesiology. 2004 Jul;101(1):267) Grade 0. Ventilation by mask not attempted Grade 1. Ventilated by mask Grade 2. Ventilated by mask with oral airway/adjuvant with or without muscle relaxant Grade 3. Difficult ventilation (inadequate, unstable, or requiring two providers) with or without muscle relaxant Grade 4. Unable to mask ventilate with or without muscle relaxant

Outcome measures

Outcome measures
Measure	Laryngoscopy Without RAMP n=46 Participants In all participants, laryngoscopy was first performed utilizing a traditional Macintosh size 4 blade laryngoscope (without the Rapid Airway Management Postitioner (RAMP)). The view of the laryngeal aperture was recorded, and a photo was taken by the Airway Cam™.	Laryngoscopy With RAMP n=46 Participants In this crossover study, all participants then received laryngoscopy with the Rapid Airway Management Positioner (RAMP) (immediately after Laryngoscopy without RAMP). The RAMP was positioned and inflated underneath the patient so that the patient was placed in the optimal sniffing position. The investigator again performed laryngoscopy utilizing the same technique, except that RAMP was used, and the laryngeal view was recorded.
Ease of Mask Ventilation as Assessed by Han Class Grade 1	15 participants	24 participants
Ease of Mask Ventilation as Assessed by Han Class Grade 2	18 participants	15 participants
Ease of Mask Ventilation as Assessed by Han Class Grade 3	13 participants	7 participants
Ease of Mask Ventilation as Assessed by Han Class Grade 4	0 participants	0 participants

PRIMARY outcome

Timeframe: before intubation

Glottic view as described by Cormack and Lehane (Samsoon GL, Young JR. Difficult tracheal intubation: A retrospective study. Anesthesia 1987; 42:487), scored as follows- Grade 1. Full view of glottis Grade 2a. Partial view of glottis Grade 2b. Arytenoids or posterior portion of cords just visible Grade 3. Only the epiglottis visible Grade 4. Neither epiglottis nor glottis visible

Outcome measures

Outcome measures
Measure	Laryngoscopy Without RAMP n=50 Participants In all participants, laryngoscopy was first performed utilizing a traditional Macintosh size 4 blade laryngoscope (without the Rapid Airway Management Postitioner (RAMP)). The view of the laryngeal aperture was recorded, and a photo was taken by the Airway Cam™.	Laryngoscopy With RAMP n=50 Participants In this crossover study, all participants then received laryngoscopy with the Rapid Airway Management Positioner (RAMP) (immediately after Laryngoscopy without RAMP). The RAMP was positioned and inflated underneath the patient so that the patient was placed in the optimal sniffing position. The investigator again performed laryngoscopy utilizing the same technique, except that RAMP was used, and the laryngeal view was recorded.
Glottic View as Assessed by the Cormack and Lehane Classification Grade 1	17 participants	28 participants
Glottic View as Assessed by the Cormack and Lehane Classification Grade 2a	11 participants	13 participants
Glottic View as Assessed by the Cormack and Lehane Classification Grade 2b	12 participants	6 participants
Glottic View as Assessed by the Cormack and Lehane Classification Grade 3	7 participants	2 participants
Glottic View as Assessed by the Cormack and Lehane Classification Grade 4	3 participants	1 participants

Adverse Events

Entire Study

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

Carin A. Hagberg

UT 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