Evaluation of the Rapid Airway Management Positioner (RAMP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00581230
Recruitment Status : Completed
First Posted : December 27, 2007
Results First Posted : April 25, 2016
Last Update Posted : September 20, 2016
Information provided by (Responsible Party):
Carin A. Hagberg, The University of Texas Health Science Center, Houston

Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Endotracheal Intubation
Rapid Airway Management Positioner
Interventions: Device: Laryngoscopy with RAMP
Device: Laryngoscopy without RAMP

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The patients who presented to surgery and met inclusion criteria were enrolled in the study

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
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.

Participant Flow:   Overall Study
    Entire Study
Laryngoscopy Without RAMP   51 
Laryngoscopy With RAMP   51 

  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
Laryngoscopy Without RAMP, Then Laryngoscopy With RAMP 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.

Baseline Measures
   Laryngoscopy Without RAMP, Then Laryngoscopy With RAMP 
Overall Participants Analyzed 
[Units: Participants]
[Units: Participants]
<=18 years   0 
Between 18 and 65 years   50 
>=65 years   1 
[Units: Years]
Mean (Standard Deviation)
 42.76  (10.94) 
[Units: Participants]
Female   41 
Male   10 
Region of Enrollment 
[Units: Participants]
United States   51 

  Outcome Measures

1.  Primary:   Ease of Mask Ventilation as Assessed by Han Class   [ Time Frame: Time before intubation ]

2.  Primary:   Glottic View as Assessed by the Cormack and Lehane Classification   [ Time Frame: before intubation ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
major limitations of the study was the lack of a blinded observer for the purpose of rating the laryngoscopic view & how easily, quickly & consistently this position can be achieved as well as to return the patient to a neutral position for surgery.

  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact:  
Name/Title: Carin A. Hagberg
Organization: UT Medical School at Houston
phone: 713-500-6222

Responsible Party: Carin A. Hagberg, The University of Texas Health Science Center, Houston Identifier: NCT00581230     History of Changes
Other Study ID Numbers: HSC-MS-07-0067
First Submitted: December 20, 2007
First Posted: December 27, 2007
Results First Submitted: April 12, 2011
Results First Posted: April 25, 2016
Last Update Posted: September 20, 2016