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Evaluation of the Rapid Airway Management Positioner (RAMP)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Carin A. Hagberg, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:
NCT00581230
First received: December 20, 2007
Last updated: August 11, 2016
Last verified: August 2016
Results First Received: April 12, 2011  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Endotracheal Intubation
Rapid Airway Management Positioner
Interventions: Device: Laryngoscopy with RAMP
Device: Laryngoscopy without RAMP

  Participant Flow
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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
  Description
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  
STARTED     51  
Laryngoscopy Without RAMP     51  
Laryngoscopy With RAMP     51  
COMPLETED     51  
NOT COMPLETED     0  



  Baseline Characteristics
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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
  Description
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  
Number of Participants  
[units: participants]
  51  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     50  
>=65 years     1  
Age  
[units: years]
Mean (Standard Deviation)
  42.76  (10.94)  
Gender  
[units: participants]
 
Female     41  
Male     10  
Region of Enrollment  
[units: participants]
 
United States     51  



  Outcome Measures
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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
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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
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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
e-mail: carin.a.hagberg@uth.tmc.edu



Responsible Party: Carin A. Hagberg, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT00581230     History of Changes
Other Study ID Numbers: HSC-MS-07-0067
Study First Received: December 20, 2007
Results First Received: April 12, 2011
Last Updated: August 11, 2016
Health Authority: United States: Institutional Review Board