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Evaluation of the Rapid Airway Management Positioner (RAMP)

This study has been completed.
Sponsor:
Information provided by:
The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:
NCT00581230
First received: December 20, 2007
Last updated: July 25, 2008
Last verified: July 2008

December 20, 2007
July 25, 2008
December 2007
July 2008   (final data collection date for primary outcome measure)
  • Time and number of attempts required; [ Time Frame: duration of intubation ] [ Designated as safety issue: No ]
  • Level of difficulty for intubation [ Time Frame: duration of intubation ] [ Designated as safety issue: No ]
  • Degree of irritation of the pharynx, epiglottis, and arytenoids [ Time Frame: post operative, immediately and 24 hours later ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00581230 on ClinicalTrials.gov Archive Site
vital signs, oxygen saturation, end-tidal carbon dioxide [ Time Frame: duration of intubation ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Evaluation of the Rapid Airway Management Positioner
An Evaluation Of The Rapid Airway Management Positioner (RAMP) In Obese Patients Undergoing Gastric Bypass Or Laparoscopic Gastric Banding (Lap-Band) Surgery

The purpose of this study is to determine if the Rapid Airway Management Positioner (RAMP, AirPal, Center Valley, PA) is a useful positioning device for direct laryngoscopy and tracheal intubation in obese patients undergoing gastric bypass or laparoscopic gastric banding surgery.

The cannot intubate, cannot ventilate case is the most dangerous of situations, and being able to foresee, prevent, and prepare for such difficulties is the task of every anesthesiologist. Difficult mask ventilation is predicted by a number of factors, including obesity.1 Appropriate bag-and-mask ventilation necessitates a patent airway. An increased BMI is associated with a reduced posterior airway space behind the tongue's base as well as a quick development of hypoxemia from reduced functional residual capacity in improper mask ventilation.1 Proper head and neck positioning to establish the patent airway then is especially important.

There is an increased risk of difficult laryngoscopy among obese patients compared with subjects with normal body mass index.2,3 Optimal laryngeal view during laryngoscopy can be facilitated with proper head and neck positioning, including slight elevation of the head, neck flexion relative to the chest, and extreme atlanto-occipital extension.4 The "ramped" position, where the patient's ear is horizontally aligned with their sternal notch, has been found to be superior to the standard "sniffing" position, 7-cm occiput elevation, during direct laryngoscopy in morbidly obese patients.4

Additionally, there are increased difficulties and risks for tracheal intubation in obese patients versus normal-weight patients. Studies have found that chances for a successful first attempt at oral intubation decrease as patient weight increases.6,7 Improving visualization of laryngeal structures will increase the likelihood of successful tracheal intubation, as increasing the percentage of glottic opening is correlated with the number of intubation attempts, as well as the need for rescue intubation devices.8

It is estimated that endotracheal intubation is performed on approximately 8 million patients per year in the United States. Of these endotracheal intubations, approximately 80% are performed by direct laryngoscopy with transoral placement of the endotracheal tube (ET) into the trachea. There is fairly uniform reporting of the incidence of failed intubation in the literature; it occurs in approximately 0.05% or 1:2230 of surgical patients and in approximately 0.13% to 0.35%, or 1:750 to 1:280, of the obstetric patients.9,10 The incidence of unsuspected difficult intubation is estimated to be higher at 3%. One factor that contributes to difficult intubation is poor visualization, and difficult laryngoscopy is highly correlated with poor laryngeal exposure.11

The Rapid Airway Management Positioner (RAMP) is designed to optimize visualization during direct laryngoscopy by placing the patient into the proper head-elevated laryngoscopy position (HELP). In morbidly obese patients, achieving this position is important,12 and requires a great deal of support under the head and shoulders that could not be performed singlehandedly.13 The RAMP is an easy-to-use, quick device, taking an average of 56 seconds to place and inflate.14

The RAMP has great potential in obese patients. Pre-positioning also helps increase the desaturation safety period for morbidly obese patients.15 Rescue ventilation techniques are facilitated by the HELP position, when the head and neck are elevated above the chest and abdomen. The airway is therefore more isolated and easier to work with, and less positive airway pressure is needed when the weight of the abdomen is away from the diaphragm. Currently, placing a patient on top of stacked blankets is common and can create the HELP, or "ramped" position, 5 but also causes variable and unstable results. We suspect that by providing a better laryngeal view, the RAMP may help decrease the incidence of tissue trauma associated with intubation, and intubation may be achieved more quickly in a population that is known to be difficult.

Interventional
Not Provided
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Intubation
  • Endotracheal
Device: Rapid Airway Management Positioner
inflatable positioning ramp
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
July 2008
July 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • The 50 subjects will be adult surgical candidates age 18-80, ASA I-III, BMI > 30 kg/m2 presenting for gastric bypass or laparoscopic gastric banding surgery who require general anesthesia.

Exclusion Criteria:

  • Patients will be excluded if it is determined that an awake intubation should be performed. Mallampati IV and ASA IV-V patients will also be excluded, as well as patients with unstable cervical, thoracic and/or lumbar fracture.
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00581230
HSC-MS-07-0067
No
Carin Hagberg, M.D./ Professor and Vice Chair, The University of Texas Health Science Center, Houston
The University of Texas Health Science Center, Houston
Not Provided
Principal Investigator: Carin A. Hagberg,, M.D. The University of Texas Medical School at Houston
The University of Texas Health Science Center, Houston
July 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP