Evaluation of the Rapid Airway Management Positioner

NCT00581230 | Completed Results

• 1 other identifier: HSC-MS-07-0067
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Endotracheal Intubation; Rapid Airway Management Positioner

Keywords

Endotracheal Intubation; Rapid Airway Management Positioner

Outcome Measures

Primary Outcomes (2)

• Ease of Mask Ventilation as Assessed by Han Class

  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

  Time before intubation

• Glottic View as Assessed by the Cormack and Lehane Classification

  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

  before intubation

Study Arms (2)

Laryngoscopy without RAMP

EXPERIMENTAL

First, laryngoscopy will be preformed utilizing a traditional Macintosh size 4 blade laryngoscope. The view of the laryngeal aperture will be recorded, and a photo will be taken by the Airway Cam™.

Device: Laryngoscopy without RAMP

Laryngoscopy with RAMP

EXPERIMENTAL

Next, the Rapid Airway Management Positioner (RAMP) will be positioned and inflated underneath the patient so that the patient is placed in the optimal sniffing position. The investigator will again perform laryngoscopy utilizing the same technique and the laryngeal view will be recorded.

Device: Laryngoscopy with RAMP

Interventions

Laryngoscopy with RAMP DEVICE

inflatable positioning ramp

Laryngoscopy with RAMP

Laryngoscopy without RAMP DEVICE

Laryngoscopy without RAMP

Laryngoscopy without RAMP

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

Memorial Hermann Hospital

Houston, Texas, 77030, United States

Location

MeSH Terms

Interventions

Laryngoscopy

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Respiratory System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Otorhinolaryngologic Surgical Procedures

Limitations and Caveats

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.

Results Point of Contact

• Title: Carin A. Hagberg
• Organization: UT Medical School at Houston

carin.a.hagberg@uth.tmc.edu

713-500-6222

Study Officials

• Carin A. Hagberg,, M.D.

  The University of Texas Medical School at Houston

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chair - Anesthesiology

Study Record Dates

• First Submitted: December 20, 2007
• First Posted: December 27, 2007
• Study Start: December 1, 2007
• Primary Completion: July 1, 2008
• Study Completion: July 1, 2008
• Last Updated: September 20, 2016
• Results First Posted: April 25, 2016

Record last verified: 2016-08

Locations

US (1)