Comparison of I-gel to the Laryngeal Mask Airway

NCT00706823 | Completed Results

• 1 other identifier: HSC-MS-08-0004
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate a new disposable supra-glottic airway device, the i-gel airway (Intersurgical Ltd., Wokingham, England). We propose to test its ease of insertion, position within the airway, drain tube patency and anatomic sealing properties during mechanical ventilation in non-obese anesthetized patients undergoing elective general surgery. The study device will be compared to the current standard in the industry, the LMA Unique.

Conditions

Endotracheal Intubation; Supraglottic Airway

Keywords

Endotracheal Intubation; Supraglottic Airway

Outcome Measures

Primary Outcomes (2)

• Time Required for Intubation

  The total time to intubation was measured from the beginning of supraglottic airway device (SGA) insertion to successful endotracheal tube intubation, verified by detection of CO2 on the capnogram (anesthesia machine).

  duration of intubation

• Leak Pressure

  After successful placement, airway leak pressure was assessed by closing the circuit to atmosphere and allowing fresh gas flow to build airway pressure. The pressure at which an audible leak was heard was recorded; airway pressure was not permitted to exceed 40 cm H2O.

  duration of intubation

Secondary Outcomes (4)

• Level of Difficulty for Intubation

  duration of intubation

• Number of Participants With Oropharyngeal Discomfort

  post operative, immediately and 24 hrs after intubation

• Number of Participants With Successful Gastric Drainage Tube Placement as Assessed by Fiberoptic Scope Visualization

  after intubation

• Number of Attempts

  Before intubation

Study Arms (2)

i-gel-SGA

EXPERIMENTAL

Patients who received i-gel supraglottic device (i-gel airway) for intubation

Device: i-gel airway (Intersurgical Ltd., Wokingham, England)

LMA-Unique

ACTIVE COMPARATOR

Patients who received the Laryngeal Mask Airway-Unique (uLMA) for intubation

Device: Laryngeal Mask Airway-Unique

Interventions

i-gel airway (Intersurgical Ltd., Wokingham, England) DEVICE

supra-glottic airway device

i-gel-SGA

Laryngeal Mask Airway-Unique DEVICE

supra-glottic airway device

LMA-Unique

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The subjects will be adult surgical candidates aged 18-80, ASA I-II, Mallampati I or II, presenting for elective surgery who require general anesthesia in whom tracheal intubation is not necessary.
• Both male and female patients will be included.

You may not qualify if:

• Patients will be excluded from the study if they present as Mallampati III or IV, ASA III-V or emergency status. Additionally, they will be excluded if they meet one of the contraindication criteria of the LMA including:
• obesity, (BMI \> 35 kg/m2)
• pregnancy
• history of gastric regurgitation, heart burn, ileus or "full stomach"
• history of low pulmonary compliance or high pulmonary resistance
• known history of difficult endotracheal intubation or signs suggesting the possibility of difficult intubation
• pharyngeal pathology
• upper airway obstruction due to laryngeal pathology

Sponsors & Collaborators

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

Study Sites (1)

Memorial Hermann Hospital

Houston, Texas, 77030, United States

Location

Results Point of Contact

• Title: Carin A. Hagberg, MD
• Organization: University of Texas 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: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: ◦Professor and Chairman, Joseph C. Gable, MD Endowed Chair

Study Record Dates

• First Submitted: June 24, 2008
• First Posted: June 30, 2008
• Study Start: February 1, 2008
• Primary Completion: August 1, 2008
• Study Completion: August 1, 2008
• Last Updated: February 20, 2017
• Results First Posted: April 5, 2011

Record last verified: 2017-01

Locations

US (1)