Ambu® Laryngeal Mask as an Intubation Conduit

NCT00272194 | Completed Phase 4

• 1 other identifier: HSC-MS-05-0347
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine if the Ambu Laryngeal Mask can be used as an intubation conduit for endotracheal intubation.

Conditions

Intubation, Endotracheal

Keywords

Endotracheal Intubation; Supraglottic Airway

Outcome Measures

Primary Outcomes (1)

• Time and number of attempts required; Level of difficulty; Degree of irritation of the pharynx, epiglottis, and arytenoids

Secondary Outcomes (1)

• vital signs, oxygen saturation, end-tidal carbon dioxide

Interventions

Ambu Laryngeal Mask DEVICE

Aintree Exchange Catheter DEVICE

Laryngeal Mask Airway DEVICE

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 patient is ASA 1-3 presenting for an elective surgical procedure
• The patient is 18-65 years of age
• The patient weighs \> 50 kg with a BMI \< 30 kg/m2
• The patient has a Mallampati grade I -III airway
• The patient is undergoing general anesthesia with controlled ventilation for minor routine surgical procedures
• The period of anesthesia time is \>30 minutes

You may not qualify if:

• The patient is an ASA classification 4
• The patient is \< 18 or \>65 years of age
• The patient weighs \< 50 kg or has a BMI \> 30 kg/m2
• The patient has a history of inadequate cervical mobility
• The patient has a history or signs of difficult airway management
• The patient has a Mallampati grade IV Class airway
• The patient has a mouth opening \< 2.5 cm
• The patient has an oral cavity disease
• The patient has a cervical malformation
• The patient had upper respiratory tract symptoms in the previous 10 days
• The patient is to have surgery performed to the head/neck or thoracoabdominal cavities needing to be paralyzed, or in the lateral/prone position
• The patient is considered at risk of aspiration (non-fasted, gastroesophageal reflux/disease)

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead
• Ambu A/S: collaborator

Study Sites (1)

Memorial Hermann Hospital

Houston, Texas, 77030, United States

Location

MeSH Terms

Interventions

Laryngeal Masks

Intervention Hierarchy (Ancestors)

Intubation, Intratracheal; Airway Management; Therapeutics; Intubation; Investigative Techniques; Masks; Protective Devices; Equipment and Supplies; Personal Protective Equipment; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Carin A. Hagberg, M.D.

  The University of Texas Medical School at Houston

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chairman, Joseph C. Gable, M.D., Endowed Chair

Study Record Dates

• First Submitted: January 2, 2006
• First Posted: January 4, 2006
• Study Start: December 1, 2005
• Study Completion: April 1, 2007
• Last Updated: March 23, 2016

Record last verified: 2016-03

Locations

US (1)