Endotracheal Intubation Using a Bougie Through the Air-Q Intubating Laryngeal Airway

NCT02322684 | Completed

• 1 other identifier: TBRI-airq
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the success rate of bougie-guided endotracheal intubation compared to blind intubation through the Air-Q intubating laryngeal mask

Conditions

Airway Complication of Anaesthesia

Keywords

Bougie; Air-Q; Insertion

Outcome Measures

Primary Outcomes (1)

• Assess bougie-guided tracheal tube placement through the air-Q® Intubating Laryngeal Airway regarding success rate on the first attempt

  The operator gently inserts the bougie through the air-Q/ILA while looking at any bulges in the neck to judge the approximate positioning of the bougie. As soon as the bougie enters the trachea, a characteristic click is felt by the assistant and the operator feels the bougie entering in a hallow space. Another sign for intra tracheal bougie insertion when the bougie reaches the small bronchus between 30 and 40 cm marks (distal hold up sign). The air-Q/ILA is then removed and a tracheal tube is railroaded over the bougie.

  Three attempts are allowed (up to 5 minutes)

Secondary Outcomes (2)

• The overall success rate

  5 minutes

• The tracheal intubation time

  1 minute

Other Outcomes (2)

• The number of attempts

  5 minutes

• Complications (Sore throat, dysphagia, dysphonia and its degree (mild/moderate/severe)

  24 hours

Study Arms (2)

Group Q

ACTIVE COMPARATOR

Blind endotracheal intubation will be performed through the air-Q

Device: Air-Q

Group B

ACTIVE COMPARATOR

Blind endotracheal intubation will be performed through the air-Q with bougie assisted

Device: Air-Q

Interventions

Air-Q DEVICE

Air-Q/Intubating Laryngeal Airway (air-Q/ILA, Cookgas LLC, St. Louis, MO, USA) is an extra glottis airway (EGA) used as a primary airway device or as an adjunct to tracheal intubation. The air-Q/ILA is available as a disposable (air-Q) or nondisposable (ILA) device

Also known as: Intubating laryngeal Airway

Group B; Group Q

Eligibility Criteria

• Age: 19 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• years old,
• ASA physical status I and II
• Patients scheduled to receive general anesthesia with tracheal intubation for an elective surgical procedure.

You may not qualify if:

• Age \<19 \& \>60
• ASA physical status ≥ III,
• Mouth opening \<2 cm,
• Patients with increased risk of aspiration,
• Those with poor lung compliance,
• Patients with lesions of the oropharynx or epiglottis
• Patients known or anticipated to have difficult tracheal intubation or facemask ventilation.

Sponsors & Collaborators

• Theodor Bilharz Research Institute: lead

Study Sites (1)

Theodor Bilharz Research Institute

Giza, 12411, Egypt

Location

Related Links

• Theodor Bilharz Research Institute

Study Officials

• Reeham S. Ebied, M.D.

  Theodor Bilharz Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 15, 2014
• First Posted: December 23, 2014
• Study Start: January 1, 2015
• Primary Completion: June 1, 2016
• Study Completion: July 1, 2016
• Last Updated: October 19, 2016

Record last verified: 2016-10

Locations

EG (1)