Bougie Assisted Endotracheal Intubation in Air-Q Intubating Laryngeal Mask And Fastrach Intubating Laryngeal Mask

Not Applicable

Completed

• Conditions: Intubation;Difficult; Endotracheal Tube Wrongly Placed During Anesthetic Procedure
• Interventions: Device: Endotracheal tube introducers

• Registration Number: NCT03929445
• Lead Sponsor: Suez Canal University

Brief Summary

This study aims to compare using bougie as an assistant for endotracheal intubation through Air-Q and Fastrach intubating laryngeal mask devices when blind intubation fails as attempt to increase its success rate.

Detailed Description

The investigators hypothesis that using bougie with its smaller caliber or lesser size can facilitate intubation and improve success rate when blind intubation through both devices fails.

Study objectives

* To make a comparison between Air-Q intubating laryngeal mask and Fastrach intubating laryngeal mask by using bougie assisted endotracheal intubation through both devices in patients undergoing elective surgeries in Suez Canal Hospitals.

* To assess the first trial success rate, the total success rate, time to tracheal intubation, the number of attempts, hemodynamics and adverse events.

Study Timeline

• Study Start: 2017-01
• Primary Completion: 2017-07
• Study Completion: 2018-11
• Study First Submitted: 2018-11-08
• Status Verified: 2019-03
• Study First Submitted QC: 2019-04-24
• Study First Posted: 2019-04-26
• Last Update Submitted: 2019-04-26
• Last Update Posted: 2019-04-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

Inclusion Criteria

• Patient aged >18 years old.
• Gender both male and female.
• Patients are ASA I (American Society of Anesthesiologists' physical status Grade I) normal healthy patients or ASA II patients with mild systemic disease and no functional limitations

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Exclusion Criteria

• Any disorder of the cardiovascular, pulmonary, hepatic, renal, or gastrointestinal systems known from history or general examination.
• Patients with unstable cervical spine
• Any medical disease that may affect airway as Rheumatoid arthritis.
• Patient refusal to participate in the study.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AIR-Q group	Endotracheal tube introducers	the group which selected randomly to try AIR-Q device
I-LMA group	Endotracheal tube introducers	the group which selected randomly to try I-LMA device

Primary Outcome Measures

Name	Time	Method
success rate of endotracheal intubation on the first, second and third attempts in both devices Air-Q and fastrach	180 seconds after anethesia induction	If the blind intubation is failed through Air Q or Fastrack Intubating laryngeal mask the investigator will use gum elastic bougie to facilitate introducing an endotracheal tube estimation of success rate of endotracheal intubation on the first, second and third attempts
The time needed for devices insertion (Air Q and Fastrach Intubating Laryngeal mask)	!80 seconds after anesthesia induction	1. Air Q and Fastrach Intubating laryngeal mask insertion time in seconds will be measured (device time).; 2. Endotracheal tube (ETT) insertion time will be measured ( ETT time).; 3. Total insertion time will be estimated (Device Time + ETT Time )

Secondary Outcome Measures

Name	Time	Method
Incidence of adverse events	Intraoperative and in the first 48 postoperative hours	Incidence of adverse events and complications during and after the procedure will be also recorded. Complications, including laryngospasm, bleeding, false passage, and sore throat will be recorded intraoperatively and in the first 48 postoperative hours.

Trial Locations

Locations (1)

Ghada A.Kamhawy; 🇪🇬 Cairo, Egypt