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

A Comparative Study Between Air-Q Intubating Laryngeal Mask And Fastrach Intubating Laryngeal Mask By Using Bougie Assisted Endotracheal Intubation

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.

Study Overview

• Status: Completed
• Conditions: Intubation;Difficult; Endotracheal Tube Wrongly Placed During Anesthetic Procedure
• Intervention / Treatment: Device: Endotracheal tube introducers

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 Type: Interventional
• Enrollment (Actual): 62
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 12311
    • Ghada A.Kamhawy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: AIR-Q group; the group which selected randomly to try AIR-Q device	Device: Endotracheal tube introducers; Endotracheal tube introducers (gum elastic bougie) for emergency intubation The endotracheal tube introducer (ETI) is an effective and inexpensive adjunct to difficult airway management that is easy to use. ETI is solid introducer 60-70 cm long with a 35 - 40 distally angulated (Coude) tip. They are easy to use, widely available, and have been used as adjuncts to difficult direct laryngoscopy for many decades. The gum elastic bougie is usually guided by tactile clicks as the device passes the cartilage rings of the trachea. After Supraglottic devices are removed, an ETT can subsequently be railroaded over the bougie.; Other Names: The Gum Elastic Bougie
ACTIVE_COMPARATOR: I-LMA group; the group which selected randomly to try I-LMA device	Device: Endotracheal tube introducers; Endotracheal tube introducers (gum elastic bougie) for emergency intubation The endotracheal tube introducer (ETI) is an effective and inexpensive adjunct to difficult airway management that is easy to use. ETI is solid introducer 60-70 cm long with a 35 - 40 distally angulated (Coude) tip. They are easy to use, widely available, and have been used as adjuncts to difficult direct laryngoscopy for many decades. The gum elastic bougie is usually guided by tactile clicks as the device passes the cartilage rings of the trachea. After Supraglottic devices are removed, an ETT can subsequently be railroaded over the bougie.; Other Names: The Gum Elastic Bougie

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
success rate of endotracheal intubation on the first, second and third attempts in both devices Air-Q and fastrach	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	180 seconds after anethesia induction
The time needed for devices insertion (Air Q and Fastrach Intubating Laryngeal mask)	Air Q and Fastrach Intubating laryngeal mask insertion time in seconds will be measured (device time).; Endotracheal tube (ETT) insertion time will be measured ( ETT time).; Total insertion time will be estimated (Device Time + ETT Time )	!80 seconds after anesthesia induction

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of adverse events	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.	Intraoperative and in the first 48 postoperative hours

Collaborators and Investigators

• Sponsor: Suez Canal University
• Investigators: Principal Investigator: Ghada A. Kamhawy, Lecturer, Suez Canal University

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2017
• Primary Completion (ACTUAL): July 1, 2017
• Study Completion (ACTUAL): November 1, 2018

Study Registration Dates

• First Submitted: November 8, 2018
• First Submitted That Met QC Criteria: April 24, 2019
• First Posted (ACTUAL): April 26, 2019

Study Record Updates

• Last Update Posted (ACTUAL): April 30, 2019
• Last Update Submitted That Met QC Criteria: April 26, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: Bougie; Fastrach; Air Q
• Other Study ID Numbers: Ghada

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• product manufactured in and exported from the U.S.: No