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

NCT03929445 | Completed

• 1 other identifier: Ghada
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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.

Conditions

Intubation;Difficult; Endotracheal Tube Wrongly Placed During Anesthetic Procedure

Keywords

Bougie; Air Q; Fastrach

Outcome Measures

Primary Outcomes (2)

• 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)

  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 )

  !80 seconds after anesthesia induction

Secondary Outcomes (1)

• Incidence of adverse events

  Intraoperative and in the first 48 postoperative hours

Study Arms (2)

AIR-Q group

ACTIVE COMPARATOR

the group which selected randomly to try AIR-Q device

Device: Endotracheal tube introducers

I-LMA group

ACTIVE COMPARATOR

the group which selected randomly to try I-LMA device

Device: Endotracheal tube introducers

Interventions

Endotracheal tube introducers DEVICE

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.

Also known as: The Gum Elastic Bougie

AIR-Q group; I-LMA group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Suez Canal University: lead

Study Sites (1)

Ghada A.Kamhawy

Cairo, 12311, Egypt

Location

Study Officials

• Ghada A. Kamhawy, Lecturer

  Suez Canal University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical professor

Study Record Dates

• First Submitted: November 8, 2018
• First Posted: April 26, 2019
• Study Start: January 1, 2017
• Primary Completion: July 1, 2017
• Study Completion: November 1, 2018
• Last Updated: April 30, 2019

Record last verified: 2019-03

Locations

EG (1)