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

Intubation;Difficult Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03929445
• Other study ID #: Ghada
• Status: Completed
• Phase: N/A
• Start date: January 2017
• Est. completion date: November 2018

Study information

• Verified date: March 2019
• Source: Suez Canal University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: November 2018
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Endotracheal Tube Wrongly Placed During Anesthetic Procedure
• Intubation;Difficult

Intervention

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.

Locations

Country	Name	City	State
Egypt	Ghada A.Kamhawy	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Suez Canal University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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