Endotracheal Tube Threading Over the Fiberoptic Bronchoscope

The Ease of Threading the Endotracheal Tube Over the Fiberoptic Bronchoscope on the Left vs Right Lip Commissure

The goal of this study is to assess the ease of ETT threading over the FOB on the right or left labial commissures in patients aging between 18 and 70 years old with ASA score I-II and undergoing any type of surgery. The main question it aims to answer is whether threading the tube on the right labial commissure during FOB intubation has a better success rate than threading the tube on the left labial commissure. Participants will be randomized via a computerized system into 2 groups (Group 1: Patients intubated with FOB by threading the tube on the left labial commissure and Group 2: Patients intubated with FOB by threading the tube on the right labial commissure). Researchers will compare the success rate of threading the tube on first trial, number of ETT threading trials, time to success, and incidence of intra-procedural complication between the two groups to see if threading the tube on the right labial commissure during FOB intubation has a better success rate than threading the tube on the left labial commissure.

Study Overview

• Status: Completed
• Conditions: Fiberoptic Guided Intubation
• Intervention / Treatment: Procedure: Threading on the left lip commissure; Procedure: Threading on the right lip commmissure

Detailed Description

Fiberoptic bronchoscope (FOB) intubation is the gold standard technique for intubating patients with predicted difficult airway. Different maneuvers have been used to facilitate threading the endotracheal tube (ETT) over the fiberoptic bronchoscope including jaw thrust, stretching the tongue, rotating the ETT 90 degrees anticlockwise or using smaller tubes. To our knowledge threading the ETT with the FOB on the left or right lip commissures has not been investigated previously. Improving the ease of ETT threading on the right or left labial commissures could change our FOB intubation management.

The aim is to assess the ease of ETT threading over the FOB on the right or left labial commissures.

Patients between 18 and 70 years old with ASA score I-II and undergoing any type of surgery in the operating rooms at the American University of Beirut Medical Center will be randomized via a computerized system into 2 groups:

Group 1: Patients intubated with FOB by threading the tube on the left labial commissure Group 2: Patients intubated with FOB by threading the tube on the right labial commissure The primary outcome is the success rate of threading the tube on first trial. Secondary outcomes include number of ETT threading trials, time to success, and incidence of intra-procedural complications.

• Study Type: Interventional
• Enrollment (Actual): 118
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marwan Rizk, MD; Phone Number: 6380 01350000; Email: mr04@aub.edu.lb

Study Locations

• Lebanon
  • Beirut, Lebanon
    • American University of Beirut Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Patient aged 18 to 70 years
• Any surgery requiring general anesthesia
• ASA 1 and 2

Exclusion Criteria:

• Patients aged less than 18 or more than 70 years old.
• ASA 3 and 4 patients.
• Patients who need a rapid sequence induction (including pregnant women) or those who have an increased risk of aspiration.
• Patients who need awake fiberoptic intubation for a difficult airway or any other reason

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Left-sided threading; Patients intubated with fiberoptic bronchoscope by threading the tube on the left labial commissure	Procedure: Threading on the left lip commissure; Threading of the endotracheal tube over the fiberoptic bronchscope from the left lip commissure
Active Comparator: Right-sided threading; Patients intubated with fiberoptic bronchoscope by threading the tube on the right labial commissure	Procedure: Threading on the right lip commmissure; Threading of the endotracheal tube over the fiberoptic bronchoscope from the right lip commissure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
success rate of intubation	the success rate of intubation after threading the tube on the designated commissure on the first trial	up to 30 minutes from anesthesia initiation

Collaborators and Investigators

• Sponsor: American University of Beirut Medical Center
• Investigators: Principal Investigator: Marwan Rizk, MD, American University of Beirut Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): September 12, 2017
• Primary Completion (Actual): March 26, 2020
• Study Completion (Actual): June 26, 2020

Study Registration Dates

• First Submitted: August 14, 2018
• First Submitted That Met QC Criteria: August 18, 2018
• First Posted (Actual): August 21, 2018

Study Record Updates

• Last Update Posted (Estimated): June 16, 2023
• Last Update Submitted That Met QC Criteria: June 15, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Endotracheal intubation; Fiberoptic bronchoscope
• Other Study ID Numbers: ANES.MR.02

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No