Endotracheal Tube Threading Over the Fiberoptic Bronchoscope

NCT03639688 | Completed DMC

• 1 other identifier: ANES.MR.02
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Fiberoptic Guided Intubation

Keywords

Endotracheal intubation; Fiberoptic bronchoscope

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Left-sided threading

PLACEBO COMPARATOR

Patients intubated with fiberoptic bronchoscope by threading the tube on the left labial commissure

Procedure: Threading on the left lip commissure

Right-sided threading

ACTIVE COMPARATOR

Patients intubated with fiberoptic bronchoscope by threading the tube on the right labial commissure

Procedure: Threading on the right lip commmissure

Interventions

Threading on the left lip commissure PROCEDURE

Threading of the endotracheal tube over the fiberoptic bronchscope from the left lip commissure

Left-sided threading

Threading on the right lip commmissure PROCEDURE

Threading of the endotracheal tube over the fiberoptic bronchoscope from the right lip commissure

Right-sided threading

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• American University of Beirut Medical Center: lead

Study Sites (1)

American University of Beirut Medical Center

Beirut, Lebanon

Location

Study Officials

• Marwan Rizk, MD

  American University of Beirut Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 14, 2018
• First Posted: August 21, 2018
• Study Start: September 12, 2017
• Primary Completion: March 26, 2020
• Study Completion: June 26, 2020
• Last Updated: June 18, 2023

Record last verified: 2023-06

Locations

LE (1)