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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03639688
Other study ID # ANES.MR.02
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 12, 2017
Est. completion date June 26, 2020

Study information

Verified date June 2023
Source American University of Beirut Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 118
Est. completion date June 26, 2020
Est. primary completion date March 26, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 70 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Procedure:
Threading on the left lip commissure
Threading of the endotracheal tube over the fiberoptic bronchscope from the left lip commissure
Threading on the right lip commmissure
Threading of the endotracheal tube over the fiberoptic bronchoscope from the right lip commissure

Locations

Country Name City State
Lebanon American University of Beirut Medical Center Beirut

Sponsors (1)

Lead Sponsor Collaborator
American University of Beirut Medical Center

Country where clinical trial is conducted

Lebanon, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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