Clinical trial NCT03639688: Endotracheal Tube Threading Over the Fiberoptic Bronchoscope
Official title: The Ease of Threading the Endotracheal Tube Over the Fiberoptic Bronchoscope on the Left vs Right Lip Commissure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fiberoptic Guided Intubation
Keywords: Endotracheal intubation
Fiberoptic bronchoscope
Lead sponsor: American University of Beirut Medical Center
Sponsor class: OTHER
First posted: 2018-08-21
Enrollment: 118
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: success rate of intubation
timeFrame: up to 30 minutes from anesthesia initiation
Secondary outcomes:
Other outcomes:
Locations:
city: Beirut
country: Lebanon
facility: American University of Beirut Medical Center
Study officials:
affiliation: American University of Beirut Medical Center
name: Marwan Rizk, MD
role: PRINCIPAL_INVESTIGATOR
References: