Fiberoptic Guided IntubationNCT03639688
Endotracheal Tube Threading Over the Fiberoptic Bronchoscope
A study testing Threading on the left lip commissure and Threading on the right lip commmissure in people with Fiberoptic Guided Intubation, run by American University of Beirut Medical Center at 1 site in Lebanon.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Fiberoptic Guided Intubation
- What is being tested?
- Threading on the left lip commissure and Threading on the right lip commmissure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 118 participants
- Where
- 1 siteLebanon
- Study dates
- 12 Sep 2017to 26 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patient aged 18 to 70 years
- Any surgery requiring general anesthesia
- ASA 1 and 2
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Fiberoptic Guided Intubation
- Being tested
- Threading on the left lip commissure, Threading on the right lip commmissure
- Keywords
- Endotracheal intubation, Fiberoptic bronchoscope
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Threading on the left lip commissureProcedure or surgery
Threading of the endotracheal tube over the fiberoptic bronchscope from the left lip commissure
Threading on the right lip commmissureProcedure or surgery
Threading of the endotracheal tube over the fiberoptic bronchoscope from the right lip commissure
| Study group | Role | What they receive |
|---|---|---|
| Left-sided threading | Placebo comparator | Patients intubated with fiberoptic bronchoscope by threading the tube on the left labial commissure Receives: 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 Receives: Procedure: Threading on the right lip commmissure |
What is being measured
The primary outcome is the main question the study is designed to answer.
success rate of intubation
the success rate of intubation after threading the tube on the designated commissure on the first trial
Measured: up to 30 minutes from anesthesia initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2018
- Study start12 Sep 2017
- Primary completion26 Mar 2020
- Study completion26 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fiberoptic Guided IntubationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- American University of Beirut Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marwan Rizk, American University of Beirut Medical Center
- Investigators
- Marwan Rizk, MD, Principal investigator, American University of Beirut Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03639688
- Sponsor's protocol ID
- ANES.MR.02
- Status last verified
- Jun 2023
- First submitted
- 14 Aug 2018
- Last updated
- 18 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Ease of Threading the Endotracheal Tube Over the Fiberoptic Bronchoscope on the Left vs Right Lip Commissure
- ClinicalTrials.gov ID
- NCT03639688
- Acronym / sponsor ID
- ANES.MR.02
- Conditions
- Fiberoptic Guided Intubation
- Keywords
- Endotracheal intubation, Fiberoptic bronchoscope
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- American University of Beirut Medical CenterUniversity, hospital or other
- Study start
- 12 Sep 2017 (actual)
- Primary completion
- 26 Mar 2020 (actual)
- Study completion
- 26 Jun 2020 (actual)
- First posted
- 21 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Left-sided threading | Placebo comparator | Procedure: Threading on the left lip commissurePatients intubated with fiberoptic bronchoscope by threading the tube on the left labial commissure |
| Right-sided threading | Active comparator | Procedure: Threading on the right lip commmissurePatients intubated with fiberoptic bronchoscope by threading the tube on the right labial commissure |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient aged 18 to 70 years
- Any surgery requiring general anesthesia
- ASA 1 and 2
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Threading on the left lip commissureThreading of the endotracheal tube over the fiberoptic bronchscope from the left lip commissure | Procedure or surgery | Left-sided threading |
| Threading on the right lip commmissureThreading of the endotracheal tube over the fiberoptic bronchoscope from the right lip commissure | Procedure or surgery | Right-sided threading |
Primary outcome
success rate of intubation
Time frame: up to 30 minutes from anesthesia initiation
the success rate of intubation after threading the tube on the designated commissure on the first trial
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2023.
Related trials for Fiberoptic Guided Intubation
Recruiting
Comparative Study Between Combined Video Laryngoscope and Video Stylet Intubation Versus Combined Video Laryngoscope and Fiberoptic Intubation in a Simulated Difficult Airway
Video Laryngoscope, Airway
RecruitingObservational study
Patient Experience of Transoral Versus Transnasal Awake Tracheal Intubation
Airway Management, Fiberoptic Guided Intubation
Enrolling by invitation
Utilization of Airway Stabilizing Rod to Assist With Laryngeal Mask Airway Guided Fiberoptic Intubation in Adults With Obesity
Adult, Obesity, Morbid
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marwan Rizk, MD principal investigator
American University of Beirut Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Threading on the left lip commissure and Threading on the right lip commmissure in people with Fiberoptic Guided Intubation, run by American University of Beirut Medical Center at 1 site in Lebanon.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Lebanon. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
success rate of intubation (time frame: up to 30 minutes from anesthesia initiation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2023.