Intubation, IntratrachealNCT05439109
Correct Endotracheal Tube Placement Using Topographical Landmarks
A study testing Topographical landmark technique of endotracheal tube placement and Intubation guide mark technique of endotracheal tube placement in people with Intubation, Intratracheal and Anatomic Landmarks, run by Rajiv Gandhi Cancer Institute & Research Center, India at 1 site in India.
Trial summary
An optimal endotracheal tube depth is ideally required for preventing the complications associated with mal-positioning of the endotracheal tube. The topographical technique of tube placement considering the individual's morphometric dimensions could help to provide optimal tube placement. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Intubation, Intratracheal, Anatomic Landmarks
- What is being tested?
- Topographical landmark technique of endotracheal tube placement and Intubation guide mark technique of endotracheal tube placement
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteIndia
- Study dates
- 1 Jul 2022to 31 Jan 2023
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • Age group of 18-75 years
- ASA physical status I-III patients
- Oral intubation for general anesthesia
Who cannot join
- • Patient with upper airway fibrosis
- Tracheal stenosis or tracheal surgeries
- Previous head and neck surgeries
- Contracture neck or irradiated neck
- Large neck swelling distorting or deviating the trachea
- Laryngeal or tracheal tumor
- Intubations requiring flexo-metallic tubes
- Patient refusal
Trial locations and contacts
1 site in 1 country.
India1 site
Amit
Rohini, National Capital Territory of Delhi, 110085
Amit Kr Mittal, MD, 09717611416, amitrgci@gmail.com
About this study
Official title: To Evaluate the Appropriate Depth of Endotracheal Tube Placement Guided by Topographical Landmarks
An optimal endotracheal tube depth is ideally required for preventing the complications associated with mal-positioning of the endotracheal tube. The topographical technique of tube placement considering the individual's morphometric dimensions could help to provide optimal tube placement. hence, to evaluate the efficacy of the topographical technique in providing the optimal tube placement this study will be conducted.
Read the detailed description
The trachea is a dynamic organ and its length varies by various static and dynamic factors leading to changing the tracheal length and variable endotracheal tube tip to carina (Ti-Ca) distance. Hence, upholding optimal Ti-Ca distance during changing tracheal length is of utmost importance to prevent complications associated with endotracheal tube (ETT) mal-positioning. When the length of ETT, which is to be inserted inside the trachea, is calculated as per an individual's tracheal morphometric dimensions, the appropriate depth of placement could be achieved and tube malpositioning can be prevented. In the topographical landmark technique, an individual tracheal length is estimated by measuring the various distance from mid-thyroid level (corresponds to vocal cords) to manubriosternal joint (corresponds to carina) in the sagittal plane. After estimating the tracheal length, tip to carina distance of 3cm was deducted from the estimated length of the trachea to provide the distance of the endotracheal tube to be kept beyond the vocal cords. Hence, the investigators planned this study to find the "utility and reliability" of the topographical landmark technique compared to the conventional intubation guide mark technique in providing the appropriate depth of endotracheal tube placement.
- Conditions
- Intubation, Intratracheal, Anatomic Landmarks
- Being tested
- Topographical landmark technique of endotracheal tube placement, Intubation guide mark technique of endotracheal tube placement
- Keywords
- Endotracheal tube placement, Topographical landmarks of trachea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topographical landmark technique of endotracheal tube placementDevice
An endotracheal tube will be placed inside the trachea after measuring the individual's estimated tracheal dimensions.
Intubation guide mark technique of endotracheal tube placementDevice
An endotracheal tube will be placed in this group by using the intubation guide mark.
| Study group | Role | What they receive |
|---|---|---|
| Topographical landmark technique | Experimental | Surface anatomic landmarks of an individual's trachea will be measured from the mid-thyroid level (corresponds to vocal cords) to manubriosternal joint (corresponds to carina) in the sagittal plane to estimate tracheal length. Three centimeters will be deducted from the estimated tracheal length to provide the length of the endotracheal tube from the tube tip to be inserted inside the trachea. Receives: Device: Topographical landmark technique of endotracheal tube placement |
| Intubation guide mark technique | Active comparator | Already established and commonly practiced technique, in this technique, the guide mark present above the proximal end of the endotracheal tube cuff will be placed just beyond the vocal cords. Receives: Device: Intubation guide mark technique of endotracheal tube placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endotracheal tube position inside the trachea
Tip to carina distance will be measured by fiber optic bronchoscopy to classify the optimal or suboptimal tube placements in both groups
Measured: through study completion approximately at six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2022
- Study start1 Jul 2022 (estimated)
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intubation, IntratrachealStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- All enrolled patients will be intubated by either topographical landmarks of individual tracheal dimensions or by the conventional intubation guide method.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rajiv Gandhi Cancer Institute & Research Center, India
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Amit Kumar Mittal, Rajiv Gandhi Cancer Institute & Research Center, India
- Investigators
- Amit K Mittal, M.D, Principal investigator, Senior Consultant, Department of Anesthesiology, Rajiv Gandhi Cancer Institute and Research centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05439109
- Sponsor's protocol ID
- RES/SCM/35/2019/68
- Status last verified
- Jun 2022
- First submitted
- 21 Jun 2022
- Last updated
- 30 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: If necessary IPD data can be disclosed after patients approval.
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Evaluate the Appropriate Depth of Endotracheal Tube Placement Guided by Topographical Landmarks
- ClinicalTrials.gov ID
- NCT05439109
- Acronym / sponsor ID
- RES/SCM/35/2019/68
- Conditions
- Intubation, Intratracheal, Anatomic Landmarks
- Keywords
- Endotracheal tube placement, Topographical landmarks of trachea
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Rajiv Gandhi Cancer Institute & Research Center, IndiaUniversity, hospital or other
- Study start
- 1 Jul 2022 (estimated)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Jan 2023 (estimated)
- First posted
- 30 Jun 2022 (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.
An optimal endotracheal tube depth is ideally required for preventing the complications associated with mal-positioning of the endotracheal tube. The topographical technique of tube placement considering the individual's morphometric dimensions could help to provide optimal tube placement. hence, to evaluate the efficacy of the topographical technique in providing the optimal tube placement this study will be conducted.
Detailed description
The trachea is a dynamic organ and its length varies by various static and dynamic factors leading to changing the tracheal length and variable endotracheal tube tip to carina (Ti-Ca) distance. Hence, upholding optimal Ti-Ca distance during changing tracheal length is of utmost importance to prevent complications associated with endotracheal tube (ETT) mal-positioning. When the length of ETT, which is to be inserted inside the trachea, is calculated as per an individual's tracheal morphometric dimensions, the appropriate depth of placement could be achieved and tube malpositioning can be prevented. In the topographical landmark technique, an individual tracheal length is estimated by measuring the various distance from mid-thyroid level (corresponds to vocal cords) to manubriosternal joint (corresponds to carina) in the sagittal plane. After estimating the tracheal length, tip to carina distance of 3cm was deducted from the estimated length of the trachea to provide the distance of the endotracheal tube to be kept beyond the vocal cords. Hence, the investigators planned this study to find the "utility and reliability" of the topographical landmark technique compared to the conventional intubation guide mark technique in providing the appropriate depth of endotracheal tube placement.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- All enrolled patients will be intubated by either topographical landmarks of individual tracheal dimensions or by the conventional intubation guide method.
| Arm | Type | Receives |
|---|---|---|
| Topographical landmark technique | Experimental | Device: Topographical landmark technique of endotracheal tube placementSurface anatomic landmarks of an individual's trachea will be measured from the mid-thyroid level (corresponds to vocal cords) to manubriosternal joint (corresponds to carina) in the sagittal plane to estimate tracheal length. Three centimeters will be deducted from the estimated tracheal length to provide the length of the endotracheal tube from the tube tip to be inserted inside the trachea. |
| Intubation guide mark technique | Active comparator | Device: Intubation guide mark technique of endotracheal tube placementAlready established and commonly practiced technique, in this technique, the guide mark present above the proximal end of the endotracheal tube cuff will be placed just beyond the vocal cords. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- • Age group of 18-75 years
Key exclusion criteria (8 listed)
- • Patient with upper airway fibrosis
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 |
|---|---|---|
| Topographical landmark technique of endotracheal tube placementAn endotracheal tube will be placed inside the trachea after measuring the individual's estimated tracheal dimensions. | Device | Topographical landmark technique |
| Intubation guide mark technique of endotracheal tube placementAn endotracheal tube will be placed in this group by using the intubation guide mark. | Device | Intubation guide mark technique |
Primary outcome
Endotracheal tube position inside the trachea
Time frame: through study completion approximately at six months
Tip to carina distance will be measured by fiber optic bronchoscopy to classify the optimal or suboptimal tube placements in both groups
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2022.
- Individual participant dataSharing planned: Undecided. If necessary IPD data can be disclosed after patients approval.
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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.
Amit K Mittal, M.D principal investigator
Senior Consultant, Department of Anesthesiology, Rajiv Gandhi Cancer Institute and Research centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Topographical landmark technique of endotracheal tube placement and Intubation guide mark technique of endotracheal tube placement in people with Intubation, Intratracheal and Anatomic Landmarks, run by Rajiv Gandhi Cancer Institute & Research Center, India at 1 site in India.
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 8 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: status not confirmed, as of the sponsor's last update on 30 Jun 2022. 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 India. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amit K Mittal, M.D (09717611416, amitrgci@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endotracheal tube position inside the trachea (time frame: through study completion approximately at six months). 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 30 Jun 2022.