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Correct Endotracheal Tube Placement Using Topographical Landmarks

NCT ID: NCT05439109

Last Updated: 2022-06-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-01

Study Completion Date

2023-01-31

Brief Summary

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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

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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

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Intubation, Intratracheal Anatomic Landmarks

Keywords

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Endotracheal tube placement Topographical landmarks of trachea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

All enrolled patients will be intubated by either topographical landmarks of individual tracheal dimensions or by the conventional intubation guide method.
Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors
The primary investigator will provide the information regarding the portion of endotracheal to be kept below the vocal cords to the care provider after measuring the dimensions of the trachea topographically. After tube placement, the tube tip to carina distance will be measured in both topographical and intubation guide mark technique.

Study Groups

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Topographical landmark technique

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.

Group Type EXPERIMENTAL

Topographical landmark technique of endotracheal tube placement

Intervention Type DEVICE

An endotracheal tube will be placed inside the trachea after measuring the individual's estimated tracheal dimensions.

Intubation guide mark technique

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.

Group Type ACTIVE_COMPARATOR

Intubation guide mark technique of endotracheal tube placement

Intervention Type DEVICE

An endotracheal tube will be placed in this group by using the intubation guide mark.

Interventions

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Topographical landmark technique of endotracheal tube placement

An endotracheal tube will be placed inside the trachea after measuring the individual's estimated tracheal dimensions.

Intervention Type DEVICE

Intubation guide mark technique of endotracheal tube placement

An endotracheal tube will be placed in this group by using the intubation guide mark.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* • Age group of 18-75 years

* ASA physical status I-III patients
* Oral intubation for general anesthesia

Exclusion Criteria

* • 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rajiv Gandhi Cancer Institute & Research Center, India

OTHER

Sponsor Role lead

Responsible Party

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Dr. Amit Kumar Mittal

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Amit K Mittal, M.D

Role: PRINCIPAL_INVESTIGATOR

Senior Consultant, Department of Anesthesiology, Rajiv Gandhi Cancer Institute and Research centre

Locations

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Amit

Rohini, National Capital Territory of Delhi, India

Site Status

Countries

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India

Central Contacts

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Amit K Mittal, M.D

Role: CONTACT

Phone: 09717611416

Email: [email protected]

Anil K Patel, DNB

Role: CONTACT

Phone: 09781364051

Email: [email protected]

Facility Contacts

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Amit Kr Mittal, MD

Role: primary

Other Identifiers

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RES/SCM/35/2019/68

Identifier Type: -

Identifier Source: org_study_id