Correct Endotracheal Tube Placement Using Topographical Landmarks

Intubation, Intratracheal Clinical Trial

Official title:

To Evaluate the Appropriate Depth of Endotracheal Tube Placement Guided by Topographical Landmarks

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05439109
• Other study ID #: RES/SCM/35/2019/68
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2022
• Est. completion date: January 31, 2023

Study information

• Verified date: June 2022
• Source: Rajiv Gandhi Cancer Institute & Research Center, India
• Contact: Amit K Mittal, M.D
• Phone: 09717611416
• Email: amitrgci[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. hence, to evaluate the efficacy of the topographical technique in providing the optimal tube placement this study will be conducted.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 400
• Est. completion date: January 31, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Anatomic Landmarks
• Intubation, Intratracheal

Intervention

Device:
• Topographical landmark technique of endotracheal tube placement
An endotracheal tube will be placed inside the trachea after measuring the individual's estimated tracheal dimensions.
• Intubation guide mark technique of endotracheal tube placement
An endotracheal tube will be placed in this group by using the intubation guide mark.

Locations

Country	Name	City	State
India	Amit	Rohini	Delhi

Sponsors (1)

Lead Sponsor	Collaborator
Rajiv Gandhi Cancer Institute & Research Center, India

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	through study completion approximately at six months