Correct Endotracheal Tube Placement Using Topographical Landmarks

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Anatomic Landmarks; Intubation, Intratracheal
• Intervention / Treatment: Device: Topographical landmark technique of endotracheal tube placement; Device: Intubation guide mark technique of endotracheal tube placement

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 Type: Interventional
• Enrollment (Anticipated): 400
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Amit K Mittal, M.D; Phone Number: 09717611416; Email: amitrgci@gmail.com
• Study Contact Backup: Name: Anil K Patel, DNB; Phone Number: 09781364051; Email: anilpatel2811@gmail.com

Study Locations

• India
  • Delhi
    • Rohini, Delhi, India, 110085
      • Amit
      • Contact: Amit Kr Mittal, MD; Phone Number: 09717611416; Email: amitrgci@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.
Active Comparator: 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.	Device: Intubation guide mark technique of endotracheal tube placement; An endotracheal tube will be placed in this group by using the intubation guide mark.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Rajiv Gandhi Cancer Institute & Research Center, India
• Investigators: Principal Investigator: Amit K Mittal, M.D, Senior Consultant, Department of Anesthesiology, Rajiv Gandhi Cancer Institute and Research centre

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2022
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): January 31, 2023

Study Registration Dates

• First Submitted: June 21, 2022
• First Submitted That Met QC Criteria: June 25, 2022
• First Posted (Actual): June 30, 2022

Study Record Updates

• Last Update Posted (Actual): June 30, 2022
• Last Update Submitted That Met QC Criteria: June 25, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: Endotracheal tube placement; Topographical landmarks of trachea
• Other Study ID Numbers: RES/SCM/35/2019/68

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: If necessary IPD data can be disclosed after patients approval.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes