Prevention of Endotracheal Tube Migration by Cuff Palpation During Robotic Surgical Procedure

June 17, 2020 updated by: Amit Kumar Mittal, Rajiv Gandhi Cancer Institute & Research Center, India

To Evaluate "Three Point Cuff Palpation Technique" for Assessing Optimal Depth of Endotracheal Tube Placement.

After intubation, the endotracheal tube was finally fixed after palpating endotracheal cuff at three sites (just below the cricoid cartilage, at suprasternal level and just below suprasternal notch). Fibre optic bronchoscopy will be done to find distance between tip of endotracheal tube and carina. This distance will be measured repeatedly, after pneumoperitoneum, after trendelenburg position and after making the patient supine at the end of surgery. Change in the distance will be noted.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The endotracheal tube (ETT) will be placed according to the black mark on the tube, post-intubation, the tube will be finally fixed after palpating endotracheal cuff at three sites (below cricoid cartilage, at suprasternal level and just below suprasternal notch). ETT cuff position will be scanned by sonography of airway to confirm the position of the proximal end of the ETT cuff. Fibre optic bronchoscopy will be done to find distance between tip of endotracheal tube and carina. This distance will be measured repeatedly 5 minutes after pneumoperitoneum, 10 minutes after trendelenburg position and 10 minutes after making the patient supine at the end of surgery. Change in the distance will be noted to confirm the migration of ETT.

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • New Delhi
      • Rohini, New Delhi, India, 110085
        • Recruiting
        • Rajiv Gandhi Cancer Institute & Research Center
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients undergoing the robotic urological or gynecological surgery in Trendelenburg position with pneumoperitoneum will be included in the study cohort.

Description

Inclusion Criteria:

  • Robotic uro-oncological surgical procedures of perineum
  • Robotic gynae-oncological surgical procedures of perineum

Exclusion Criteria:

  • Upper airway fibrosis or tracheal stenosis
  • Large neck swelling distorting or deviating the trachea.
  • Head and neck surgeries
  • Laryngeal and tracheal tumour
  • Tracheal surgery
  • Previous tracheostomy
  • previous radiation treatment of neck

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Three point cuff palpation and Blck mark line technique
In "Three point cuff palpation technique" the cuff will be palpated just below the cricothyroid membrane,at the level of suprasternal notch and below the suprasternal notchand the tube is re-positioned in case of any discrepancy between the black mark line technique and three point cuff at three different over the trachea.
Procedure: Three point cuff palpation technique
the ETT is finally positioned according to the Three point cuff technique.
Other Names:
  • Black line mark on the endotracheal tube

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measure the distance between tip of endotracheal tube and Carina by fiber-optic bronchoscopy and measuring scale at various phases of robotic surgical procedure.
Time Frame: Throughout robotic surgical procedure, immediately after intubation, 5 minute after pneumoperitoneum, 10 minutes after trendelenburg position and after dedocking and making patient supine.pneumoperitoneum.
proper endotracheal tube placement is labelled when the distance between the tip of tube and Carina is more than 2.5 cm, after placement the tube by three point cuff palpation technique, its position will be assessed at respective time points.
Throughout robotic surgical procedure, immediately after intubation, 5 minute after pneumoperitoneum, 10 minutes after trendelenburg position and after dedocking and making patient supine.pneumoperitoneum.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
find the effect of cricod cartilage and supra-sternal distance on endotracheal tube tip to Carina distance.
Time Frame: Throughout robotic surgical procedure, immediately after intubation, 5 minute after pneumoperitoneum, 10 minutes after trendelenburg position and after dedocking and making patient supine.
cricoid cartilage to suprasternal distance changes with the position of neck, so it could affect the distance between the endotracheal tube tip and carina as the position of patient changes during various robotic surgical steps.
Throughout robotic surgical procedure, immediately after intubation, 5 minute after pneumoperitoneum, 10 minutes after trendelenburg position and after dedocking and making patient supine.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rajiv Gandhi Cancer Institute & Research Center, India

Investigators

  • Principal Investigator: Amit Kr Mittal, MD, Rajiv Gandhi Cancer Institute And Research Centre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2018

Primary Completion (Anticipated)

January 19, 2021

Study Completion (Anticipated)

March 31, 2021

Study Registration Dates

First Submitted

September 15, 2018

First Submitted That Met QC Criteria

June 17, 2020

First Posted (Actual)

June 22, 2020

Study Record Updates

Last Update Posted (Actual)

June 22, 2020

Last Update Submitted That Met QC Criteria

June 17, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • RES/SCM/30/2018/81

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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