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

NCT04440787 | Unknown DMC

• 1 other identifier: RES/SCM/30/2018/81
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Robotic Surgical Procedures

Keywords

Endotracheal intubation; pneumoperitoneum; trendelenburg position; Robotic surgery

Outcome Measures

Primary Outcomes (1)

• Measure the distance between tip of endotracheal tube and Carina by fiber-optic bronchoscopy and measuring scale at various phases of robotic surgical procedure.

  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 Outcomes (1)

• find the effect of cricod cartilage and supra-sternal distance on endotracheal tube tip to Carina distance.

  Throughout robotic surgical procedure, immediately after intubation, 5 minute after pneumoperitoneum, 10 minutes after trendelenburg position and after dedocking and making patient supine.

Study Arms (1)

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

Interventions

Three point cuff palpation technique PROCEDURE

the ETT is finally positioned according to the Three point cuff technique.

Also known as: Black line mark on the endotracheal tube

Three point cuff palpation and Blck mark line technique

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rajiv Gandhi Cancer Institute & Research Center, India: lead

Study Sites (1)

Rajiv Gandhi Cancer Institute & Research center

Rohini, New Delhi, 110085, India

RECRUITING

Related Publications (1)

• Chang CH, Lee HK, Nam SH. The displacement of the tracheal tube during robot-assisted radical prostatectomy. Eur J Anaesthesiol. 2010 May;27(5):478-80. doi: 10.1097/EJA.0b013e328333d587.

  PMID: 19918180 BACKGROUND

MeSH Terms

Conditions

Pneumoperitoneum

Condition Hierarchy (Ancestors)

Peritoneal Diseases; Digestive System Diseases

Study Officials

• Amit Kr Mittal, MD

  Rajiv Gandhi Cancer Institute and Research centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amit Kr Mittal, M.D

CONTACT

01147022323; amitrgci@gmail.com

Mamta Dubey, MD

CONTACT

09891105744; ek_mamta@yahoo.co.in

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant in-charge

Study Record Dates

• First Submitted: September 15, 2018
• First Posted: June 22, 2020
• Study Start: December 1, 2018
• Primary Completion: January 19, 2021
• Study Completion: March 31, 2021
• Last Updated: June 22, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)