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

Robotic Surgical Procedures Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04440787
• Other study ID #: RES/SCM/30/2018/81
• Status: Recruiting
• Start date: December 1, 2018
• Est. completion date: March 31, 2021

Study information

• Verified date: June 2020
• Source: Rajiv Gandhi Cancer Institute & Research Center, India
• Contact: Amit Kr Mittal, M.D
• Phone: 01147022323
• Email: amitrgci[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: March 31, 2021
• Est. primary completion date: January 19, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Robotic Surgical Procedures

Intervention

Procedure:
• Three point cuff palpation technique
the ETT is finally positioned according to the Three point cuff technique.

Locations

Country	Name	City	State
India	Rajiv Gandhi Cancer Institute & Research center	Rohini	New Delhi

Sponsors (1)

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

Country where clinical trial is conducted

India, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	find the effect of cricod cartilage and supra-sternal distance on endotracheal tube tip to Carina distance.	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.