Clinical trial NCT04440787: Prevention of Endotracheal Tube Migration by Cuff Palpation During Robotic Surgical Procedure
Official title: To Evaluate "Three Point Cuff Palpation Technique" for Assessing Optimal Depth of Endotracheal Tube Placement.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Robotic Surgical Procedures
Keywords: Endotracheal intubation
pneumoperitoneum
trendelenburg position
Robotic surgery
Lead sponsor: Rajiv Gandhi Cancer Institute & Research Center, India
Sponsor class: OTHER
First posted: 2020-06-22
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Measure the distance between tip of endotracheal tube and Carina by fiber-optic bronchoscopy and measuring scale at various phases of robotic surgical procedure.
timeFrame: 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:
measure: find the effect of cricod cartilage and supra-sternal distance on endotracheal tube tip to Carina distance.
timeFrame: Throughout robotic surgical procedure, immediately after intubation, 5 minute after pneumoperitoneum, 10 minutes after trendelenburg position and after dedocking and making patient supine.
Other outcomes:
Locations:
city: Rohini
country: India
facility: Rajiv Gandhi Cancer Institute & Research center
state: New Delhi
Study officials:
affiliation: Rajiv Gandhi Cancer Institute and Research centre
name: Amit Kr Mittal, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.