The Changes of ETT Cuff Pressures After Head and Neck Positions Placed for Adenotonsillectomy and Tonsillectomy in Children

Completed

• Conditions: Position; Adenotonsillectomy; Endotracheal Tube Cuff Pressure; Tonsillectomy
• Interventions: Other: Intracuff pressure measurement

• Registration Number: NCT05364281
• Lead Sponsor: Istanbul University

Brief Summary

The main purpose of this study was to assess the effect of each of position (neck extension by under-shoulder pillow and Crowe-Davis retractor use) during adenoidectomy and adenotonsillectomy on the intracuff pressure of ETTs in children.

Detailed Description

The cuff of the endotracheal tube seals the extraluminal airway to facilitate positive-pressure ventilation and reduce subglottic secretion aspiration. As increase or decrease of ETT intracuff pressures can lead to many morbidities. A total of 140 patients younger than 18 years, who were scheduled for elective adenoidectomy or adenotonsillectomy operation, were included in the study . A standardized general anesthetic was given and cuffed endotracheal tubes by the assistance of video laryngoscope were placed in all patients. The pilot balloon of each endotracheal tube was connected to the pressure transducer and standard invasive pressure monitoring was set to measure intracuff pressure values continuously. The first intracuff pressure value was adjusted to 18.4mmHg (25cm H2O) at supine and neutral neck position. The patients then were given appropriate position for the surgery. These positions were neck extension and placement of mouth gag These positions were neutral position, extension by under-shoulder pillow and placement of the mouth gag. The intracuff pressures were measured and noted after each position, at every 5th minute while the operation and before the extubating. If intracuff pressure deviated from the targeted value of 20-30cm H2O at any time, it was set to 25cm H2O again.

Study Timeline

• Study Start: 2019-08-01
• Primary Completion: 2020-03-01
• Study Completion: 2020-03-01
• Status Verified: 2022-05
• Study First Submitted: 2022-05-04
• Study First Submitted QC: 2022-05-04
• Study First Posted: 2022-05-06
• Last Update Submitted: 2023-07-26
• Last Update Posted: 2023-07-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

• Younger than 18 years
• American Society of Anesthesiologists (ASA) physical status I- II
• Elective tonsillectomy/ adenotonsillectomy under general anesthesia

Exclusion Criteria

• Older than 18 years
• American Society of Anesthesiologists (ASA) physical status |>II
• Nasotracheal intubation
• Peroperative tracheotomy requirements
• Respiratory tract infection.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Study Group	Intracuff pressure measurement	Patients younger than 18 years, who were scheduled for elective adenoidectomy or adenotonsillectomy operation.

Primary Outcome Measures

Name	Time	Method
Intracuff Pressure	0th minute (just after the positioning from neutral to surgical position)	Endotracheal Tube Cuff Pressures in Adenotonsillectomy or Tonsillectomy Surgery Positions in Children

Secondary Outcome Measures

Name	Time	Method
Intracuff Pressure	From the beginning to the end of the operation before extubation	Endotracheal Tube Cuff Pressure at every 5th minute while the operation and before the extubating

Trial Locations

Locations (1)

Istanbul University; 🇹🇷 Istanbul, Turkey