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

The Changes of Endotracheal Tube Cuff Pressures While Positioning for Adenotonsillectomy or Tonsillectomy Surgery in Children: A Prospective Observational Study

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.

Study Overview

• Status: Completed
• Conditions: Adenotonsillectomy; Tonsillectomy; Position; Endotracheal Tube Cuff Pressure
• Intervention / Treatment: Other: Intracuff pressure measurement

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 Type: Observational
• Enrollment (Actual): 140

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey, 34091
    • Istanbul University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 second to 18 years (Child, Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Patients younger than 18 years, who were scheduled for elective adenoidectomy or adenotonsillectomy operation, were included in the study .

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Study Group; Patients younger than 18 years, who were scheduled for elective adenoidectomy or adenotonsillectomy operation.	Other: Intracuff pressure measurement; The intracuff pressures were measured and noted after each position (neck extension and placement of mouth gag), at every 5th minute while the operation and before the extubating.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intracuff Pressure	Endotracheal Tube Cuff Pressure at every 5th minute while the operation and before the extubating	From the beginning to the end of the operation before extubation

Collaborators and Investigators

• Sponsor: Istanbul University
• Investigators: Study Director: Emine Aysu Salviz, Assoc. Prof., Istanbul University

Publications and helpful links

General Publications

• Olsen GH, Krishna SG, Jatana KR, Elmaraghy CA, Ruda JM, Tobias JD. Changes in intracuff pressure of cuffed endotracheal tubes while positioning for adenotonsillectomy in children. Paediatr Anaesth. 2016 May;26(5):500-3. doi: 10.1111/pan.12873. Epub 2016 Mar 9.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2019
• Primary Completion (Actual): March 1, 2020
• Study Completion (Actual): March 1, 2020

Study Registration Dates

• First Submitted: May 4, 2022
• First Submitted That Met QC Criteria: May 4, 2022
• First Posted (Actual): May 6, 2022

Study Record Updates

• Last Update Posted (Actual): July 28, 2023
• Last Update Submitted That Met QC Criteria: July 26, 2023
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Tonsillectomy; Adenotonsillectomy; Position; Pediatric Surgery; Endotracheal Tube Cuff Pressure
• Other Study ID Numbers: 2019/155

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No