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

Tonsillectomy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05364281
• Other study ID #: 2019/155
• Status: Completed
• Start date: August 1, 2019
• Est. completion date: March 1, 2020

Study information

• Verified date: May 2022
• Source: Istanbul University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: March 1, 2020
• Est. primary completion date: March 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 0 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Adenotonsillectomy
• Endotracheal Tube Cuff Pressure
• Position
• Tonsillectomy

Intervention

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.

Locations

Country	Name	City	State
Turkey	Istanbul University	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul University

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

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 M — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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