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Completed

NCT Number: NCT05364281

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

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.

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Key information

Age range

0 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Istanbul University

Istanbul, 34091, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Intracuff pressure measurement

Other

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.

Primary outcomes

  1. Intracuff Pressure

    Time frame: 0th minute (just after the positioning from neutral to surgical position)

    Endotracheal Tube Cuff Pressures in Adenotonsillectomy or Tonsillectomy Surgery Positions in Children

Secondary outcomes

  1. Intracuff Pressure

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Istanbul University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
May 6, 2022
Registry last updated
Jul 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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