Clinical trial NCT05364281: The Changes of ETT Cuff Pressures After Head and Neck Positions Placed for Adenotonsillectomy and Tonsillectomy in Children
Official title: The Changes of Endotracheal Tube Cuff Pressures While Positioning for Adenotonsillectomy or Tonsillectomy Surgery in Children: A Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Endotracheal Tube Cuff Pressure
Adenotonsillectomy
Tonsillectomy
Position
Keywords: Pediatric Surgery
Endotracheal Tube Cuff Pressure
Adenotonsillectomy
Tonsillectomy
Position
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2022-05-06
Enrollment: 140
Sex: ALL
Minimum age (years): 0
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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 .

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Intracuff Pressure
timeFrame: 0th minute (just after the positioning from neutral to surgical position)
Secondary outcomes:
measure: Intracuff Pressure
timeFrame: From the beginning to the end of the operation before extubation
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University
Study officials:
affiliation: Istanbul University
name: Emine Aysu Salviz, Assoc. Prof.
role: STUDY_DIRECTOR
References:
citation: 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.