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
1 other identifier
observational
140
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Aug 2019
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2020
CompletedFirst Submitted
Initial submission to the registry
May 4, 2022
CompletedFirst Posted
Study publicly available on registry
May 6, 2022
CompletedJuly 28, 2023
May 1, 2022
7 months
May 4, 2022
July 26, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Intracuff Pressure
From the beginning to the end of the operation before extubation
Study Arms (1)
Study Group
Patients younger than 18 years, who were scheduled for elective adenoidectomy or adenotonsillectomy operation.
Interventions
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.
Eligibility Criteria
Patients younger than 18 years, who were scheduled for elective adenoidectomy or adenotonsillectomy operation, were included in the study .
You may qualify if:
- Younger than 18 years
- American Society of Anesthesiologists (ASA) physical status I- II
- Elective tonsillectomy/ adenotonsillectomy under general anesthesia
You may not qualify if:
- Older than 18 years
- American Society of Anesthesiologists (ASA) physical status \|\>II
- Nasotracheal intubation
- Peroperative tracheotomy requirements
- Respiratory tract infection.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Istanbul University
Istanbul, 34091, Turkey (Türkiye)
Related 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 Mar 9.
PMID: 26956620RESULT
Study Officials
- STUDY DIRECTOR
Emine Aysu Salviz, Assoc. Prof.
Istanbul University
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Attending Anesthesiologist
Study Record Dates
First Submitted
May 4, 2022
First Posted
May 6, 2022
Study Start
August 1, 2019
Primary Completion
March 1, 2020
Study Completion
March 1, 2020
Last Updated
July 28, 2023
Record last verified: 2022-05