Iterative Endotracheal Tube Cuff Pressure Monitoring
SIPBIE
1 other identifier
observational
100
1 country
1
Brief Summary
Studies in the medical literature underline the importance of monitoring the pressure of the balloon and the relationship with the incidence cited on the pain and discomfort related to the gesture of the upper airways. There are no formal recommendations in the literature, the French Society of Anesthesia and Resuscitation (SFAR) recommends monitoring the pressure intraoperatively except after intubation. It would be interesting to see and thus make an inventory of the practices, to reiterate the importance of monitoring throughout the gesture and at the change of position to avoid either micro-inhalation linked to under pressure of the balloon or overpressure which causes a potential risk of tracheal injury.
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 Mar 2023
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
March 22, 2023
CompletedFirst Submitted
Initial submission to the registry
May 22, 2023
CompletedFirst Posted
Study publicly available on registry
June 5, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 22, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
March 22, 2024
CompletedJune 15, 2023
May 1, 2023
1 year
May 22, 2023
June 13, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Balloon pressure
Monitoring of balloon pressure following prone position during spine surgery
Throughout the surgical procedure
Eligibility Criteria
Adult patient who has a scheduled spine intervention in the prone position from January 1, 2023 to April 30, 2023.
You may qualify if:
- Elderly patient ≥ 18 years old
- Patient who has a scheduled spine intervention in the prone position from January 1, 2023 to April 30, 2023
- Intubated patient with endotracheal tube under mechanical ventilation
- Sedation and curarization
- ASA 1, 2 and 3
- Duration of surgery \> 1 hour
- Subject not objecting to the reuse of their data for the purposes of this research.
You may not qualify if:
- Subject who expressed their opposition to participating in the study
- ASA 4, difficult intubation and emergency
- Lung pathologies (asthma, COPD, tracheomalacia)
- Severe heart failure
- Septic, cardiogenic or volume shock
- Morbid obesity (BMI \>40)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Service d'Anesthésiologie - Réanimation Chirurgicale - CHU de Strasbourg - France
Strasbourg, 67091, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Nicolas PARTOUCHE, MD
University Hospitals of Strasbourg
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 22, 2023
First Posted
June 5, 2023
Study Start
March 22, 2023
Primary Completion
March 22, 2024
Study Completion
March 22, 2024
Last Updated
June 15, 2023
Record last verified: 2023-05