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NCT05889611 Clinical Trial

Iterative Endotracheal Tube Cuff Pressure Monitoring

Spine Disease Clinical Trial

— SIPBIE  

Official title:
Iterative Endotracheal Tube Cuff Pressure Monitoring

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05889611
Other study ID # 8904
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 22, 2023
Est. completion date March 22, 2024

Study information
Verified date May 2023
Source University Hospital, Strasbourg, France
Contact Nicolas PARTOUCHE, MD
Phone 33 3 68 76 51 09
Email nicolas.partouche@chru-strasbourg.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 100
Est. completion date March 22, 2024
Est. primary completion date March 22, 2024
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion criteria: - 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. Exclusion criteria: - 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)

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
France Service d'Anesthésiologie - Réanimation Chirurgicale - CHU de Strasbourg - France Strasbourg

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Balloon pressure Monitoring of balloon pressure following prone position during spine surgery Throughout the surgical procedure
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