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
• Status: Recruiting
• 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
• 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
• 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)

Related Conditions & MeSH terms

• Spinal Diseases
• Spine Disease

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