NCT05889611

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

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 22, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 22, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

June 5, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 22, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 22, 2024

Completed
Last Updated

June 15, 2023

Status Verified

May 1, 2023

Enrollment Period

1 year

First QC Date

May 22, 2023

Last Update Submit

June 13, 2023

Conditions

Keywords

Spine DiseaseSpine surgeryIntubation Cuff PressureEndotracheal IntubationUpper airways

Outcome Measures

Primary Outcomes (1)

  • Balloon pressure

    Monitoring of balloon pressure following prone position during spine surgery

    Throughout the surgical procedure

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

RECRUITING

MeSH Terms

Conditions

Spinal Diseases

Condition Hierarchy (Ancestors)

Bone DiseasesMusculoskeletal Diseases

Study Officials

  • Nicolas PARTOUCHE, MD

    University Hospitals of Strasbourg

    STUDY DIRECTOR

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

Locations