NCT05136781

Brief Summary

Thoracic surgery is at high risk of respiratory complications. Despite the improvement of surgical procedures such as video-thoracoscopy, respiratory complications appear in 15 to -20% of procedures. Thoracic surgery induces local pulmonary inflammation which is involved in the occurrence of post-operative respiratory failure. Similarly to the example of the acute respiratory distress syndrome, corticosteroids could reduce lung injury secondary to immunological stress. In addition, recent studies suggest that dexamethasone could lead to a reduction of respiratory complications after major non cardiothoracic surgery. Since dexamethasone is recommended to prevent postoperative nausea and vomiting, around one in two patients receive dexamethasone during anesthetic induction. By retrospective analysis with compensation of bias by propensity score, the investigators aim to assess the effect of dexamethasone to prevent respiratory complications

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
1,600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2021

Typical duration 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

First Submitted

Initial submission to the registry

November 16, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

November 16, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

November 29, 2021

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2024

Completed
Last Updated

April 12, 2023

Status Verified

April 1, 2023

Enrollment Period

2.3 years

First QC Date

November 16, 2021

Last Update Submit

April 11, 2023

Conditions

Thoracic SurgeryAnesthesiologyCorticosteroidsRespiratory Complication

Keywords

Thoracic surgeryAnesthesiologyCorticosteroidsRespiratory Complication

Outcome Measures

Primary Outcomes (1)

  • incidence of respiratory failure rates between patients receiving or not DEXAMETHASONE

    7 days following surgery

Eligibility Criteria

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

Patients who underwent scheduled lung resection surgery

You may qualify if:

  • age : minimum 18 years old
  • Patients who underwent scheduled lung resection surgery

You may not qualify if:

  • absence of patient's consent
  • age under 18 years
  • pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Universitaire d'Amiens

Amiens, Picardie, 80000, France

RECRUITING

Central Study Contacts

YOHAN GERMAIN, MD

CONTACT

0322037347yohan.germain@chu-amiens.fr

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 16, 2021

First Posted

November 29, 2021

Study Start

November 16, 2021

Primary Completion

March 1, 2024

Study Completion

March 1, 2024

Last Updated

April 12, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)