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DEXAMETHASONE for Non-urgent Thoracic Surgery (SURTHODEX)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05136781
Recruitment Status : Recruiting
First Posted : November 29, 2021
Last Update Posted : November 29, 2021
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire, Amiens

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


Condition or disease
Thoracic Surgery Anesthesiology Corticosteroids Respiratory Complication

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Study Type : Observational
Estimated Enrollment : 1600 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Assessment of DEXAMETHASONE to Prevent Respiratory Complications After Non Urgent Thoracic Surgery
Actual Study Start Date : November 16, 2021
Estimated Primary Completion Date : March 2022
Estimated Study Completion Date : March 2022



Primary Outcome Measures :
  1. incidence of respiratory failure rates between patients receiving or not DEXAMETHASONE [ Time Frame: 7 days following surgery ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who underwent scheduled lung resection surgery
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05136781


Contacts
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Contact: YOHAN GERMAIN, MD 0322037347 yohan.germain@chu-amiens.fr

Locations
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France
Centre Hospitalier Universitaire d'Amiens Recruiting
Amiens, Picardie, France, 80000
Contact: YOHAN GERMAIN, MD    0322037347    yohan.germain@chu-amiens.fr   
Sponsors and Collaborators
Centre Hospitalier Universitaire, Amiens
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Responsible Party: Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov Identifier: NCT05136781    
Other Study ID Numbers: PI2021_843_0202
First Posted: November 29, 2021    Key Record Dates
Last Update Posted: November 29, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Hospitalier Universitaire, Amiens:
Thoracic surgery
Anesthesiology
Corticosteroids
Respiratory Complication
Additional relevant MeSH terms:
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Aneurysm, Dissecting
Aneurysm
Vascular Diseases
Cardiovascular Diseases