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Perioperative Inhaled Therapy in Carcinological Thoracic Surgery in patients at high risk of postoperative pulmonary complications

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-510564-12-00
Acronym
PI2023_843_0151
Enrollment
266
Registered
2024-10-15
Start date
2025-08-14
Completion date
Unknown
Last updated
2024-10-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

postoperative pulmonary complications

Brief summary

postoperative pulmonary complications (PPC) at D7 post thoracic surgery

Detailed description

Post-operative pulmonary complications at D7 and interaction between group with/without bronchodilator and ARISCAT score, Post-operative pulmonary complications at D7 and interaction between the group with/without bronchodilator and the presence or absence of COPD., Post-operative pulmonary complications at D7 and interaction between the bronchodilator/no bronchodilator group and long-term inhaled anticholinergic therapy, Post-operative pulmonary complications at D28 (assessed as for primary endpoint), Pulmonary function by spirometry on D7 (or day of discharge if earlier) and D28 post-op (measured with the Spirolab® Spirometer validated for bed-side measurements: [including: forced expiratory volume in 1 second (FEV1), forced vital capacity (FVC), Tiffeneau ratio = FEV1/FVCx 100, peak expiratory flow (PEF)] etc.)., Cardiovascular complications (cardiac arrhythmia, acute myocardial infarction according to the 4th universal definition, ischemic or hemorrhagic stroke) at D28 post-op., Postoperative survival status, Quality of life assessed at D7 (or discharge), D28 and 6 months post-operatively using the standardized questionnaire [EuroQol-5D (EQ-5D)] via remote telephone cal, - Potential treatment-related adverse events (investigated daily in hospital): o Flushing o Dry mouth, dysgeusia o Headaches, tremors o Palpitations, atrial fibrillation, extrasystoles, tachycardia (> 100/min over 24h), prolonged QTc (> 450 ms in men and 470 ms in women) o Hypokalemia (< 3.5mmol/l) o Hyperglycemia (> 10 mmol/L)

Interventions

DRUGFORMOTEROL

Sponsors

Centre Hospitalier Universitaire Amiens Picardie
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to 64 Years

Design outcomes

Primary

MeasureTime frame
postoperative pulmonary complications (PPC) at D7 post thoracic surgery

Secondary

MeasureTime frame
Post-operative pulmonary complications at D7 and interaction between group with/without bronchodilator and ARISCAT score, Post-operative pulmonary complications at D7 and interaction between the group with/without bronchodilator and the presence or absence of COPD., Post-operative pulmonary complications at D7 and interaction between the bronchodilator/no bronchodilator group and long-term inhaled anticholinergic therapy, Post-operative pulmonary complications at D28 (assessed as for primary endpoint), Pulmonary function by spirometry on D7 (or day of discharge if earlier) and D28 post-op (measured with the Spirolab® Spirometer validated for bed-side measurements: [including: forced expiratory volume in 1 second (FEV1), forced vital capacity (FVC), Tiffeneau ratio = FEV1/FVCx 100, peak expiratory flow (PEF)] etc.)., Cardiovascular complications (cardiac arrhythmia, acute myocardial infarction according to the 4th universal definition, ischemic or hemorrhagic stroke) at D28 post-op., Po

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026