Pleural Effusion Clinical Trial
— DrainICUOfficial title:
Thoracic Drains in Intensive Care Units. Comparison of Seldinger and Surgical Methods: A Prospective Randomized Multicenter Study
Verified date | December 2022 |
Source | University Hospital, Clermont-Ferrand |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This prospective randomized multicenter study is intended to investigate tolerance and effectiveness of thoracic drainage conducted by Seldinger technique with small drains, or by a surgical-like technique with large armed drains, in intensive care units patients.
Status | Completed |
Enrollment | 227 |
Est. completion date | June 28, 2023 |
Est. primary completion date | April 4, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Of-age patient (>18years) - Patient admitted in ICU or CCU - Patient requiring a pleural drainage, semi-urgent or planned - Patient with a social security insurance Exclusion Criteria: - Patient under guardianship - Severe or uncompensated bleeding disorders - Thoracic trauma at the acute phase (<6 hours) - Compressive pneumothorax requiring immediate and urgent needle exsufflation - No thoracic drainage (whatever the technique used) performed previously during the same stay in ICU or CCU. |
Country | Name | City | State |
---|---|---|---|
France | CHU | Clermont-Ferrand |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Clermont-Ferrand |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Composite criteria of major and minor complications related to chest drainage | a composite criterion for major complications: organic lesions (spleen, liver, lung, artery, vessel ..., calculated frequency 0.2-1.4%) and post-drainage empyema or infection at the site level insertion rate (calculated frequency 0.2-1.4%) (non-inferiority hypothesis) and
a composite criterion on the other complications (malposition of the drain (calculated frequency of 0.6-6.5%), clogging of the drain (calculated frequency of 8.1-5.2%) or drain drop (calculated frequency 1-21%) (hypothesis of superiority). |
ICU discharge up to 6 months | |
Secondary | Sedation and analgesia doses | Sedation and analgesia doses | Before, during, immediately after the procedure, every day until the removal of the chest tube, immediately after ICU discharge, Day 28 and Day 90 | |
Secondary | Persistent residual pain: numerical pain scale | Evaluated by a numerical pain scale (VAS : 0 = No pain to 10 = Worst possible pain) | ICU discharge up to 6 months | |
Secondary | Evaluation of pain type | Type of pain neuropathic, nociceptive | Before, during, immediately after the procedure, every day until the removal of the chest tube, immediately after ICU discharge, Day 28 and Day 90 | |
Secondary | Evaluation of Pain | Evaluated by a numerical pain scale (if the patient is unable to communicate), or the BPS-NI (behavioral pain scale non-intubated, if the patient is non-intubated and unable to communicate, 3 to 12), or the BPS (behavorial pain scale, if the patient is intubated and unable to communicate, 0 to 12). | Before, during, immediately after the procedure | |
Secondary | Procedural criteria | Number of failures of the procedure | Immediately after the pleural drainage procedure | |
Secondary | Procedural criteria | Number of second operator necessary | Immediately after the pleural drainage procedure | |
Secondary | Procedural criteria | Number of drainage technique changes (cross-over) | Immediately after the pleural drainage procedure | |
Secondary | Ultrasound use | Rate of procedure use by care-providers | Before, during and immediately after the pleural drainage procedure | |
Secondary | Ultrasound use | Volume to be drained according to published methods | Before the pleural drainage procedure | |
Secondary | Ultrasound use | Assessment of pleural fluid type according to published methods | Immediately after the pleural drainage procedure | |
Secondary | Ultrasound use | Control of the position of the drain | Immediately after the pleural drainage procedure | |
Secondary | General characteristics | Type of Indication of drainage | Immediately after the pleural drainage procedure | |
Secondary | General characteristics | Diameter of drain used (millimeter) | Immediately after the pleural drainage procedure | |
Secondary | General characteristics | Diameter and brand of drain used | Immediately after the pleural drainage procedure | |
Secondary | General characteristics | Drainage duration | Immediately after the pleural drainage procedure | |
Secondary | General characteristics | Drain hold time in place | Immediately after the pleural drainage procedure | |
Secondary | General characteristics | Drain insertion site (safety triangle) | Immediately after the pleural drainage procedure | |
Secondary | General characteristics | Use or not of probabilistic antibioprophylaxis | Immediately after the pleural drainage procedure | |
Secondary | General characteristics | Number of differences between the result of the randomization and the doctor's choice in terms of drainage technique | Immediately after the pleural drainage procedure | |
Secondary | Doctor performing drainage | Characteristic's rate (senior or junior, prior experience with drainage technique) | Immediately after the pleural drainage procedure | |
Secondary | General characteristics | Rate of Off-hours drainage | Immediately after the pleural drainage procedure | |
Secondary | Complications' rates | Infections at the insertion site or of pleural cavity during the ICU stay | During the pleural drainage procedure and ICU discharge up to 6 months | |
Secondary | Complications' rates | Post-drainage pneumothorax during the ICU stay | During the pleural drainage procedure and ICU discharge up to 6 months | |
Secondary | Complications' rates | Clogging of drain during the ICU stay | During the pleural drainage procedure and ICU discharge up to 6 months | |
Secondary | Complications' rates | Drain Malposition during the ICU stay | During the pleural drainage procedure and ICU discharge up to 6 months | |
Secondary | Complications' rates | Initiation of post-drainage mechanical ventilation if initially absent during the ICU stay | During the pleural drainage procedure and ICU discharge up to 6 months | |
Secondary | Complications' rates | Per- and post-procedure bleeding during the ICU stay during the ICU stay | During the pleural drainage procedure and ICU discharge up to 6 months | |
Secondary | Complications' rates | Intra- and post-drainage visceral lesions during the ICU stay | During the pleural drainage procedure and ICU discharge up to 6 months | |
Secondary | Complications' rates | Fall of the drain during the stay during the ICU stay | During the pleural drainage procedure and ICU discharge up to 6 months | |
Secondary | Complications' rates | Bad side or drainage site during the ICU stay | During the pleural drainage procedure and ICU discharge up to 6 months | |
Secondary | Complications' rates | Complications associated with drainages made on hold during the ICU stay | During the pleural drainage procedure and ICU discharge up to 6 months | |
Secondary | Patients outcomes | ICU mortality | 6 months | |
Secondary | Patients outcomes | Hospital mortality | 6 months | |
Secondary | Patients outcomes | ICU mortality | Day 28 | |
Secondary | Patients outcomes | Hospital mortality | Day 28 | |
Secondary | Patients outcomes | Days without mechanical ventilation | Day 28 | |
Secondary | Patients outcomes | Days without mechanical ventilation | Day 90 | |
Secondary | Patients outcomes | ICU mortality | Day 90 | |
Secondary | Patients outcomes | Hospital mortality | Day 90 |
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