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NCT03651817
Lung Protection Strategy in Open Heart Surgery: Which Tidal Volume is Better 8ml/kg or 6ml/kg
NA trial testing Mechanical ventilation in Lung Injury, Acute in 32 participants. Completed in 21 November 2019.
20 November 2019
Quick facts
| Lead sponsor | Kocaeli University |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | prevention |
| Enrollment | 32 |
| Start date | 15 October 2018 |
| Primary completion | 20 November 2019 |
| Estimated completion | 21 November 2019 |
| Sites | 1 location across Turkey (Türkiye) |
Drugs / interventions tested
- Mechanical ventilation
Conditions studied
- Lung Injury, Acute — all drugs for Lung Injury, Acute →
- Ventilator-Induced Lung Injury — all drugs for Ventilator-Induced Lung Injury →
- Ventilator Adverse Event — all drugs for Ventilator Adverse Event →
Sponsor
Kocaeli University
Who can join
Adults 18 to 75, any sex, with Lung Injury, Acute or Ventilator-Induced Lung Injury. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Respiratory complications range from 8% to 79% of the frequency after open heart surgery where the patient is on-pump operated by cardiopulmonary machine. There were many changes in physiology due to anesthesia and cardiac surgery which cause volume and barotrauma complications with mechanical ventilation. These complications increase cost by prolonging morbidity and morbidity as well as hospital stay. Intraoperative and postoperative mechanical ventilation strategies can prevent these complications. CPB stimulates the systemic inflammatory response to the secretion of neutrophil, endotoxin and proinflammatory cytokines in the complex, increasing the permeability of the capillaries. Although coronary artery bypass graft surgery (CABG) is associated with a 0.4% to 2.0% acute respiratory distress syndrome (ARDS), mortality is quite high. Lung-protective ventilation strategies commonly used for prevention of ARDS. Ferrando et al. have proposed pulmonary ventilation with a tidal volume (TV) of less than 10 mL / kg as a pulmonary intraoperative protective ventilation strategy. Investigators aimed to compare oxygenation and ventilation parameters with respiratory mechanics in patients who underwent open heart surgery and were ventilated with 6 ml / kg tidal volume and 8 ml / kg TV, which were recommended as lung protective ventilation strategies during anesthesia.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT03651817
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Mechanical ventilation
Trials testing the same drug.
- NCT06087939 — Outcome and Predictors of Mortality of Patients on Prolonged Mechanical Ventilation · not yet recruiting
- NCT06480162 — Mechanical Ventilation on Hippocampus · recruiting
- NCT06316063 — Hemodynamic Effects of Apnoeic Oxygenation With High-flow Nasal Oxygen in Adults Undergoing Laryngeal Surgery · NA · completed
- NCT05853068 — Assessment of PaO2/FiO2 Ratio Pre and POst INTubation · active not recruiting
- NCT06425354 — Use of 'Mechanical Power' as a Predictor of Increased Serum and Pulmonary Proinflammatory Cytokine Concentrations in Pat · recruiting
Other recruiting trials for Lung Injury, Acute
Currently open trials in the same condition.
- NCT04289324 — Open Lung Maneuvers During High Frequency Oscillatory Ventilation in Preterm Infants · NA · recruiting
Other Kocaeli University trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03651817 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Kocaeli University
- Last refreshed: 5 March 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03651817.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing