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NCT03651817

Lung Protection Strategy in Open Heart Surgery: Which Tidal Volume is Better 8ml/kg or 6ml/kg

Completed NA Last updated 5 March 2020
What this trial tests

NA trial testing Mechanical ventilation in Lung Injury, Acute in 32 participants. Completed in 21 November 2019.

Timeline
15 October 2018
Primary endpoint
20 November 2019
21 November 2019

Quick facts

Lead sponsorKocaeli University
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposeprevention
Enrollment32
Start date15 October 2018
Primary completion20 November 2019
Estimated completion21 November 2019
Sites1 location across Turkey (Türkiye)

Drugs / interventions tested

Conditions studied

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:

Other trials of Mechanical ventilation

Trials testing the same drug.

Other recruiting trials for Lung Injury, Acute

Currently open trials in the same condition.

Other Kocaeli University trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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.

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