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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03651817
Enrollment
32
Registered
2018-08-29
Start date
2018-10-15
Completion date
2019-11-21
Last updated
2020-03-05

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

Conditions

Lung Injury, Acute, Ventilator Adverse Event, Ventilator-Induced Lung Injury

Brief summary

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.

Interventions

DEVICEMechanical ventilation

Patients will be ventilated with anesthesia machine according to the group they belong to

Sponsors

Kocaeli University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

* Undergoing Cardiopulmonary bypass

Exclusion criteria

* Severe COPD * Chronic Anemia * Active Smoker * Chronic kidney Disease

Design outcomes

Primary

MeasureTime frameDescription
Change of arterial carbondiokside pressure levelsfrom the beginning of operation to 6th hour of post-extubationInvestigators will compare the changes in arterial carbondiokside levels in arterial blood gas samples

Secondary

MeasureTime frameDescription
Changes in respiratory parametersfrom the beginning of the operation to the end of the surgeryairway pressures will be continuously assessed
Changes in Invasive blood pressuresfrom the beginning of the operation to the end of the surgeryBlood pressure will be continuously recorded and assessed due to time intervals
Changes in heart ratefrom the beginning of the operation to the end of the surgeryHeart rate will be continuously recorded and assessed due to time intervals
Changes in central venous pressurefrom the beginning of the operation to the end of the surgeryContinous central venous pressure will ve recorded and assessed due to time intervals

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026