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

Ventilator-Induced Lung Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03651817
• Other study ID #: KÜ GOKAEK 2018/68
• Status: Completed
• Phase: N/A
• Start date: October 15, 2018
• Est. completion date: November 21, 2019

Study information

• Verified date: March 2020
• Source: Kocaeli University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: November 21, 2019
• Est. primary completion date: November 20, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Undergoing Cardiopulmonary bypass

Exclusion Criteria:

• Severe COPD

• Chronic Anemia

• Active Smoker

• Chronic kidney Disease

Related Conditions & MeSH terms

• Acute Lung Injury
• Lung Injury
• Lung Injury, Acute
• Ventilator Adverse Event
• Ventilator-Induced Lung Injury
• Wounds and Injuries

Intervention

Device:
• Mechanical ventilation
Patients will be ventilated with anesthesia machine according to the group they belong to

Locations

Country	Name	City	State
Turkey	Kocaeli University Hospital	Kocaeli

Sponsors (1)

Lead Sponsor	Collaborator
Kocaeli University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of arterial carbondiokside pressure levels	Investigators will compare the changes in arterial carbondiokside levels in arterial blood gas samples	from the beginning of operation to 6th hour of post-extubation
Secondary	Changes in respiratory parameters	airway pressures will be continuously assessed	from the beginning of the operation to the end of the surgery
Secondary	Changes in Invasive blood pressures	Blood pressure will be continuously recorded and assessed due to time intervals	from the beginning of the operation to the end of the surgery
Secondary	Changes in heart rate	Heart rate will be continuously recorded and assessed due to time intervals	from the beginning of the operation to the end of the surgery
Secondary	Changes in central venous pressure	Continous central venous pressure will ve recorded and assessed due to time intervals	from the beginning of the operation to the end of the surgery