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

NCT03651817 | Completed

• 1 other identifier: KÜ GOKAEK 2018/68
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Changes in respiratory parameters

  from the beginning of the operation to the end of the surgery

• Changes in Invasive blood pressures

  from the beginning of the operation to the end of the surgery

• Changes in heart rate

  from the beginning of the operation to the end of the surgery

• Changes in central venous pressure

  from the beginning of the operation to the end of the surgery

Study Arms (2)

6ml/kg volume

ACTIVE COMPARATOR

Patients ventilation will provided with a tidal volume of 6ml/kg

Device: Mechanical ventilation

8ml/kg volume

ACTIVE COMPARATOR

Patients ventilation will provided with a tidal volume of 8ml/kg

Device: Mechanical ventilation

Interventions

Mechanical ventilation DEVICE

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

6ml/kg volume; 8ml/kg volume

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Undergoing Cardiopulmonary bypass

You may not qualify if:

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

Sponsors & Collaborators

• Kocaeli University: lead

Study Sites (1)

Kocaeli University Hospital

Kocaeli, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Acute Lung Injury; Ventilator-Induced Lung Injury

Interventions

Respiration, Artificial

Condition Hierarchy (Ancestors)

Lung Injury; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Airway Management; Therapeutics; Resuscitation; Emergency Treatment; Respiratory Therapy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 27, 2018
• First Posted: August 29, 2018
• Study Start: October 15, 2018
• Primary Completion: November 20, 2019
• Study Completion: November 21, 2019
• Last Updated: March 5, 2020

Record last verified: 2020-03

Locations

TU (1)