Lung Injury, AcuteNCT03651817
Lung Protection Strategy in Open Heart Surgery: Which Tidal Volume is Better 8ml/kg or 6ml/kg
A study testing Mechanical ventilation in people with Lung Injury, Acute and Ventilator-Induced Lung Injury, run by Kocaeli University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lung Injury, Acute, Ventilator-Induced Lung Injury, Ventilator Adverse Event
- What is being tested?
- Mechanical ventilation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Oct 2018to 21 Nov 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Undergoing Cardiopulmonary bypass
Who cannot join
- Severe COPD
- Chronic Anemia
- Active Smoker
- Chronic kidney Disease
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- Mechanical ventilation
- Medical subject headings
- Acute Lung Injury, Ventilator-Induced Lung Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mechanical ventilationDevice
Patients will be ventilated with anesthesia machine according to the group they belong to
| Study group | Role | What they receive |
|---|---|---|
| 6ml/kg volume | Active comparator | Patients ventilation will provided with a tidal volume of 6ml/kg Receives: Device: Mechanical ventilation |
| 8ml/kg volume | Active comparator | Patients ventilation will provided with a tidal volume of 8ml/kg Receives: Device: Mechanical ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of arterial carbondiokside pressure levels
Investigators will compare the changes in arterial carbondiokside levels in arterial blood gas samples
Measured: from the beginning of operation to 6th hour of post-extubation
Secondary outcomes (4)
Changes in respiratory parameters
airway pressures will be continuously assessed
Measured: from the beginning of the operation to the end of the surgery
Changes in Invasive blood pressures
Blood pressure will be continuously recorded and assessed due to time intervals
Measured: from the beginning of the operation to the end of the surgery
Changes in heart rate
Heart rate will be continuously recorded and assessed due to time intervals
Measured: from the beginning of the operation to the end of the surgery
Changes in central venous pressure
Continous central venous pressure will ve recorded and assessed due to time intervals
Measured: from the beginning of the operation to the end of the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2018
- Study start15 Oct 2018
- Primary completion20 Nov 2019
- Study completion21 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Injury, AcuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kocaeli University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tülay Çardaközü, Kocaeli University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03651817
- Sponsor's protocol ID
- KÜ GOKAEK 2018/68
- Status last verified
- Mar 2020
- First submitted
- 27 Jul 2018
- Last updated
- 5 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lung Protection Strategy in Open Heart Surgery: Which Tidal Volume is Better 8ml/kg or 6ml/kg
- ClinicalTrials.gov ID
- NCT03651817
- Acronym / sponsor ID
- KÜ GOKAEK 2018/68
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Kocaeli UniversityUniversity, hospital or other
- Study start
- 15 Oct 2018 (actual)
- Primary completion
- 20 Nov 2019 (actual)
- Study completion
- 21 Nov 2019 (actual)
- First posted
- 29 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 6ml/kg volume | Active comparator | Device: Mechanical ventilationPatients ventilation will provided with a tidal volume of 6ml/kg |
| 8ml/kg volume | Active comparator | Device: Mechanical ventilationPatients ventilation will provided with a tidal volume of 8ml/kg |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Undergoing Cardiopulmonary bypass
Key exclusion criteria (4 listed)
- Severe COPD
- Chronic Anemia
- Active Smoker
- Chronic kidney Disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mechanical ventilationPatients will be ventilated with anesthesia machine according to the group they belong to | Device | 6ml/kg volume, 8ml/kg volume |
Primary outcome
Change of arterial carbondiokside pressure levels
Time frame: from the beginning of operation to 6th hour of post-extubation
Investigators will compare the changes in arterial carbondiokside levels in arterial blood gas samples
4 secondary outcomes
Changes in respiratory parameters
Time frame: from the beginning of the operation to the end of the surgery
Changes in Invasive blood pressures
Time frame: from the beginning of the operation to the end of the surgery
Changes in heart rate
Time frame: from the beginning of the operation to the end of the surgery
Changes in central venous pressure
Time frame: from the beginning of the operation to the end of the surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mechanical ventilation in people with Lung Injury, Acute and Ventilator-Induced Lung Injury, run by Kocaeli University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of arterial carbondiokside pressure levels (time frame: from the beginning of operation to 6th hour of post-extubation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2020.