Postoperative Pulmonary DysfunctionNCT03824301
Different Modes of Ventilation During Cardiopulmonary Bypass
A study of Postoperative Pulmonary Dysfunction, run by Ain Shams University at 1 site in Egypt.
Trial summary
66 patients divided into 3 groups with different modes of ventilation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Pulmonary Dysfunction
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteEgypt
- Study dates
- 22 Jan 2017to 20 Nov 2018
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoingvalve surgeries
- Patients undergoing coronary artery bypass grafting surgeries
Who cannot join
- Emergency cases.
- Off-pump surgeries.
- Patients with chronic lung diseases with forced expiratory volume in first second (FEV1) or forced vital capacity (FVC) less than 40% of the predicted value.
- Massive blood transfusion during surgery.
- Complicated surgeries.
- Redo surgeries.
- Patients with decompensated heart failure prior to surgery.
- Patients refusal
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Study Between Different Modes of Ventilation During Cardiopulmonary Bypass and Its Effect on Postoperative Pulmonary Dysfunction
66 patients divided into 3 groups with different modes of ventilation.
Read the detailed description
Sixty-six patients going through open-heart surgeries were included in the study, divided into 3 groups (P: pressure controlled ventilation, V: volume controlled ventilation, C: control) in accordance with the mode of ventilation. Patients studied for chest x-ray, lung ultrasound, arterial oxygen partial pressure to fractional inspired oxygen ratio (PaO2/FiO2), Alveolar-arterial oxygen gradient, static lung compliance and dynamic lung compliance, taken after induction of anesthesia, 1h post cardiopulmonary bypass, 1h after arrival to cardiac surgical unit.
- Conditions
- Postoperative Pulmonary Dysfunction
- Being tested
- Volume controlled ventilation, Pressure controlled ventilation
- Keywords
- cardiopulmonary bypass, pressure-controlled ventilation, volume-controlled ventilation, atelectasis, pleural effusion, lung compliance
- Medical subject headings
- Pulmonary Atelectasis, Pleural Effusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Volume controlled ventilationDevice
Changing modes of ventilation during cardiopulmonary bypass
Pressure controlled ventilationDevice
Applying pressure controlled ventilation during cardiopulmonary bypass Period
| Study group | Role | What they receive |
|---|---|---|
| Volume-controlled ventilation | Active comparator | During cardiopulmonary bypass period the patients were ventilated with volume-controlled ventilation Receives: Device: Volume controlled ventilation |
| Pressure-controlled ventilation | Active comparator | During cardiopulmonary bypass period the patients were ventilated with pressure-controlled ventilation Receives: Device: Pressure controlled ventilation |
| No ventilation | No intervention | During cardiopulmonary bypass period the patients were disconnected from ventilator |
What is being measured
The primary outcome is the main question the study is designed to answer.
chest x-ray
Chest x ray to detect any lung pathology or changes from baseline like pleural effusion, pulmonary edema or pneumonia
Measured: after induction of anesthesia, 1hour post cardiopulmonary bypass and 1hour after arrival to cardiac surgical unit.
lung ultrasonography
Lung ultrasonography to detect any lung changes from baseline or development of consolidation, pulmonary edema or pleural effusion
Measured: after induction of anesthesia, 1hour post cardiopulmonary bypass and 1hour after arrival to cardiac surgical unit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2019
- Study start22 Jan 2017
- Primary completion30 Mar 2018
- Study completion20 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Pulmonary DysfunctionStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- 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, Care provider
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayman Anis Metry, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03824301
- Sponsor's protocol ID
- ASCSH32/17
- Status last verified
- Jan 2019
- First submitted
- 23 Jan 2019
- Last updated
- 31 Jan 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between Different Modes of Ventilation During Cardiopulmonary Bypass and Its Effect on Postoperative Pulmonary Dysfunction
- ClinicalTrials.gov ID
- NCT03824301
- Acronym / sponsor ID
- ASCSH32/17
- Conditions
- Postoperative Pulmonary Dysfunction
- Keywords
- cardiopulmonary bypass, pressure-controlled ventilation, volume-controlled ventilation, atelectasis, pleural effusion, lung compliance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 22 Jan 2017 (actual)
- Primary completion
- 30 Mar 2018 (actual)
- Study completion
- 20 Nov 2018 (actual)
- First posted
- 31 Jan 2019 (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.
66 patients divided into 3 groups with different modes of ventilation.
Detailed description
Sixty-six patients going through open-heart surgeries were included in the study, divided into 3 groups (P: pressure controlled ventilation, V: volume controlled ventilation, C: control) in accordance with the mode of ventilation. Patients studied for chest x-ray, lung ultrasound, arterial oxygen partial pressure to fractional inspired oxygen ratio (PaO2/FiO2), Alveolar-arterial oxygen gradient, static lung compliance and dynamic lung compliance, taken after induction of anesthesia, 1h post cardiopulmonary bypass, 1h after arrival to cardiac surgical unit.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Volume-controlled ventilation | Active comparator | Device: Volume controlled ventilationDuring cardiopulmonary bypass period the patients were ventilated with volume-controlled ventilation |
| Pressure-controlled ventilation | Active comparator | Device: Pressure controlled ventilationDuring cardiopulmonary bypass period the patients were ventilated with pressure-controlled ventilation |
| No ventilation | No intervention | –During cardiopulmonary bypass period the patients were disconnected from ventilator |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients undergoingvalve surgeries
- Patients undergoing coronary artery bypass grafting surgeries
Key exclusion criteria (8 listed)
- Emergency cases.
- Off-pump surgeries.
- Patients with chronic lung diseases with forced expiratory volume in first second (FEV1) or forced vital capacity (FVC) less than 40% of the predicted value.
- Massive blood transfusion during surgery.
- Complicated surgeries.
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 |
|---|---|---|
| Volume controlled ventilationChanging modes of ventilation during cardiopulmonary bypass | Device | Volume-controlled ventilation |
| Pressure controlled ventilationApplying pressure controlled ventilation during cardiopulmonary bypass Period | Device | Pressure-controlled ventilation |
Primary outcome
chest x-ray
Time frame: after induction of anesthesia, 1hour post cardiopulmonary bypass and 1hour after arrival to cardiac surgical unit.
Chest x ray to detect any lung pathology or changes from baseline like pleural effusion, pulmonary edema or pneumonia
lung ultrasonography
Time frame: after induction of anesthesia, 1hour post cardiopulmonary bypass and 1hour after arrival to cardiac surgical unit.
Lung ultrasonography to detect any lung changes from baseline or development of consolidation, pulmonary edema or pleural effusion
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 31 Jan 2019.
- Individual participant dataSharing planned: No
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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 of Postoperative Pulmonary Dysfunction, run by Ain Shams University at 1 site in Egypt.
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 2 inclusion and 8 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 31 Jan 2019. 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 Egypt. 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?
chest x-ray (time frame: after induction of anesthesia, 1hour post cardiopulmonary bypass and 1hour after arrival to cardiac surgical unit.). The study lists 2 primary outcomes in all. 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 31 Jan 2019.