Lung Injury, AcuteNCT03023670
Lung Protection and Pediatric Cardiac Surgery
A study testing cardiopulmonary bypass in people with Lung Injury, Acute, run by Assiut University at 1 site in Egypt.
Trial summary
The lung is at risk for ischemic insults during total cardiopulmonary bypass because lung perfusion is maintained solely by the bronchial arterial system Read more about this study
- Who is it for?
- Ages 2 to 10 years
- Conditions the study is for
- Lung Injury, Acute
- What is being tested?
- cardiopulmonary bypass
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteEgypt
- Study dates
- Jan 2017to Apr 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 2 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Elective cardiac surgery
- Ventricular septal defect (VSD).
- Atrial septal defect (ASD)
Who cannot join
- Cyanotic heart disease.
- Patients with preoperative chest problems.
- Patients with known renal or hepatic dysfunctions.
- Planned off-pump cardiac surgery.
- Emergency cardiac surgery.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ventilatory Patterns During Cardiopulmonary Bypass In Pediatric Cardiac Surgery
The lung is at risk for ischemic insults during total cardiopulmonary bypass because lung perfusion is maintained solely by the bronchial arterial system
Read the detailed description
The study will be performed in the pediatric cardiothoracic unit, pediatric Assiut University Hospital. After obtaining approval from the local ethics committee and written informed parents consent 60 patients will be included in this study according to the following criteria:
- Conditions
- Lung Injury, Acute
- Being tested
- cardiopulmonary bypass
- Keywords
- Lung, Cardiopulmonary Bypass, Pediatric, Cardiac surgery
- Medical subject headings
- Acute Lung Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cardiopulmonary bypassProcedure or surgery
Also called Control group
Low flow of mixed oxygen / air (1:1L) will be used during the period of cardiopulmonary bypass
cardiopulmonary bypassProcedure or surgery
Also called Low frequency group
Low rate (4\min) with low tidal volume ( 2ml/kg ) will be used during the period of cardiopulmonary bypass.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | This group will include patients with low flow of mixed oxygen / air (1:1L) during the period of cardiopulmonary bypass Receives: Procedure: cardiopulmonary bypass |
| Group B | Active comparator | This group will receive low rate (4\min) with low tidal volume ( 2ml/kg ) during the period of cardiopulmonary bypass. Receives: Procedure: cardiopulmonary bypass |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Computerized tomography chest (CT chest) within 7 days postoperative
Measured: preoperative and within the first 7 days postoperative
Secondary outcomes (4)
Mechanical ventilation
Duration of mechanical ventilation (hours)
Measured: Within the first 7 days postoperative
Intensive care unit stay
Intensive care unit stay
Measured: Within the first 7 days postoperative
Intubation time
Intubation time (hours)
Measured: Within the first 7 days postoperative
Arterial blood gases
Intraoperative and postoperative by appropriate scale
Measured: Within the first 7 days postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2017 (estimated)
- Study startJan 2017
- Primary completionMar 2018
- Study completionApr 2018
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.
- More trials run by Assiut 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, Outcomes assessor
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sayed Kaoud Abd-Elshafy, Assiut University
- Investigators
- Sayed Abd-Elshafy, M.D, Principal investigator, Associate profossor of Anesthesiology and critical care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03023670
- Sponsor's protocol ID
- IRB0000871180
- Status last verified
- Dec 2018
- First submitted
- 11 Jan 2017
- Last updated
- 4 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ventilatory Patterns During Cardiopulmonary Bypass In Pediatric Cardiac Surgery
- ClinicalTrials.gov ID
- NCT03023670
- Acronym / sponsor ID
- IRB0000871180
- Conditions
- Lung Injury, Acute
- Keywords
- Lung, Cardiopulmonary Bypass, Pediatric, Cardiac surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- Mar 2018 (actual)
- Study completion
- Apr 2018 (actual)
- First posted
- 18 Jan 2017 (estimated)
- 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.
The lung is at risk for ischemic insults during total cardiopulmonary bypass because lung perfusion is maintained solely by the bronchial arterial system
Detailed description
The study will be performed in the pediatric cardiothoracic unit, pediatric Assiut University Hospital. After obtaining approval from the local ethics committee and written informed parents consent 60 patients will be included in this study according to the following criteria:
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Procedure: cardiopulmonary bypassThis group will include patients with low flow of mixed oxygen / air (1:1L) during the period of cardiopulmonary bypass |
| Group B | Active comparator | Procedure: cardiopulmonary bypassThis group will receive low rate (4\min) with low tidal volume ( 2ml/kg ) during the period of cardiopulmonary bypass. |
Who may qualify
- Ages
- 2 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Elective cardiac surgery
- Ventricular septal defect (VSD).
- Atrial septal defect (ASD)
Key exclusion criteria (5 listed)
- Cyanotic heart disease.
- Patients with preoperative chest problems.
- Patients with known renal or hepatic dysfunctions.
- Planned off-pump cardiac surgery.
- Emergency cardiac surgery.
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 |
|---|---|---|
| cardiopulmonary bypassAlso: Control groupLow flow of mixed oxygen / air (1:1L) will be used during the period of cardiopulmonary bypass | Procedure or surgery | Group A |
| cardiopulmonary bypassAlso: Low frequency groupLow rate (4\min) with low tidal volume ( 2ml/kg ) will be used during the period of cardiopulmonary bypass. | Procedure or surgery | Group B |
Primary outcome
Change from Baseline Computerized tomography chest (CT chest) within 7 days postoperative
Time frame: preoperative and within the first 7 days postoperative
4 secondary outcomes
Mechanical ventilation
Time frame: Within the first 7 days postoperative
Intensive care unit stay
Time frame: Within the first 7 days postoperative
Intubation time
Time frame: Within the first 7 days postoperative
Arterial blood gases
Time frame: Within the first 7 days postoperative
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 4 Dec 2018.
- Individual participant dataSharing planned: Undecided
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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.
Sayed Abd-Elshafy, M.D principal investigator
Associate profossor of Anesthesiology and critical care
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cardiopulmonary bypass in people with Lung Injury, Acute, run by Assiut 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 3 inclusion and 5 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 4 Dec 2018. 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?
Change from Baseline Computerized tomography chest (CT chest) within 7 days postoperative (time frame: preoperative and within the first 7 days postoperative). 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 4 Dec 2018.