Congenital Heart DiseaseNCT04262037
A Comparative Study of Three Modes of Ventilation During CPB in Pediatrics With Pulmonary Hypertension Undergoing Congenital Heart Surgeries
A study testing lung ultrasound in people with Congenital Heart Disease and Pulmonary Hypertension, run by Cairo University at 1 site in Egypt.
Trial summary
Aim of Work: The aim of this randomized, double-blinded, study is to compare between three modes of ventilation during cardiopulmonary bypass in pediatric patients with pulmonary hypertension undergoing corrective cardiac surgeries. Read more about this study
- Who is it for?
- Ages 4 months to 6 years
- Conditions the study is for
- Congenital Heart Disease, Pulmonary Hypertension
- What is being tested?
- lung ultrasound
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2019to Nov 2020
- 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 4 months to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age: 4 months to 6 years.
- ASA I, II, III.
- Patients undergoing atrial septal defect or ventricular septal defect or common atrio-ventricular canal corrective cardiac surgeries on cardiopulmonary bypass
- Patients suffering moderate to severe pulmonary hypertension.
Who cannot join
- Any congenital anomalies of the lung as cystic fibrosis, congenial diaphragmatic hernia.
- ASA IV.
- Mild pulmonary hypertension or normal PAP.
- Patients who will require high doses of inotropes (adrenaline > 0.1 mcg/kg/min or milrinone > 1 mcg/kg/min) will be excluded from the study.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Cairo University Pediatric Hospitals
Giza, الجيزة, 12555
mostafa El berry, 01061892449
About this study
Official title: A Comparative Study of Three Modes of Ventilation During Cardiopulmonary Bypass in Pediatric Patients With Pulmonary Hypertension Undergoing Congenital Heart Disease Surgeries
Aim of Work:
The aim of this randomized, double-blinded, study is to compare between three modes of ventilation during cardiopulmonary bypass in pediatric patients with pulmonary hypertension undergoing corrective cardiac surgeries.
Hypothesis:
The hypothesis of the present study is that high frequency low volume positive pressure ventilation is better than continous positive airway pressure (CPAP)and passive deflation on direct PAP (pulmonary artery pressure ) reading and immediate oxygenation after cardiopulmonary bypass CPB in pediatric patients undergoing cardiac surgeries for congenital heart defects.
Read the detailed description
The patients will be randomized in a double blinded fashion to get enrolled into 3 equal groups: Group HFPPV patients (n = 8) will receive high frequency positive pressure ventilation during cardiopulmonary bypass at tidal volume 2 ml/kg and respiratory rate 80, whereas Group CPPV patients (n = 8 ) will receive continuous positive airway pressure of 10 cmH2O during the bypass, while Control group patients (n = 8 ) will be disconnected from the ventilation (passive deflation) .The study will be conducted in the pediatric cardio-thoracic operation rooms in AbulReesh Hospital in Cairo University.
Advanced Monitoring where Naso-pharyngeal temperature probe will be placed, a Central venous catheter to monitor central venous pressure and an arterial cannula to monitor invasive blood pressure after that, standard cardiopulmonary bypass technique will be used in all patients. Before aortic cannulation, patients will receive IV heparin 400 U.kg-1 aiming to produce activated clotting time ACT value > 400 sec. A membrane oxygenator (minimax plus; Medtronics Inc.) will be used during cardiopulmonary bypass. Priming solution in the form of iso-tonic saline solution supplemented with heparin added to fresh whole blood in appropriate amounts to achieve a haematocrit 20-25% during CPB will be used. Furosemide in a dose of 1 mg/kg/min will be given to all patients. Venting of left heart will be performed with a left atrial vent inserted through a small incision at the inter-atrial septum. Anesthesia during CPB will be given by Sevoflurane administrated via a vaporizer inserted into the oxygenator gas supply with a constant gas flow 3 liter/min. A non-pulsatile roller pump (model10.10.00; Stocket instruments; Munich, Germany) will be used and the pump flow will be adjusted at 2.4 to 2.6 L/min /m2 during the normothermic period targeting mean arterial blood pressure between 40 and 60 mmHg. Moreover, all patients will receive milrinone loading dose of 50mcg/kg/min the maintanence 0.5-1 mcg/kg/min and or adrenaline 0.02-0.1 mcg/kg/min will be utilized to facilitate weaning from CPB.
After sternotomy and direct exposure of the pulmonary artery, the pulmonary artery systolic pressure (PASP) will be monitored by a direct arterial catheter 22 gauge inserted by the surgeon into the pulmonary artery, was calculated and recorded immediately after sternotomy, after aortic clamp removal, and 10 minutes after initiation of protamine infusion).
After application of aortic cross clamp and administration of cold blood cardioplegia solution (Saint Thomas cardioplegic solution) 40 ml/Kg to be followed by doses of 10ml/Kg every 30 minutes.), Group A patients will receive high frequency low volume positive pressure ventilation (HFPPV) during cardiopulmonary bypass at tidal volume Vt 2 ml/kg and respiratory rate RR 80, whereas Group B patients (n =8 ) will receive continous positive airway pressure CPAP of 10 cmH2O, and group C patients will be disconnected from the ventilator (passive deflation) .
Finally, Lung Ultrasound Score will be obtained after induction of anesthesia and at the end of surgery after chest closure, The duration of mechanical ventilation, length of stay in the intensive care unit and immediate post bypass oxygenation as well as the requirement for inotropic and vaso-tropic support during the first 24 hours study period will be recorded for all patients
Lung ultrasound protocol:
Lung ultrasound will be performed after induction of anesthesia and at the end of the operation with a 5-MHz curved array probe (MindrayDC-N6; Mindray; Shenzhen, China). Patients will be investigated in supine position by a well-trained physician recording five seconds videos that will be assessed by two different observers who will be blinded from the patient data. Lung ultrasound will be assessed for the presence of B lines.
- Conditions
- Congenital Heart Disease, Pulmonary Hypertension
- Being tested
- lung ultrasound
- Medical subject headings
- Heart Defects, Congenital, Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lung ultrasoundDiagnostic test
Lung ultrasound will be performed after induction of anesthesia and at the end of the operation with a 5-MHz curved array probe (MindrayDC-N6; Mindray; Shenzhen, China
| Study group | Role | What they receive |
|---|---|---|
| HPPV | Experimental | will receive high frequency positive pressure ventilation during cardiopulmonary bypass at tidal volume 2 ml/kg and respiratory rate 80. Lung ultrasound will be done at the beginning and end of surgery Receives: Diagnostic Test: lung ultrasound |
| CPPV | Experimental | will receive continuous positive airway pressure of 10 cmH2o during the bypass. Lung ultrasound will be done at the beginning and end of surgery Receives: Diagnostic Test: lung ultrasound |
| Control | No intervention | will be disconnected from the ventilation (passive deflation). Lung ultrasound will be done at the beginning and end of surgery.Lung ultrasound will be done at the beginning and end of surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
• Direct pulmonary artery systolic pressure (PASP) measured in mmHg
the pulmonary artery systolic pressure (PASP) will be monitored by a direct arterial catheter 22 gauge inserted by the surgeon into the pulmonary artery, immediately after sternotomy, after aortic clamp removal, and 10 minutes after initiation of protamine infusion
Measured: immediately after sternotomy,
Change in direct pulmonary artery systolic pressure (PASP) measured in mmHg
the pulmonary artery systolic pressure (PASP) will be monitored by a direct arterial catheter 22 gauge inserted by the surgeon into the pulmonary artery, immediately after sternotomy, after aortic clamp removal, and 10 minutes after initiation of protamine infusion
Measured: after aortic clamp removal 10 minutes after initiation of protamin
Change in direct pulmonary artery systolic pressure (PASP) measured in mmHg
he pulmonary artery systolic pressure (PASP) will be monitored by a direct arterial catheter 22 gauge inserted by the surgeon into the pulmonary artery, immediately after sternotomy, after aortic clamp removal, and 10 minutes after initiation of protamine infusion
Measured: 10 minutes after initiation of protamine
Secondary outcomes (2)
• Lung ultrasound score.
The sum of lung comets will produce a score reflecting the extent of LW accumulation. The lung ultrasound score will be obtained by scanning 12-rib interspaces with the probe longitudinally applied perpendicular to the wall. Each hemi-thorax will be divided in six areas: The sum of B-lines found on each scanning site (0: absence; 1: B7 lines: multiple B-lines 7 mm apart; 2: B3 lines: multiple B 3 mm apart; 3: consolidation) yields a score
Measured: beginning of surgery
Change in Lung ultrasound score
The sum of lung comets will produce a score reflecting the extent of LW accumulation. The lung ultrasound score will be obtained by scanning 12-rib interspaces with the probe longitudinally applied perpendicular to the wall. Each hemi-thorax will be divided in six areas: The sum of B-lines found on each scanning site (0: absence; 1: B7 lines: multiple B-lines 7 mm apart; 2: B3 lines: multiple B 3 mm apart; 3: consolidation) yields a score
Measured: End of suregery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2020
- Study start1 Aug 2019
- Primary completionJul 2020 (estimated)
- Study completionNov 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mai Madkour, Cairo University
- Investigators
- Salwa Hefnawy, profesor, Study chair, Cairo unuversity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04262037
- Sponsor's protocol ID
- N-12/2019 MD
- Status last verified
- Feb 2020
- First submitted
- 13 Aug 2019
- Last updated
- 10 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- 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 10 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study of Three Modes of Ventilation During Cardiopulmonary Bypass in Pediatric Patients With Pulmonary Hypertension Undergoing Congenital Heart Disease Surgeries
- ClinicalTrials.gov ID
- NCT04262037
- Acronym / sponsor ID
- N-12/2019 MD
- Conditions
- Congenital Heart Disease, Pulmonary Hypertension
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- Jul 2020 (estimated)
- Study completion
- Nov 2020 (estimated)
- First posted
- 10 Feb 2020 (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.
Aim of Work:
The aim of this randomized, double-blinded, study is to compare between three modes of ventilation during cardiopulmonary bypass in pediatric patients with pulmonary hypertension undergoing corrective cardiac surgeries.
Hypothesis:
The hypothesis of the present study is that high frequency low volume positive pressure ventilation is better than continous positive airway pressure (CPAP)and passive deflation on direct PAP (pulmonary artery pressure ) reading and immediate oxygenation after cardiopulmonary bypass CPB in pediatric patients undergoing cardiac surgeries for congenital heart defects.
Detailed description
The patients will be randomized in a double blinded fashion to get enrolled into 3 equal groups: Group HFPPV patients (n = 8) will receive high frequency positive pressure ventilation during cardiopulmonary bypass at tidal volume 2 ml/kg and respiratory rate 80, whereas Group CPPV patients (n = 8 ) will receive continuous positive airway pressure of 10 cmH2O during the bypass, while Control group patients (n = 8 ) will be disconnected from the ventilation (passive deflation) .The study will be conducted in the pediatric cardio-thoracic operation rooms in AbulReesh Hospital in Cairo University.
Advanced Monitoring where Naso-pharyngeal temperature probe will be placed, a Central venous catheter to monitor central venous pressure and an arterial cannula to monitor invasive blood pressure after that, standard cardiopulmonary bypass technique will be used in all patients. Before aortic cannulation, patients will receive IV heparin 400 U.kg-1 aiming to produce activated clotting time ACT value > 400 sec. A membrane oxygenator (minimax plus; Medtronics Inc.) will be used during cardiopulmonary bypass. Priming solution in the form of iso-tonic saline solution supplemented with heparin added to fresh whole blood in appropriate amounts to achieve a haematocrit 20-25% during CPB will be used. Furosemide in a dose of 1 mg/kg/min will be given to all patients. Venting of left heart will be performed with a left atrial vent inserted through a small incision at the inter-atrial septum. Anesthesia during CPB will be given by Sevoflurane administrated via a vaporizer inserted into the oxygenator gas supply with a constant gas flow 3 liter/min. A non-pulsatile roller pump (model10.10.00; Stocket instruments; Munich, Germany) will be used and the pump flow will be adjusted at 2.4 to 2.6 L/min /m2 during the normothermic period targeting mean arterial blood pressure between 40 and 60 mmHg. Moreover, all patients will receive milrinone loading dose of 50mcg/kg/min the maintanence 0.5-1 mcg/kg/min and or adrenaline 0.02-0.1 mcg/kg/min will be utilized to facilitate weaning from CPB.
After sternotomy and direct exposure of the pulmonary artery, the pulmonary artery systolic pressure (PASP) will be monitored by a direct arterial catheter 22 gauge inserted by the surgeon into the pulmonary artery, was calculated and recorded immediately after sternotomy, after aortic clamp removal, and 10 minutes after initiation of protamine infusion).
After application of aortic cross clamp and administration of cold blood cardioplegia solution (Saint Thomas cardioplegic solution) 40 ml/Kg to be followed by doses of 10ml/Kg every 30 minutes.), Group A patients will receive high frequency low volume positive pressure ventilation (HFPPV) during cardiopulmonary bypass at tidal volume Vt 2 ml/kg and respiratory rate RR 80, whereas Group B patients (n =8 ) will receive continous positive airway pressure CPAP of 10 cmH2O, and group C patients will be disconnected from the ventilator (passive deflation) .
Finally, Lung Ultrasound Score will be obtained after induction of anesthesia and at the end of surgery after chest closure, The duration of mechanical ventilation, length of stay in the intensive care unit and immediate post bypass oxygenation as well as the requirement for inotropic and vaso-tropic support during the first 24 hours study period will be recorded for all patients
Lung ultrasound protocol:
Lung ultrasound will be performed after induction of anesthesia and at the end of the operation with a 5-MHz curved array probe (MindrayDC-N6; Mindray; Shenzhen, China). Patients will be investigated in supine position by a well-trained physician recording five seconds videos that will be assessed by two different observers who will be blinded from the patient data. Lung ultrasound will be assessed for the presence of B lines.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HPPV | Experimental | Diagnostic Test: lung ultrasoundwill receive high frequency positive pressure ventilation during cardiopulmonary bypass at tidal volume 2 ml/kg and respiratory rate 80. Lung ultrasound will be done at the beginning and end of surgery |
| CPPV | Experimental | Diagnostic Test: lung ultrasoundwill receive continuous positive airway pressure of 10 cmH2o during the bypass. Lung ultrasound will be done at the beginning and end of surgery |
| Control | No intervention | –will be disconnected from the ventilation (passive deflation). Lung ultrasound will be done at the beginning and end of surgery.Lung ultrasound will be done at the beginning and end of surgery |
Who may qualify
- Ages
- 4 months to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Age: 4 months to 6 years.
- ASA I, II, III.
- Patients undergoing atrial septal defect or ventricular septal defect or common atrio-ventricular canal corrective cardiac surgeries on cardiopulmonary bypass
- Patients suffering moderate to severe pulmonary hypertension.
Key exclusion criteria (4 listed)
- Any congenital anomalies of the lung as cystic fibrosis, congenial diaphragmatic hernia.
- ASA IV.
- Mild pulmonary hypertension or normal PAP.
- Patients who will require high doses of inotropes (adrenaline > 0.1 mcg/kg/min or milrinone > 1 mcg/kg/min) will be excluded from the study.
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 |
|---|---|---|
| lung ultrasoundLung ultrasound will be performed after induction of anesthesia and at the end of the operation with a 5-MHz curved array probe (MindrayDC-N6; Mindray; Shenzhen, China | Diagnostic test | CPPV, HPPV |
Primary outcome
• Direct pulmonary artery systolic pressure (PASP) measured in mmHg
Time frame: immediately after sternotomy,
the pulmonary artery systolic pressure (PASP) will be monitored by a direct arterial catheter 22 gauge inserted by the surgeon into the pulmonary artery, immediately after sternotomy, after aortic clamp removal, and 10 minutes after initiation of protamine infusion
Change in direct pulmonary artery systolic pressure (PASP) measured in mmHg
Time frame: after aortic clamp removal 10 minutes after initiation of protamin
the pulmonary artery systolic pressure (PASP) will be monitored by a direct arterial catheter 22 gauge inserted by the surgeon into the pulmonary artery, immediately after sternotomy, after aortic clamp removal, and 10 minutes after initiation of protamine infusion
Change in direct pulmonary artery systolic pressure (PASP) measured in mmHg
Time frame: 10 minutes after initiation of protamine
he pulmonary artery systolic pressure (PASP) will be monitored by a direct arterial catheter 22 gauge inserted by the surgeon into the pulmonary artery, immediately after sternotomy, after aortic clamp removal, and 10 minutes after initiation of protamine infusion
2 secondary outcomes
• Lung ultrasound score.
Time frame: beginning of surgery
Change in Lung ultrasound score
Time frame: End of suregery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2020.
- 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.
Salwa Hefnawy, profesor study chair
Cairo unuversity
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing lung ultrasound in people with Congenital Heart Disease and Pulmonary Hypertension, run by Cairo 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 4 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: status not confirmed, as of the sponsor's last update on 10 Feb 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mai A Ahmed, MD (01223657694, maimadkour@kasralainy.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
• Direct pulmonary artery systolic pressure (PASP) measured in mmHg (time frame: immediately after sternotomy,). The study lists 3 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 10 Feb 2020.