Lung InjuryNCT04962542
Ventilation During Cardiopulmonary Bypass
A study testing ventilation in people with Lung Injury and Postoperative Complications, run by Cairo University at 1 site in Egypt.
Trial summary
Postoperative pulmonary dysfunction (PPD) is a widely reported complication of cardiopulmonary bypass (CPB) although there is improvement in perioperative management, that leads to increased morbidity and mortality in cardiac surgery. Read more about this study
- Who is it for?
- Ages 6 months to 4 years
- Conditions the study is for
- Lung Injury, Postoperative Complications, Pulmonary Collapse
- What is being tested?
- ventilation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Jan 2020to 15 Sep 2021
- 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 6 months to 4 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- American society of anesthesiologist(ASA) II, III.
- Patients with non-cyanotic congenital heart defects undergoing corrective surgeries during CPB [Atrial Septal Defect (ASD), Ventricular Septal Defect (VSD), Common A trio ventricular canal (CAVC)].
Who cannot join
- Any congenital anomalies of the lung as cystic fibrosis, congenial diaphragmatic hernia.
- ASA IV. Patients with congenital cyanotic heart defects. Parents refusal.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
AbulReesh Hospital. faculty of medicine. cairo university
Cairo, 002
About this study
Official title: Comparison Between the Effect of Different Strategies of Ventilation During Cardiopulmonary Bypass on Arterial Oxygenation and Postoperative Pulmonary Dysfunction In Pediatric Patients With Congenital Non-cyanotic Heart Diseases
Postoperative pulmonary dysfunction (PPD) is a widely reported complication of cardiopulmonary bypass (CPB) although there is improvement in perioperative management, that leads to increased morbidity and mortality in cardiac surgery.
Many surgical-related factors can predispose to postoperative pulmonary complications such as the effects of general anesthesia combined with the effects of a median sternotomy, CPB, and the use of topical cooling for myocardial protection.
Read more
Main clinical manifestations of PPD include atelectasis, pleural effusion, and postoperative hypoxemia without clinical symptoms in addition to acute respiratory distress syndrome which is rare to happen but leads to high mortality Different strategies including perioperative management of mechanical ventilation (MV), restrictive transfusion, technical modifications of CPB, and medication administration such as steroids and aprotinin have been developed to lessen impairment of pulmonary function.
A recent meta-analysis identified improvement in oxygenation after weaning from CPB when low tidal volume (LTV) ventilation was maintained or after lung recruitment maneuvers (LRM), as compared to when there was no ventilation (noV). Also, maintaining mechanical ventilation may reduce the inflammation response and tissue damage. So far, available researches regarding whether ventilation during CPB could improve respiratory outcomes is still controversial especially in pediatric patients undergoing corrective surgeries for congenital heart defects.
Read the detailed description
Our study is designed to determine the effect of different strategies of ventilation during CPB on arterial oxygenation and PPD in pediatrics undergoing corrective cardiac surgeries for non-cyanotic congenital anomalies.
Preoperative:
First, a proper and detailed history from the parents will be taken followed by a full and detailed examination of the child then the investigators will check all investigations including complete blood count(CBC), coagulation profile, liver enzymes, kidney function tests, chest X-ray (CXR), echocardiography, and blood grouping.
All patients will be premedicated with atropine 0.01 mg/kg, and midazolam 0.02 mg/kg intramuscular(IM), 30 minutes before induction of anesthesia.
Intraoperative:
the investigators will start with Standard Monitoring as ECG, Pulse oximetry, and non-invasive blood pressure. Then the investigators will proceed to induction using sevoflurane in 50% FiO2 followed by Placement of peripheral IV cannula and IV administration of fentanyl (2 µg/kg) and cisatracurium 0.1 mg/kg then Oral endotracheal intubation and the Capnogram will be connected to monitor End-tidal carbon dioxide(CO2).
The patient will be mechanically ventilated using pressure-controlled mode with a fraction of inspired oxygen(FiO2) 50%, Inspiration to expiration time ratio of 1:2, peak inspiratory pressure (PIP), and respiratory rate will be set according to the age to maintain the range of end-tidal carbon dioxide pressure at 35-45 mmHg in all groups.
Maintenance of anesthesia will be achieved using sevoflurane 2 % in 1:1 oxygen: air, cisatracurium infusion 1-2 mcg/kg/min and Fentanyl 1-5 µg/kg till the time of CPB (1 µg/kg before skin incision,2 µg/kg before sternotomy,2 µg/kg during cannulation) Advanced monitoring where nasopharyngeal temperature probe will be placed, a Central venous catheter to monitor central venous pressure(CVP), and Arterial cannula to monitor invasive blood pressure, then antibiotic will be given after skin test, Standard CPB technique will be used in all patients. Before aortic cannulation, patients will receive IV heparin 300-400 U.kg-1 aiming to produce activated clotting time (ACT) value > 400 sec. A membrane oxygenator (minimax plus; Medtronic's Inc., Anaheim, CA) will be used during CPB. Priming solution in the form of isotonic saline solution supplemented with heparin will be added to fresh whole blood in appropriate amounts to achieve a hematocrit of 20-25% during CPB. Furosemide in a dose of 1 mg/kg will be given to all patients. Anesthesia during CPB will be given by Sevoflurane administrated via a vaporizer inserted into the oxygenator gas supply with a constant gas flow of 3 liters/min. A non-pulsatile roller pump (model10.10.00; Stockett 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, Alpha-stat pH management was used and replacement fluids were added as blood (packed red cells), colloid or crystalloid as indicated.
After application of aortic cross-clamp, cold blood cardioplegia (20 mL/kg for initial dose) with 30 milliequivalent(mEq)/L of potassium, sodium bicarbonate 25 mEq/L, Xylocaine 120 mg/L will be injected into the aortic root, also topical myocardial cooling will be used.
During CPB the patients enrolled in the study will be randomly assigned to three groups using a computer-generated random sequence of numbers.
- Group A (n=20) the lungs will be kept inflated by delivery of oxygen: air 3 liters/min with FiO2 50% pressure-controlled mode, respiratory rate(RR) 20-30/min according to age, PIP will be adjusted to keep Vt 2 mL/kg as possible.
- Group B (n=20) their lungs will be kept inflated by delivery of oxygen: air 3 liters/min with FiO2 50% and continuous positive airway pressure(CPAP) will be maintained via a circle system with airway pressure maintained at 5 cmH2O by positive end expiratory pressure(PEEP) valve. This will be verified by a previously calibrated, in-circuit Bourdon gauge.
- Group C (control group) (n=20) their lungs will be deflated by disconnecting the breathing circuit from the ventilator (passive deflation).
Post CPB, the patient will be mechanically ventilated using pressure-controlled mode with FiO2 50%, Inspiration to expiration time ratio of 1:2, peak inspiratory pressure (PIP), and respiratory rate will be set according to the age to maintain the range of end-tidal carbon dioxide pressure at 35-45 mmHg in all groups.
- Conditions
- Lung Injury, Postoperative Complications, Pulmonary Collapse
- Being tested
- ventilation
- Medical subject headings
- Lung Injury, Postoperative Complications, Pulmonary Atelectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ventilationOther
low volume positive pressure ventilation is better than continuous positive airway pressure and passive deflation on arterial oxygenation and PPD after CPB in pediatrics undergoing cardiac surgeries for non-cyanotic congenital heart defects.
| Study group | Role | What they receive |
|---|---|---|
| ventilated group | Active comparator | the lungs will be kept inflated by delivery of oxygen : air 3 liter/min with FiO2 50% pressure-controlled mode, RR 20/min, PIP will be adjusted to keep Vt 2- 4 mL/kg as possible Receives: Other: ventilation |
| CPAP group | Active comparator | lungs will be kept inflated by delivery of oxygen: air 3 liters/min with FiO2 50% and CPAP will be maintained via a circle system with airway pressure maintained at 5 cm H2O by PEEP valve Receives: Other: ventilation |
| controlled group | No intervention | lungs will be deflated by disconnecting the breathing circuit from the ventilator (passive deflation). |
What is being measured
The primary outcome is the main question the study is designed to answer.
partial pressure of arterial oxygen(PaO2/FIO2) ratio 5 minutes after weaning from CPB.
measuring PaO2/FIO2 ratio in arterial blood gas sample
Measured: 5 minutes after weaning from CPB
Secondary outcomes (4)
PaO2/FIO2 ratio
measuring PaO2/FIO2 ratio in arterial blood gas sample
Measured: after chest closure
PaO2/FIO2 ratio
measuring PaO2/FIO2 ratio in arterial blood gas sample
Measured: 1 hour after arrival to ICU
Chest x-ray
incidence of pleural effusion or lung collapse using portable x-ray machine
Measured: 1 hour after arrival to ICU
oxygenation index
incidence of hypoxemic respiratory failure using an equation(fio2×mean airway pressure)/pao2
Measured: 1 hour after arrival to ICU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2021
- Study start10 Jan 2020
- Primary completion15 Aug 2021
- Study completion15 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung InjuryStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed sabry abdelsalam, Cairo University
- Investigators
- mohamed F yousef, MD, Study director, professor of anesthesia. faculty of medicine. Cairo university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04962542
- Sponsor's protocol ID
- MD-74-2020
- Status last verified
- Apr 2022
- First submitted
- 2 Jul 2021
- Last updated
- 25 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between the Effect of Different Strategies of Ventilation During Cardiopulmonary Bypass on Arterial Oxygenation and Postoperative Pulmonary Dysfunction In Pediatric Patients With Congenital Non-cyanotic Heart Diseases
- ClinicalTrials.gov ID
- NCT04962542
- Acronym / sponsor ID
- MD-74-2020
- Conditions
- Lung Injury, Postoperative Complications, Pulmonary Collapse
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 10 Jan 2020 (actual)
- Primary completion
- 15 Aug 2021 (actual)
- Study completion
- 15 Sep 2021 (actual)
- First posted
- 15 Jul 2021 (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.
Postoperative pulmonary dysfunction (PPD) is a widely reported complication of cardiopulmonary bypass (CPB) although there is improvement in perioperative management, that leads to increased morbidity and mortality in cardiac surgery.
Many surgical-related factors can predispose to postoperative pulmonary complications such as the effects of general anesthesia combined with the effects of a median sternotomy, CPB, and the use of topical cooling for myocardial protection.
Main clinical manifestations of PPD include atelectasis, pleural effusion, and postoperative hypoxemia without clinical symptoms in addition to acute respiratory distress syndrome which is rare to happen but leads to high mortality Different strategies including perioperative management of mechanical ventilation (MV), restrictive transfusion, technical modifications of CPB, and medication administration such as steroids and aprotinin have been developed to lessen impairment of pulmonary function.
A recent meta-analysis identified improvement in oxygenation after weaning from CPB when low tidal volume (LTV) ventilation was maintained or after lung recruitment maneuvers (LRM), as compared to when there was no ventilation (noV). Also, maintaining mechanical ventilation may reduce the inflammation response and tissue damage. So far, available researches regarding whether ventilation during CPB could improve respiratory outcomes is still controversial especially in pediatric patients undergoing corrective surgeries for congenital heart defects.
Detailed description
Our study is designed to determine the effect of different strategies of ventilation during CPB on arterial oxygenation and PPD in pediatrics undergoing corrective cardiac surgeries for non-cyanotic congenital anomalies.
Preoperative:
First, a proper and detailed history from the parents will be taken followed by a full and detailed examination of the child then the investigators will check all investigations including complete blood count(CBC), coagulation profile, liver enzymes, kidney function tests, chest X-ray (CXR), echocardiography, and blood grouping.
All patients will be premedicated with atropine 0.01 mg/kg, and midazolam 0.02 mg/kg intramuscular(IM), 30 minutes before induction of anesthesia.
Intraoperative:
the investigators will start with Standard Monitoring as ECG, Pulse oximetry, and non-invasive blood pressure. Then the investigators will proceed to induction using sevoflurane in 50% FiO2 followed by Placement of peripheral IV cannula and IV administration of fentanyl (2 µg/kg) and cisatracurium 0.1 mg/kg then Oral endotracheal intubation and the Capnogram will be connected to monitor End-tidal carbon dioxide(CO2).
The patient will be mechanically ventilated using pressure-controlled mode with a fraction of inspired oxygen(FiO2) 50%, Inspiration to expiration time ratio of 1:2, peak inspiratory pressure (PIP), and respiratory rate will be set according to the age to maintain the range of end-tidal carbon dioxide pressure at 35-45 mmHg in all groups.
Maintenance of anesthesia will be achieved using sevoflurane 2 % in 1:1 oxygen: air, cisatracurium infusion 1-2 mcg/kg/min and Fentanyl 1-5 µg/kg till the time of CPB (1 µg/kg before skin incision,2 µg/kg before sternotomy,2 µg/kg during cannulation) Advanced monitoring where nasopharyngeal temperature probe will be placed, a Central venous catheter to monitor central venous pressure(CVP), and Arterial cannula to monitor invasive blood pressure, then antibiotic will be given after skin test, Standard CPB technique will be used in all patients. Before aortic cannulation, patients will receive IV heparin 300-400 U.kg-1 aiming to produce activated clotting time (ACT) value > 400 sec. A membrane oxygenator (minimax plus; Medtronic's Inc., Anaheim, CA) will be used during CPB. Priming solution in the form of isotonic saline solution supplemented with heparin will be added to fresh whole blood in appropriate amounts to achieve a hematocrit of 20-25% during CPB. Furosemide in a dose of 1 mg/kg will be given to all patients. Anesthesia during CPB will be given by Sevoflurane administrated via a vaporizer inserted into the oxygenator gas supply with a constant gas flow of 3 liters/min. A non-pulsatile roller pump (model10.10.00; Stockett 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, Alpha-stat pH management was used and replacement fluids were added as blood (packed red cells), colloid or crystalloid as indicated.
After application of aortic cross-clamp, cold blood cardioplegia (20 mL/kg for initial dose) with 30 milliequivalent(mEq)/L of potassium, sodium bicarbonate 25 mEq/L, Xylocaine 120 mg/L will be injected into the aortic root, also topical myocardial cooling will be used.
During CPB the patients enrolled in the study will be randomly assigned to three groups using a computer-generated random sequence of numbers.
- Group A (n=20) the lungs will be kept inflated by delivery of oxygen: air 3 liters/min with FiO2 50% pressure-controlled mode, respiratory rate(RR) 20-30/min according to age, PIP will be adjusted to keep Vt 2 mL/kg as possible.
- Group B (n=20) their lungs will be kept inflated by delivery of oxygen: air 3 liters/min with FiO2 50% and continuous positive airway pressure(CPAP) will be maintained via a circle system with airway pressure maintained at 5 cmH2O by positive end expiratory pressure(PEEP) valve. This will be verified by a previously calibrated, in-circuit Bourdon gauge.
- Group C (control group) (n=20) their lungs will be deflated by disconnecting the breathing circuit from the ventilator (passive deflation).
Post CPB, the patient will be mechanically ventilated using pressure-controlled mode with FiO2 50%, Inspiration to expiration time ratio of 1:2, peak inspiratory pressure (PIP), and respiratory rate will be set according to the age to maintain the range of end-tidal carbon dioxide pressure at 35-45 mmHg in all groups.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ventilated group | Active comparator | Other: ventilationthe lungs will be kept inflated by delivery of oxygen : air 3 liter/min with FiO2 50% pressure-controlled mode, RR 20/min, PIP will be adjusted to keep Vt 2- 4 mL/kg as possible |
| CPAP group | Active comparator | Other: ventilationlungs will be kept inflated by delivery of oxygen: air 3 liters/min with FiO2 50% and CPAP will be maintained via a circle system with airway pressure maintained at 5 cm H2O by PEEP valve |
| controlled group | No intervention | –lungs will be deflated by disconnecting the breathing circuit from the ventilator (passive deflation). |
Who may qualify
- Ages
- 6 months to 4 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- American society of anesthesiologist(ASA) II, III.
- Patients with non-cyanotic congenital heart defects undergoing corrective surgeries during CPB [Atrial Septal Defect (ASD), Ventricular Septal Defect (VSD), Common A trio ventricular canal (CAVC)].
Key exclusion criteria (2 listed)
- Any congenital anomalies of the lung as cystic fibrosis, congenial diaphragmatic hernia.
- ASA IV. Patients with congenital cyanotic heart defects. Parents refusal.
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 |
|---|---|---|
| ventilationlow volume positive pressure ventilation is better than continuous positive airway pressure and passive deflation on arterial oxygenation and PPD after CPB in pediatrics undergoing cardiac surgeries for non-cyanotic congenital heart defects. | Other | CPAP group, ventilated group |
Primary outcome
partial pressure of arterial oxygen(PaO2/FIO2) ratio 5 minutes after weaning from CPB.
Time frame: 5 minutes after weaning from CPB
measuring PaO2/FIO2 ratio in arterial blood gas sample
4 secondary outcomes
PaO2/FIO2 ratio
Time frame: after chest closure
PaO2/FIO2 ratio
Time frame: 1 hour after arrival to ICU
Chest x-ray
Time frame: 1 hour after arrival to ICU
oxygenation index
Time frame: 1 hour after arrival to ICU
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 25 Apr 2022.
- Individual participant dataSharing planned: Undecided
Related trials for Lung Injury
RecruitingObservational study
Exploration of Whole-Brain Radiotherapy Combined With PD-1 Inhibitors on Brain Injury
Small Cell Lung Cancer ( SCLC ), Brain Injury
RecruitingPhase 2
PirfenidoneVsPlacebo as Prophylaxis Against Acute Radiation-induced Lung Injury Following HFRT in Breast Cancer Patients
Acute Lung Injury, Prevention
Enrolling by invitation
Fareon Open Label Device Clinical Trial
Cognitive Dysfunction, Acquired Brain Injury
Not yet recruiting
Strap To Reduce Apnea in Preterm Infants: A Randomized Crossover Trial
Apnea of Prematurity, Intermittent Hypoxemia
Not yet recruitingObservational study
Development and Prospective Validation of the AutoEIT Foundation Model for ARDS
ARDS (Acute Respiratory Distress Syndrome), Respiratory Failure
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.
mohamed F yousef, MD study director
professor of anesthesia. faculty of medicine. Cairo university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ventilation in people with Lung Injury and Postoperative Complications, 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 2 inclusion and 2 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 25 Apr 2022. 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?
partial pressure of arterial oxygen(PaO2/FIO2) ratio 5 minutes after weaning from CPB. (time frame: 5 minutes after weaning from CPB). 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 25 Apr 2022.