AzTrials
AzTrials

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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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

Other trials in Egypt

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.

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 groups in NCT04962542
Study groupRoleWhat they receive
ventilated groupActive comparatorthe 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 groupActive comparatorlungs 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 groupNo interventionlungs 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.

  1. 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)
  1. PaO2/FIO2 ratio

    measuring PaO2/FIO2 ratio in arterial blood gas sample

    Measured: after chest closure

  2. PaO2/FIO2 ratio

    measuring PaO2/FIO2 ratio in arterial blood gas sample

    Measured: 1 hour after arrival to ICU

  3. Chest x-ray

    incidence of pleural effusion or lung collapse using portable x-ray machine

    Measured: 1 hour after arrival to ICU

  4. 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.

  1. First posted15 Jul 2021
  2. Study start10 Jan 2020
  3. Primary completion15 Aug 2021
  4. Study completion15 Sep 2021

Resources

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)
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

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.

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