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Ventilation During Cardiopulmonary Bypass

Primary Purpose

Lung Injury, Postoperative Complications, Pulmonary Collapse

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
ventilation
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Lung Injury

Eligibility Criteria

6 Months - 4 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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)].

Exclusion Criteria:

  • Any congenital anomalies of the lung as cystic fibrosis, congenial diaphragmatic hernia.

ASA IV. Patients with congenital cyanotic heart defects. Parents refusal.

Sites / Locations

  • AbulReesh Hospital. faculty of medicine. cairo university

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

No Intervention

Arm Label

ventilated group

CPAP group

controlled group

Arm Description

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

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

lungs will be deflated by disconnecting the breathing circuit from the ventilator (passive deflation).

Outcomes

Primary Outcome Measures

partial pressure of arterial oxygen(PaO2/FIO2) ratio 5 minutes after weaning from CPB.
measuring PaO2/FIO2 ratio in arterial blood gas sample

Secondary Outcome Measures

PaO2/FIO2 ratio
measuring PaO2/FIO2 ratio in arterial blood gas sample
PaO2/FIO2 ratio
measuring PaO2/FIO2 ratio in arterial blood gas sample
Chest x-ray
incidence of pleural effusion or lung collapse using portable x-ray machine
oxygenation index
incidence of hypoxemic respiratory failure using an equation(fio2×mean airway pressure)/pao2

Full Information

First Posted
July 2, 2021
Last Updated
April 21, 2022
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT04962542
Brief Title
Ventilation During Cardiopulmonary Bypass
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
January 10, 2020 (Actual)
Primary Completion Date
August 15, 2021 (Actual)
Study Completion Date
September 15, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Injury, Postoperative Complications, Pulmonary Collapse

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ventilated group
Arm Type
Active Comparator
Arm Description
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
Arm Title
CPAP group
Arm Type
Active Comparator
Arm Description
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
Arm Title
controlled group
Arm Type
No Intervention
Arm Description
lungs will be deflated by disconnecting the breathing circuit from the ventilator (passive deflation).
Intervention Type
Other
Intervention Name(s)
ventilation
Intervention Description
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.
Primary Outcome Measure Information:
Title
partial pressure of arterial oxygen(PaO2/FIO2) ratio 5 minutes after weaning from CPB.
Description
measuring PaO2/FIO2 ratio in arterial blood gas sample
Time Frame
5 minutes after weaning from CPB
Secondary Outcome Measure Information:
Title
PaO2/FIO2 ratio
Description
measuring PaO2/FIO2 ratio in arterial blood gas sample
Time Frame
after chest closure
Title
PaO2/FIO2 ratio
Description
measuring PaO2/FIO2 ratio in arterial blood gas sample
Time Frame
1 hour after arrival to ICU
Title
Chest x-ray
Description
incidence of pleural effusion or lung collapse using portable x-ray machine
Time Frame
1 hour after arrival to ICU
Title
oxygenation index
Description
incidence of hypoxemic respiratory failure using an equation(fio2×mean airway pressure)/pao2
Time Frame
1 hour after arrival to ICU

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
4 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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)]. Exclusion Criteria: Any congenital anomalies of the lung as cystic fibrosis, congenial diaphragmatic hernia. ASA IV. Patients with congenital cyanotic heart defects. Parents refusal.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
mohamed F yousef, MD
Organizational Affiliation
professor of anesthesia. faculty of medicine. Cairo university
Official's Role
Study Director
Facility Information:
Facility Name
AbulReesh Hospital. faculty of medicine. cairo university
City
Cairo
ZIP/Postal Code
002
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Ventilation During Cardiopulmonary Bypass

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