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A Comparative Study of Three Modes of Ventilation During CPB in Pediatrics With Pulmonary Hypertension Undergoing Congenital Heart Surgeries

Primary Purpose

Congenital Heart Disease, Pulmonary Hypertension

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
lung ultrasound
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Congenital Heart Disease

Eligibility Criteria

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

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Sites / Locations

  • Cairo University Pediatric HospitalsRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

HPPV

CPPV

Control

Arm Description

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

will receive continuous positive airway pressure of 10 cmH2o during the bypass. Lung ultrasound will be done at the beginning and end of surgery

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

Outcomes

Primary Outcome Measures

• 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
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
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

Secondary Outcome Measures

• 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
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

Full Information

First Posted
August 13, 2019
Last Updated
February 6, 2020
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT04262037
Brief Title
A Comparative Study of Three Modes of Ventilation During CPB in Pediatrics With Pulmonary Hypertension Undergoing Congenital Heart Surgeries
Official Title
A Comparative Study of Three Modes of Ventilation During Cardiopulmonary Bypass in Pediatric Patients With Pulmonary Hypertension Undergoing Congenital Heart Disease Surgeries
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2019 (Actual)
Primary Completion Date
July 2020 (Anticipated)
Study Completion Date
November 2020 (Anticipated)

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
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congenital Heart Disease, Pulmonary Hypertension

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
HPPV
Arm Type
Experimental
Arm Description
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
Arm Title
CPPV
Arm Type
Experimental
Arm Description
will receive continuous positive airway pressure of 10 cmH2o during the bypass. Lung ultrasound will be done at the beginning and end of surgery
Arm Title
Control
Arm Type
No Intervention
Arm Description
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
Intervention Type
Diagnostic Test
Intervention Name(s)
lung ultrasound
Intervention Description
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
Primary Outcome Measure Information:
Title
• Direct pulmonary artery systolic pressure (PASP) measured in mmHg
Description
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
Time Frame
immediately after sternotomy,
Title
Change in direct pulmonary artery systolic pressure (PASP) measured in mmHg
Description
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
Time Frame
after aortic clamp removal 10 minutes after initiation of protamin
Title
Change in direct pulmonary artery systolic pressure (PASP) measured in mmHg
Description
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
Time Frame
10 minutes after initiation of protamine
Secondary Outcome Measure Information:
Title
• Lung ultrasound score.
Description
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
Time Frame
beginning of surgery
Title
Change in Lung ultrasound score
Description
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
Time Frame
End of suregery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Months
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mai A Ahmed, MD
Phone
01223657694
Email
maimadkour@kasralainy.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Salwa Hefnawy, profesor
Organizational Affiliation
Cairo unuversity
Official's Role
Study Chair
Facility Information:
Facility Name
Cairo University Pediatric Hospitals
City
Giza
State/Province
الجيزة
ZIP/Postal Code
12555
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
mostafa El berry
Phone
01061892449

12. IPD Sharing Statement

Plan to Share IPD
No

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A Comparative Study of Three Modes of Ventilation During CPB in Pediatrics With Pulmonary Hypertension Undergoing Congenital Heart Surgeries

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