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

NCT04262037 | Unknown DMC

• 1 other identifier: N-12/2019 MD
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Congenital Heart Disease; Pulmonary Hypertension

Outcome Measures

Primary Outcomes (3)

• • 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

  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

  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

  10 minutes after initiation of protamine

Secondary Outcomes (2)

• • Lung ultrasound score.

  beginning of surgery

• Change in Lung ultrasound score

  End of suregery

Study Arms (3)

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

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

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

Interventions

lung ultrasound DIAGNOSTIC_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

CPPV; HPPV

Eligibility Criteria

• Age: 4 Months - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University Pediatric Hospitals

Giza, الجيزة, 12555, Egypt

RECRUITING

MeSH Terms

Conditions

Heart Defects, Congenital; Hypertension, Pulmonary

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases

Study Officials

• Salwa Hefnawy, profesor

  Cairo unuversity

  STUDY CHAIR

Central Study Contacts

Mai A Ahmed, MD

CONTACT

01223657694; maimadkour@kasralainy.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Anesthesia

Study Record Dates

• First Submitted: August 13, 2019
• First Posted: February 10, 2020
• Study Start: August 1, 2019
• Primary Completion: July 1, 2020
• Study Completion: November 1, 2020
• Last Updated: February 10, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)