Ventilation During Cardiopulmonary Bypass

NCT04962542 | Completed

• 1 other identifier: MD-74-2020
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Injury; Postoperative Complications; Pulmonary Collapse

Outcome Measures

Primary Outcomes (1)

• partial pressure of arterial oxygen(PaO2/FIO2) ratio 5 minutes after weaning from CPB.

  measuring PaO2/FIO2 ratio in arterial blood gas sample

  5 minutes after weaning from CPB

Secondary Outcomes (4)

• PaO2/FIO2 ratio

  after chest closure

• PaO2/FIO2 ratio

  1 hour after arrival to ICU

• Chest x-ray

  1 hour after arrival to ICU

• oxygenation index

  1 hour after arrival to ICU

Study Arms (3)

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

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

Other: ventilation

controlled group

NO INTERVENTION

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

Interventions

ventilation OTHER

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.

CPAP group; ventilated group

Eligibility Criteria

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

You may qualify if:

• American society of anesthesiologist(ASA) II, III.
• Patients with non-cyanotic congenital heart defects undergoing corrective surgeries during CPB \[Atrial Septal Defect (ASD), Ventricular Septal Defect (VSD), Common A trio ventricular canal (CAVC)\].

You may not qualify if:

• Any congenital anomalies of the lung as cystic fibrosis, congenial diaphragmatic hernia.
• ASA IV. Patients with congenital cyanotic heart defects. Parents refusal.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

AbulReesh Hospital. faculty of medicine. cairo university

Cairo, 002, Egypt

Location

MeSH Terms

Conditions

Lung Injury; Postoperative Complications; Pulmonary Atelectasis

Interventions

Ventilation

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Thoracic Injuries; Wounds and Injuries; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Environment, Controlled; Environment; Environment and Public Health

Study Officials

• mohamed F yousef, MD

  professor of anesthesia. faculty of medicine. Cairo university

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 2, 2021
• First Posted: July 15, 2021
• Study Start: January 10, 2020
• Primary Completion: August 15, 2021
• Study Completion: September 15, 2021
• Last Updated: April 25, 2022

Record last verified: 2022-04

Locations

EG (1)