The objective of the study is to investigate the effect of PEEP ventilation with or without a recruitment maneuver on right ventricular afterload in infants undergoing cardiac surgery.
ID
Source
Brief title
Condition
- Congenital cardiac disorders
- Neurological disorders congenital
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Thermodilution Cardiac Index measurement with PiCCO (PiCCO system; Pulsion
Medical Systems, Munich, Germany), right ventricular outflow impedance (TEE),
functional residual capacity (GE Healthcare Engstrom Carestation) and arterial
blood gases will be measured.
Secondary outcome
- Heart rate- Systemic arterial blood pressure- Central venous pressure -
Atrial pressure
Background summary
The goal of mechanical ventilation is to establish an acceptable level of gas
exchange while preventing alveolar overdistention and collapse (1-6). By
applying a lung protective strategy, pro-inflammatory mediators both in the
lung as well as those circulating can be reduced. The reduction of circulating
levels of pro-inflammatory mediators has a positive effect on the development
of multi-organ failure (1,3,4).
Mechanical ventilation in children after cardiac surgery for congenital heart
disease is known to decrease pulmonary blood flow (7) and cardiac output (8). A
progressive fall in cardiac index occurs with increasing PEEP levels, and the
fall becomes significant at PEEP levels higher than 6 cm H2O (9). This might be
explained by overdistention of aerated lung areas in the presence of
atelectatic lung areas, mediated by a significant rise in pulmonary vascular
resistance (9).
In contrast, we are using PEEP levels of 8 - 10 cmH2O in these children without
compromising the hemodynamics. One of the explanations could be that we use
recruitment maneuvers in order to avoid atelectasis and low tidal volumes (6-8
ml/kg) to avoid overdistension. In adult patients, we have shown that this
ventilation strategy does not affect pulmonary vascular resistance or right
ventricular ejection fraction after cardiac surgery (10, 11).
In this study we like to evaluate the effect of PEEP ventilation, with or
without a recruitment maneuver, on right ventricular afterload in small
children undergoing cardiac surgery on cardiopulmonary bypass (CPB), for repair
of congenital heart disease.
Study objective
The objective of the study is to investigate the effect of PEEP ventilation
with or without a recruitment maneuver on right ventricular afterload in
infants undergoing cardiac surgery.
Study design
This study is designed as a prospective, randomised, single centre study. The
total number of patients expected to be enrolled in this trial are 28.
Intervention
All patients will be ventilated For 30 minutes without PEEP, for 30 minutes
with 8 PEEP and with recruitment and PEEP for 30 minutes. After each
ventilation strategy CI will be measured and bloodgas will be sampled from the
arterial line.
Study burden and risks
Not applicable
Van Dyckstraat 110
B-2640 Mortsel
Belgie
Van Dyckstraat 110
B-2640 Mortsel
Belgie
Listed location countries
Age
Inclusion criteria
Children weighing > 5 kg and older than 3 months of age
Cardiac surgery on CPB
Exclusion criteria
Residual intracardiac shunting (evaluated by TEE after CPB)
Hemodynamically instable patients.
Rhythm other than sinus
Tricuspid regurgitation
No informed consent
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL24525.078.08 |