Influence of Positive-End-Expiratory-Pressure (PEEP) on Cardiac Output in Mechanically Ventilated Children (IPCOM)

Charité University Medicine Berlin

Status: Completed

Conditions: Hemodynamic Instability; Children, Only; Congenital Heart Disease; Ventilation Therapy; Complications

Treatments: Procedure: PEEP

Study type: Interventional

Funder types: Other

Identifiers

NCT06270485

EA2/224/23

Details and patient eligibility

About

Interventional Trial to determine the Effect of different PEEP levels on Cardiac output and right-ventricular function in mechanically ventilated children < 5 years of age with congenital heart disease.

Full description

Different PEEP-levels will be applied during invasive mechanical ventilation to describe Cardio-pulmonary interactions in children with congenital heart disease (CHD). An additional trial with the same study protocol is planned in a cohort of children with primarily pulmonary disease without CHD after completion of this trial. Esophageal pressure-monitoring, Ultrasound, respiratory mechanics and electrical impedance tomography will be used

Enrollment: 58 patients

Sex: All

Ages: 1 day to 5 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• invasive mechanical ventilation
• congenital heart disease (biventricular anatomy)

Exclusion criteria

• univentricular hearts
• ECMO/VAD

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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58 participants in 1 patient group

ventilated children

Other group

Description:

Application of different PEEP-levels during invasive mechanical ventilation

Treatment:

Procedure: PEEP