NAVA on the PICU and NICU: Feasibility study with children needing mechanical ventilation

NAVA on the PICU and NICU: Feasibility study with children needing mechanical ventilation - feasibility study of NAVA in children and neonates

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON33510

Enrollment

Registered

2009-09-14

Start date

2009-09-24

Completion date

Unknown

Last updated

2024-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

respiratory problems and respiratory failure

Interventions

NAVA First we measure for 3 hours without NAVA with the Edicatheter. After 3 hours we measure with NAVA. The intervention is to activate NAVA and to observe what is happening.

Eligibility

Age

2 Years to 17 Years

Inclusion criteria

Inclusion criteria: PICU: uncomplicated mechanical ventilation: FiO2 1250 grams or gestational age > 29 weeks

Exclusion criteria

Exclusion criteria: Exclusion criteria PICU: - No consent of the parents; - ECMO treatment; - Other ventilator than the Servo-i - Neurological disturbances: brain trauma, status epileptica, disturbance of the mitochondria with neurological problems - Congenital defect of the diaphragm - Esophagal atresia before surgery - Extubation possible within 24 hour.;Exclusioncriteria NICU: - No consent of the parents - Hemodynamically instable - Other ventilator than the Servo-i - Intraventricular hemorrhage, asphyxia, seizure - Sedation too deep, no spontaneous breathing efforts - Extubation possible within 24 hour

Design outcomes

Primary

Measure	Time frame
Primair study parameters Practical feasibility: • Is it easy to bring in the Edi catheter and is it easy to measure the length you need for a specific child? • Can you fix the Edi catheter well because of the risk of aspiration? • Is it possible to bring in an Edi catheter if there is already a enteral feeding tube (to the stomach) in situ? And does the other enteral feeding tube (located in duodenum) influence the EAdi signals? • Do we get a good EAdi signal on the Servo-i?	—

Measure

Time frame

Primair study parameters Practical feasibility: • Is it easy to bring in the Edi catheter and is it easy to measure the length you need for a specific child? • Can you fix the Edi catheter well because of the risk of aspiration? • Is it possible to bring in an Edi catheter if there is already a enteral feeding tube (to the stomach) in situ? And does the other enteral feeding tube (located in duodenum) influence the EAdi signals? • Do we get a good EAdi signal on the Servo-i?

—

Secondary

Measure	Time frame
Secondary study parameters • Do the peak pressures stay below 35 cm H2O and do the difference between peak and PEEP stays between 15 en 20 cm H2O above PEEP? This because of preventing ventilator induced lung injury • Is the EAdi signal decreasing when there is a high pressure support? • What is the effect on the Edi signal after we change from conventional ventilation to NAVA? • What is the procedure for decreasing the NAVA level? Comfort and sedation during NAVA ventilation: • How comfortable is the patient during NAVA ventilation?	—

Measure

Time frame

Secondary study parameters • Do the peak pressures stay below 35 cm H2O and do the difference between peak and PEEP stays between 15 en 20 cm H2O above PEEP? This because of preventing ventilator induced lung injury • Is the EAdi signal decreasing when there is a high pressure support? • What is the effect on the Edi signal after we change from conventional ventilation to NAVA? • What is the procedure for decreasing the NAVA level? Comfort and sedation during NAVA ventilation: • How comfortable is the patient during NAVA ventilation?

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)