NAVADYN11 : Hemodynamic Impact of a New Ventilatory Support Mode With Diaphragmatic Synchronization

Invasive Ventilatory Support Clinical Trial

Official title:

NAVADYN11 : Hemodynamic Impact of a New Ventilatory Support Mode With Diaphragmatic Synchronization

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01490710
• Other study ID #: 11/6-H
• Status: Terminated
• Phase: N/A
• First received: December 7, 2011
• Last updated: September 2, 2013
• Start date: November 2011

Study information

• Verified date: September 2013
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: France : NA (This research did not enter in the French legislation of biomedical researches, and so did not require an Authorities approval)
• Study type: Interventional

Clinical Trial Summary

Despite spectacular advances since the 90s mechanical ventilation used in intensive care units are amply associated with cardio-respiratory complications: nosocomial pneumonia, lung parenchyma lesions induced by ventilation, hemodynamic instability and ultimately to a significant morbidity and mortality.

NAVA (Neurally Adjusted Assist Ventilation) ventilatory support, provides synchronous support, proportionate to patient's respiratory efforts. More "physiological", this mode would decline its efficacy on patient hemodynamic response. However, to date, no study has focused on hemodynamic impact of NAVA. This is precisely the purpose of NAVADYN11 study, which aims to assess NAVA efficacy on cardiac index in pediatric intensive care unit.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 9
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion criteria:

• Servo-i with NAVA available at patient admission

• Sedation protocol compatible with NAVA functioning

• Parental consent

Non inclusion criteria:

• Digestive pathology incompatible with gastric tube.

• Deep sedation required defined by score ComfortB <11 (cranial traumatism…)

• Brain damage incompatible with spontaneous ventilation

• Duration of intubation too short for investigation

Exclusion criteria:

• Clinical worsening requiring treatment and/or management inconsistent with NAVADYN11 research (CPR, emergency surgery ...). However, the investigator is allowed to reiterate investigation when patient stabilized.

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Invasive Ventilatory Support

Intervention

Other:
• collection of clinical and biological parameters
Investigation focal lies in hemodynamic monitoring during the last 10 minutes (Cardiac Index Assessment and clinico-biological parameters as: ventilatory and respiratory parameters, NIRS, GDS, Omega Score, heart rate, blood pressure, lactate, BNP, perfusion coefficient…)
• assign optimal ventilatory mode
End of study: At the end of the second session, clinician will assign optimal ventilatory mode regarding patient clinical response.

Locations

Country	Name	City	State
France	Nantes University Hospital	Nantes

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assess the impact of NAVA ventilation on hemodynamic parameters	Assess the impact of NAVA ventilation on hemodynamic parameters in children hospitalized in a Paediatric Intensive Care Unit. Endpoint evaluation consists in a non-invasive measurement of cardiac index by esophageal doppler.
Secondary	Omega score	SaO2/SaO2-SvO2
Secondary	Heart rate
Secondary	Blood pressure
Secondary	NIRS
Secondary	Blood gas
Secondary	Lactate
Secondary	BNP
Secondary	Perfusion score
Secondary	Right cardiac work index	if available