NAVA Helmet in Pediatric Respiratory Failure

January 29, 2014 updated by: Prof. Pier Mannuccio Mannucci, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Patient Ventilator Interaction During Non-invasive Ventilation Delivered With Neurally Adjusted Ventilatory Assist (NAVA-NIV) in Infants Delivered by Helmet: a Pilot Short Term Physiological Study

Neurally Adjusted Ventilatory Assist (NAVA) is a new form of partial support wherein the machine applies positive pressure throughout inspiration in proportion to the electrical activity of the diaphragm (EAdi), Because ventilator functioning and cycling are under control of the patient's respiratory drive and rhythm, NAVA has the potential to enhance patient-ventilator interaction ensuring synchrony and minimizing the risk of over-assistance. Among different interfaces, the pediatric helmet is better tolerated than facial or nasal mask, thus requiring less sedation and allowing more prolonged ventilatory assistance (5-6).To date, no data exist on the use of NAVA in infants during noninvasive ventilation. The aim of this physiological study is to compare patient-ventilator interaction in infants receiving NIV by NAVA and Pressure Support Ventilation (PSV) with helmet.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Neurally Adjusted Ventilatory Assist (NAVA) is a new form of partial support wherein the machine applies positive pressure throughout inspiration in proportion to the electrical activity of the diaphragm (EAdi), as assessed by trans-esophageal electromyography (1). Because ventilator functioning and cycling are under control of the patient's respiratory drive and rhythm, NAVA has the potential to enhance patient-ventilator interaction ensuring synchrony and minimizing the risk of over-assistance. A high incidence of asynchrony events has been demonstrated to have a significant clinical impact by favouring weaning failure and longer duration of mechanical ventilation (2). NAVA has been implemented safely in animals, in healthy volunteers and in critically ill adults and has been shown to improve patient-ventilator synchrony, to limit excessive airway pressure and tidal volume, and to unload the respiratory muscles in tracheally intubated patients (1,3,4). Moreover NAVA was found to be effective in delivering non-invasive ventilation (NIV) even when the interface was excessively leaky (75% leak) with reduced positive end-expiratory pressure (3). With these conditions, NAVA was able to unload the respiratory muscles and preserve gas exchange, while maintaining synchrony to respiratory demand. Data from medical literature from our group demonstrate that the pediatric helmet was better tolerated than facial mask , required less sedation an allowed more prolonged ventilatory assistance due to better tolerance (5-6). To date, no data exist on the use of NAVA in infants during noninvasive ventilation. The aim of this physiological study is to compare patient-ventilator interaction in infants receiving NIV by NAVA and Pressure Support Ventilation (PSV). Equipment. NAVA and conventional PSV is provided by the Servo-I ventilator (Maquet Critical Care, Solna, Sweden). Electrical activity of the diaphragm (EAdi) is obtained using an array of nine miniaturized electrodes (spaced 6 mm apart) mounted on a conventional (5.5F) feeding tube (Maquet Critical Care AB, Solna, Sweden; Neurovent Research Inc, Toronto, Canada), and positioned in the lower esophagus at the level of the diaphragm. Confirmation of appropriate placement is achieved by viewing the online electrical displays from the catheter. The presence of a good quality EAdi trace with p waves displayed by the central electrodes indicates optimal positioning, with the array spanning the diaphragm equally in both caudal and cranial directions. A pediatric helmet is used as interface between the patient and the ventilator. Tidal volume , airway pressure and flow trace are recorded with the Servo I NAVA Tracker acquisition system.

Experimental protocol. Enrolled patients, after a stabilization period with oxygen therapy and standard medical treatment (antibiotics, steroids, Inhaled beta 2 agonists), receive two 60-minutes ventilatory trials delivered by pediatric helmet.

After a baseline trial on PSV conventional , children are allocated to receive 1 trial NAVA NIV and 1 trial PSV conventional. The sequence of the two ventilatory trials are randomized according to sealed opaque envelops.

Ventilatory trials are as follows:

  1. NAVA-NIV
  2. PSV conventional . The first 15 mins of each period are considered as a wash out period and patients are carefully observed for any reactions or problems occurring for the technique. After the first 15 mins period, data recording for the study are started.

NAVA and PSV level are set by the attending physician in order to obtain a Tidal Volume (TV) 6-8 ml/kg, peripheral oxygen saturation (SpO2) > 94%, Respiratory Rate (RR) < +/-2 SD for age. Sedation and analgesia are provided according to standardized PICU protocols, if needed and are not changed during the two study windows for the same patient.

Monitoring .All infants are monitored as follow: SpO2, and EKG continuously; arterial blood pressure every 15 min; arterial blood gases at enrolment and once for each trial. The total amount of drug needed for sedation and/or complications (intolerance to the interface, leaks, gastric distension) are also recorded.

Statistics. No data are available at the moment in medical literature in infants. Based on retrospective data from adult literature, the predicted reduction in the primary end point (AI) with NAVA versus Conventional flow triggered PSV, is around 20%. The power analysis indicated a sample size of 12 patients was needed to demonstrate a 20% reduction in the AI between the two ventilator modes with an alfa and beta risk of 005 and 0.2 respectively. Sample size calculation has been performed with GPower3.1.2 software (Kiel University, Germany)

Study Type

Interventional

Enrollment (Anticipated)

10

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Milan, Italy, 20122
        • Recruiting
        • Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
        • Principal Investigator:
          • Chidini Giovanna, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month to 2 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Infants aging > 1 month and < 2 years
  • ARF (PaO2/FiO2 < 300 mmHg, accessory muscle recruitment, Respiratory Rate more than 2 SD related to age),
  • Intact neuromuscular pathway to the diaphragm

Exclusion Criteria:

  • Hemodynamic instability
  • Reduction in airway protection
  • Coma
  • Contraindication to insert the nasogastric catheter
  • Heart and/or lung transplant
  • Increase in PIC
  • Refusal of the parents or legal guardian

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Noninvasive ventilation
Neurally Adjusted Ventilatory Assist versus Pressure Support flow triggered delivered by helmet
Procedure: Neurally Adjusted Ventilatory Assist

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Asynchrony Index
Time Frame: 60 minutes trial
60 minutes trial

Secondary Outcome Measures

Outcome Measure
Time Frame
Arterial Blood Gases
Time Frame: end of 60 minutes ventilation trial
end of 60 minutes ventilation trial

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Investigators

  • Principal Investigator: Chidini Giovanna, MD, Fondazione IRCCS Ca'Granda Policlinico

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (Anticipated)

June 1, 2014

Study Completion (Anticipated)

December 1, 2014

Study Registration Dates

First Submitted

January 28, 2014

First Submitted That Met QC Criteria

January 29, 2014

First Posted (Estimate)

January 30, 2014

Study Record Updates

Last Update Posted (Estimate)

January 30, 2014

Last Update Submitted That Met QC Criteria

January 29, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GCHIDINI2014

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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