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Mechanical Ventilation With Neurally-Adjusted Ventilatory Assist in Patients With ARDS

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by University of Sao Paulo General Hospital
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by (Responsible Party):
University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier:
NCT01519258
First received: December 7, 2011
Last updated: September 13, 2013
Last verified: September 2013
  Purpose

Neurally-Adjusted Ventilatory Assist (NAVA) is a ventilatory mode that uses the electrical activity of the diaphragm to control the mechanical ventilator, offering inspiratory assistance in proportion to respiratory effort to patients who need artificial ventilatory support. It has been shown to improve the interaction between the patient and the mechanical ventilator in several clinical situations, but no previous studies have tried to use it for patients with a severe type of respiratory insufficiency, called Acute Respiratory Distress Syndrome (ARDS). Patients with ARDS benefit form a mechanical ventilatory strategy that includes low inspiratory volumes (tidal volumes) and limited airway pressures, but the application of such strategy frequently requires high levels of sedation. The investigators' hypothesis is that NAVA can be used for patients with ARDS, and that it will not be associated with excessive tidal volumes or elevated airway pressures.


Condition Intervention
Acute Respiratory Distress Syndrome
Device: NAVA ventilation
Other: Pressure Support ventilation

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Performance of NAVA as Lung Protective Mechanical Ventilation in Patients With Acute Respiratory Distress Syndrome

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo General Hospital:

Primary Outcome Measures:
  • Tidal volume [ Time Frame: 15 min ] [ Designated as safety issue: No ]
    Tidal volume will be recorded breath by breath for 15 minutes


Secondary Outcome Measures:
  • respiratory rate [ Time Frame: 15 min ] [ Designated as safety issue: No ]
    Respiratory rate will be recorded breath by breath for 15 minutes

  • Prolonged NAVA ventilation [ Time Frame: 3 hours ] [ Designated as safety issue: No ]
    patients will be kept on NAVA for three hours after the first part of the protocol, to evaluate the feasibility of ventilating these patients with NAVA for prolonged periods


Estimated Enrollment: 20
Study Start Date: October 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: PSV
Patients will be ventilated with the a conventional mode of ventilation called Pressure Support for 15 minutes. Mechanical ventilator settings will be set by the ICU team without interference from the investigators, in accordance to current standard of care recommendations.
Device: NAVA ventilation
Mechanical ventilation with the mode NAVA (neurally-adjusted ventilatory support), delivered by the Servoi Mechanical Ventilator (Maquet, Sweden) after the placement of an esophageal catheter. Nava will be titrated before the initiation of data collection to offer the same level of ventilatory assistance as the conventional mode used by the ICU team previous to enrollment in the study.
Other: Pressure Support ventilation
Patients will receive usual care during the period of ventilation on the Pressure Support. The same ventilator, the Servoi (maquet, Sweden) will be used.
Experimental: NAVA
Patients will be ventilated with NAVA for 15 minutes. Back up settings in pressure support mode will be set in case the esophageal catheter is misplaced, and back up settings in pressure control ventilation will be set in case no inspiratory efforts are detected for longer than 15 seconds
Device: NAVA ventilation
Mechanical ventilation with the mode NAVA (neurally-adjusted ventilatory support), delivered by the Servoi Mechanical Ventilator (Maquet, Sweden) after the placement of an esophageal catheter. Nava will be titrated before the initiation of data collection to offer the same level of ventilatory assistance as the conventional mode used by the ICU team previous to enrollment in the study.
Other: Pressure Support ventilation
Patients will receive usual care during the period of ventilation on the Pressure Support. The same ventilator, the Servoi (maquet, Sweden) will be used.

Detailed Description:

Neurally Adjusted ventilatory-Assist(NAVA) is an assisted ventilatory mode that captures the electrical activity of the diaphragm and uses it to initiate and terminate the inspiratory phase, offering inspiratory assistance in proportion to patient effort, cycle by cycle. Studies in animals and humans have shown that NAVA reduces the work of breathing and improves patient-ventilator interaction in comparison with traditional modes. Because it is an assisted mode, its use requires less sedation.

The use of NAVA could contribute to the reduction of complications of prolonged mechanical ventilation in patients with Acute Respiratory Distress Syndrome (ARDS) submitted to protective ventilation with low tidal volumes and limited plateau pressure. However, there are no studies with NAVA in the acute phase of ARDS, in which assisted-controlled modes are generally used, allowing for adjustment of tidal volume and/or plateau pressure.

With this project, the investigators intend to evaluate the behavior of NAVA mode in the acute phase of mechanical ventilation in ARDS patients, to assess whether this mode can be used to deliver an assisted lung protective ventilation strategy.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Mechanical ventilation for more than 24 hours;
  • Diagnosis of ARDS
  • Clinical indication of lung protective mechanical ventilation by the ICU team;
  • Presence of active inspiratory efforts for more than 6 hours

Exclusion Criteria:

  • Patients under 18 years;
  • Pregnant women;
  • Trauma or burns of the face that hinder the passage of gastro-esophageal catheter;
  • Nasal pathologies that prevent the progression of gastro-esophageal catheter;
  • Ulcers of the esophagus or stomach;
  • Documented esophageal varices;
  • Tracheostomized patients;
  • Instability of the chest wall or diaphragmatic injury;
  • Hemodynamic instability, defined as the need to increase vasoactive drugs in the last two hours in order to maintain the mean arterial pressure above 60 mmHg).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01519258

Contacts
Contact: Juliana C Ferreira, M.D. +55 11 83355876 juliana.ferreira@hc.fm.usp.br

Locations
Brazil
University of Sao Paulo General Hospital Recruiting
Sao Paulo, SP, Brazil, 05403-010
Contact: Juliana C Ferreira, MD       juliana.ferreira@hc.fm.usp.br   
Sponsors and Collaborators
University of Sao Paulo General Hospital
Fundação de Amparo à Pesquisa do Estado de São Paulo
Investigators
Principal Investigator: Juliana C Ferreira, M.D. University of Sao Paulo Medical School
  More Information

No publications provided

Responsible Party: University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT01519258     History of Changes
Other Study ID Numbers: 2011/20225-1 FAPESP
Study First Received: December 7, 2011
Last Updated: September 13, 2013
Health Authority: Brazil: CONEP (Comissão Nacional de Ética em Pesquisa)

Keywords provided by University of Sao Paulo General Hospital:
ARDS

Additional relevant MeSH terms:
Acute Lung Injury
Respiratory Distress Syndrome, Adult
Respiratory Distress Syndrome, Newborn
Syndrome
Disease
Infant, Newborn, Diseases
Infant, Premature, Diseases
Lung Diseases
Lung Injury
Pathologic Processes
Respiration Disorders
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on November 25, 2014