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

Primary Purpose

Acute Respiratory Distress Syndrome

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Pressure Support ventilation
NAVA
Sponsored by
University of Sao Paulo General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Respiratory Distress Syndrome focused on measuring ARDS

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • University of Sao Paulo General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

PSV

NAVA

Arm Description

Patients will be ventilated with the a conventional mode of ventilation called Pressure Support Ventilation (PSV) for 15 minutes. Mechanical ventilator settings will be set to match the tidal volume applied by the ICU team, in accordance to current standard of care recommendations.

Patients will be ventilated with NAVA for 15 minutes. Nava level will be titrated prior to randomization, to deliver the same peak of airway pressure obtained with the active comparator, PSV. The resulting tidal volume should match the tidal volume applied by the ICU team, in accordance to current standard of care recommendations.

Outcomes

Primary Outcome Measures

Tidal volume
Tidal volume will be recorded breath by breath for 15 minutes

Secondary Outcome Measures

respiratory rate
Respiratory rate will be recorded breath by breath for 15 minutes
Prolonged NAVA ventilation
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

Full Information

First Posted
December 7, 2011
Last Updated
April 1, 2019
Sponsor
University of Sao Paulo General Hospital
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT01519258
Brief Title
Mechanical Ventilation With Neurally-Adjusted Ventilatory Assist in Patients With ARDS
Official Title
Performance of NAVA as Lung Protective Mechanical Ventilation in Patients With Acute Respiratory Distress Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Sao Paulo General Hospital
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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 from 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Respiratory Distress Syndrome
Keywords
ARDS

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PSV
Arm Type
Active Comparator
Arm Description
Patients will be ventilated with the a conventional mode of ventilation called Pressure Support Ventilation (PSV) for 15 minutes. Mechanical ventilator settings will be set to match the tidal volume applied by the ICU team, in accordance to current standard of care recommendations.
Arm Title
NAVA
Arm Type
Experimental
Arm Description
Patients will be ventilated with NAVA for 15 minutes. Nava level will be titrated prior to randomization, to deliver the same peak of airway pressure obtained with the active comparator, PSV. The resulting tidal volume should match the tidal volume applied by the ICU team, in accordance to current standard of care recommendations.
Intervention Type
Other
Intervention Name(s)
Pressure Support ventilation
Intervention Description
Patients will receive usual care during the period of ventilation on the Pressure Support. The same ventilator, the Servoi (maquet, Sweden) will be used.
Intervention Type
Device
Intervention Name(s)
NAVA
Intervention Description
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
Primary Outcome Measure Information:
Title
Tidal volume
Description
Tidal volume will be recorded breath by breath for 15 minutes
Time Frame
15 min
Secondary Outcome Measure Information:
Title
respiratory rate
Description
Respiratory rate will be recorded breath by breath for 15 minutes
Time Frame
15 min
Title
Prolonged NAVA ventilation
Description
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
Time Frame
3 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juliana C Ferreira, M.D.
Organizational Affiliation
University of Sao Paulo Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Sao Paulo General Hospital
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
05403-010
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
32040785
Citation
Diniz-Silva F, Moriya HT, Alencar AM, Amato MBP, Carvalho CRR, Ferreira JC. Neurally adjusted ventilatory assist vs. pressure support to deliver protective mechanical ventilation in patients with acute respiratory distress syndrome: a randomized crossover trial. Ann Intensive Care. 2020 Feb 10;10(1):18. doi: 10.1186/s13613-020-0638-0.
Results Reference
derived

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

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