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

Performance of NAVA as Lung Protective Mechanical Ventilation in Patients With Acute Respiratory Distress Syndrome

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01519258
Enrollment
20
Registered
2012-01-26
Start date
2012-10-31
Completion date
2015-12-31
Last updated
2019-04-03

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

Conditions

Acute Respiratory Distress Syndrome

Keywords

ARDS

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.

Interventions

OTHERPressure 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.

DEVICENAVA

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

Sponsors

Fundação de Amparo à Pesquisa do Estado de São Paulo
CollaboratorOTHER_GOV
University of Sao Paulo General Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
Tidal volume15 minTidal volume will be recorded breath by breath for 15 minutes

Secondary

MeasureTime frameDescription
respiratory rate15 minRespiratory rate will be recorded breath by breath for 15 minutes
Prolonged NAVA ventilation3 hourspatients 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

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 28, 2026