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

NCT01519258 | Completed

• 1 other identifier: 2011/20225-1 FAPESP
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Respiratory Distress Syndrome

Keywords

ARDS

Outcome Measures

Primary Outcomes (1)

• Tidal volume

  Tidal volume will be recorded breath by breath for 15 minutes

  15 min

Secondary Outcomes (2)

• respiratory rate

  15 min

• Prolonged NAVA ventilation

  3 hours

Study Arms (2)

PSV

ACTIVE COMPARATOR

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.

Other: Pressure Support ventilation

NAVA

EXPERIMENTAL

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.

Device: NAVA

Interventions

Pressure Support ventilation OTHER

Patients will receive usual care during the period of ventilation on the Pressure Support. The same ventilator, the Servoi (maquet, Sweden) will be used.

PSV

NAVA DEVICE

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

NAVA

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator

Study Sites (1)

University of Sao Paulo General Hospital

São Paulo, São Paulo, 05403-010, Brazil

Location

Related Publications (1)

• 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.

  PMID: 32040785 DERIVED

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Study Officials

• Juliana C Ferreira, M.D.

  University of Sao Paulo Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2011
• First Posted: January 26, 2012
• Study Start: October 1, 2012
• Primary Completion: November 1, 2015
• Study Completion: December 1, 2015
• Last Updated: April 3, 2019

Record last verified: 2019-04

Locations

BR (1)