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

• ClinicalTrials.gov Identifier: NCT01519258
• Recruitment Status: Completed
• First Posted: January 26, 2012
• Last Update Posted: April 3, 2019
• Sponsor: University of Sao Paulo General Hospital
• Collaborator: Fundação de Amparo à Pesquisa do Estado de São Paulo
• Information provided by (Responsible Party): University of Sao Paulo General Hospital

Tracking Information

• First Submitted Date: December 7, 2011
• First Posted Date: January 26, 2012
• Last Update Posted Date: April 3, 2019
• Study Start Date: October 2012
• Actual Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 13, 2012)

Tidal volume [ Time Frame: 15 min ]

Tidal volume will be recorded breath by breath for 15 minutes

Original Primary Outcome Measures (submitted: January 23, 2012)

Tidal volume [ Time Frame: 3 hours ]

Tidal volume will be recorded breath by breath for 3 minutes every 15 minutes during the entire study

Current Secondary Outcome Measures (submitted: March 13, 2012)

• respiratory rate [ Time Frame: 15 min ]
  Respiratory rate will be recorded breath by breath for 15 minutes
• Prolonged NAVA ventilation [ Time Frame: 3 hours ]
  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

Original Secondary Outcome Measures (submitted: January 23, 2012)

respiratory rate [ Time Frame: 3 hours ]

Respiratory rate will be recorded breath by breath for 3 minutes every 15 minutes during the entire study

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Acute Respiratory Distress Syndrome

Intervention

• 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.
• Device: 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

Study Arms

• Active Comparator: PSV
  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.
  Intervention: Other: Pressure Support ventilation
• Experimental: NAVA
  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: Device: NAVA

• Publications *: 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: January 23, 2012): 20
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: December 2015
• Actual Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)

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).

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 90 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Brazil

Administrative Information

• NCT Number: NCT01519258
• Other Study ID Numbers: 2011/20225-1 FAPESP
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: University of Sao Paulo General Hospital
• Original Responsible Party: Same as current
• Current Study Sponsor: University of Sao Paulo General Hospital
• Original Study Sponsor: Same as current
• Collaborators: Fundação de Amparo à Pesquisa do Estado de São Paulo

Investigators

• Principal Investigator: Juliana C Ferreira, M.D.; University of Sao Paulo Medical School

• PRS Account: University of Sao Paulo General Hospital
• Verification Date: April 2019