Mechanical Ventilation With Neurally-Adjusted Ventilatory Assist in Patients With ARDS
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01519258|
Recruitment Status : Completed
First Posted : January 26, 2012
Last Update Posted : April 3, 2019
- Study Details
- Tabular View
- No Results Posted
- How to Read a Study Record
|Condition or disease||Intervention/treatment||Phase|
|Acute Respiratory Distress Syndrome||Other: Pressure Support ventilation Device: NAVA||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||Performance of NAVA as Lung Protective Mechanical Ventilation in Patients With Acute Respiratory Distress Syndrome|
|Study Start Date :||October 2012|
|Actual Primary Completion Date :||November 2015|
|Actual Study Completion Date :||December 2015|
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.
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.
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.
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
- Tidal volume [ Time Frame: 15 min ]Tidal volume will be recorded breath by breath for 15 minutes
- 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
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, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years to 90 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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
- 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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01519258
|University of Sao Paulo General Hospital|
|Sao Paulo, SP, Brazil, 05403-010|
|Principal Investigator:||Juliana C Ferreira, M.D.||University of Sao Paulo Medical School|
|Responsible Party:||University of Sao Paulo General Hospital|
|Other Study ID Numbers:||
|First Posted:||January 26, 2012 Key Record Dates|
|Last Update Posted:||April 3, 2019|
|Last Verified:||April 2019|
Respiratory Distress Syndrome
Respiratory Distress Syndrome, Newborn
Acute Lung Injury
Respiratory Tract Diseases
Infant, Premature, Diseases
Infant, Newborn, Diseases