We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

Neurally Adjusted Ventilatory Assist in Adults at Risk of Delayed Weaning From Mechanical Ventilation (RESTUS)

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: NCT01826890
Recruitment Status : Unknown
Verified April 2013 by King's College Hospital NHS Trust.
Recruitment status was:  Recruiting
First Posted : April 9, 2013
Last Update Posted : December 8, 2016
Information provided by (Responsible Party):

Study Description
Brief Summary:
Many patients admitted to intensive care have heart or lung problems. Patients with these conditions often require longer durations of support from breathing machines. Survival and long-term recovery are improved if the investigators can remove the breathing support quickly. In this study, the investigators will focus on patients with severe lung or heart disease to examine whether a particular type of breathing machine (NAVA ventilator) will allow us to remove breathing support more quickly and with less need for sedative medications, when compared to current practice.

Condition or disease Intervention/treatment
Adults With Cardiopulmonary Disease at Risk of Prolonged Weaning From Mechanical Ventilation Other: NAVA Technology

  Show Detailed Description

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 76 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A Randomised Feasibility Study Examining Neurally-adjusted Ventilatory Assist (NAVA) in Patients at High Risk of Prolonged Ventilatory Failure During Recovery From Critical Illness.
Study Start Date : May 2013
Estimated Primary Completion Date : October 2017
Estimated Study Completion Date : January 2018
Arms and Interventions

Arm Intervention/treatment
Experimental: NAVA technology
Following randomisation, a NAVA catheter will be introduced. The Electrical Activity of the Diaphragm (EAdi) will be viewed primarily to ensure a minimum level of diaphragm activation during the weaning phase. NAVA mode suitability/safety assessments will be conducted in all patients prior to the first initiation of the NAVA mode. The NAVA preview function on the Maquet Servo-i ventilators will be used to transfer from the previous mode to the NAVA mode, and the assessment will last for a maximum of 30 minutes. We are recommending the use of the NAVA ventilation mode during the weaning period. Following the commencement of weaning, sedation holds and spontaneous breathing trials will be conducted according to local protocols.
Other: NAVA Technology
Use of NAVA technology: Diaphragmatic monitoring and NAVA ventilation mode
Other Names:
  • Neurally Adjusted Ventilatory Assist
  • NAVA
No Intervention: Standard Care
A NAVA catheter will be inserted following randomisation. The NAVA capabilities of the ventilator will be disabled. Patients will be ventilated according to local weaning protocol as per current standard care with either Pressure Support, Synchronised Intermittent Mandatory Ventilation, Volume Controlled Ventilation, Pressure Controlled Ventilation or Pressure Regulated Volume Controlled Ventilation. Following the commencement of weaning, sedation holds and spontaneous breathing trials will be conducted according to local protocols.

Outcome Measures

Primary Outcome Measures :
  1. Protocol compliance [ Time Frame: 28 days ]
    Total time in the NAVA ventilation mode as a proportion of total time in an assisted spontaneous weaning ventilation mode within 28 days from randomisation.

Eligibility Criteria

Information from the National Library of Medicine

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 and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

ICU admissions who are likely to remain intubated and ventilated for greater than 48 hours with a diagnosis of one or a combination of:

  1. COPD
  2. Left and/or right ventricular heart failure
  3. Mild, moderate or severe (Berlin criteria) Acute Respiratory Distress Syndrome (ARDS)

All diagnoses must be documented in the medical notes. There must be evidence of a specialist consultant diagnosis, or a non-specialist doctor diagnosis with either objective test results (spirometry, CT, lung biopsy, cardiac echo) and/or prescribed treatment.

Exclusion Criteria:

  • Less than 18 years old or pregnant
  • Inability to conduct protocol (e.g. research staff or NAVA technology unavailable)
  • No personal or nominated consultee available or assent declined
  • Greater than 96 hours from intubation
  • Greater than 24 hours in the weaning phase
  • Patient likely to die/have treatment withdrawal within 48 hours
  • Contraindication to passing NG tube
  • Patients with primary neurological cause of ventilator dependence
  • High spinal injury above C6; severe traumatic brain injury (Glasgow Coma Score < 8)
  • Suspected or proven hypoxic brain injury
  • Physician refusal / physician wishes to use NAVA
  • Hepatic encephalopathy greater than grade one
  • Domiciliary ventilation (except CPAP/BIPAP used for sleep disordered breathing)
  • Enrollment in another interventional clinical trial in the last 30 days
  • Non-English speakers where inadequate translation available to allow informed consent
Contacts and Locations

Information from the National Library of Medicine

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): NCT01826890

Contact: Daniel J Hadfield 0044 (0) 0232992080 daniel.hadfield@nhs.net
Contact: Philip A Hopkins 0044 (0) 20 3299 4957 p.hopkins@nhs.net

United Kingdom
King's College Hospital NHS Foundation Trust Recruiting
London, United Kingdom, SE5 9RS
Contact: Daniel J Hadfield    020 3299 2080    daniel.hadfield@nhs.net   
Sponsors and Collaborators
King's College Hospital NHS Trust
Guy's and St Thomas' NHS Foundation Trust
King's College London
National Institute for Health Research, United Kingdom
The Moulton Foundation
Principal Investigator: Daniel J Hadfield King's College Hospital NHS Trust
Study Chair: Phillip A Hopkins King's College Hopspital NHS Foundation Trust
Study Director: Nicholas Hart Guy's and St Thomas' NHS Foundation Trust
Study Director: Gerrard F Rafferty King's College Hospital NHS Trust
More Information

Responsible Party: King's College Hospital NHS Trust
ClinicalTrials.gov Identifier: NCT01826890     History of Changes
Other Study ID Numbers: 13/LO/0012
First Posted: April 9, 2013    Key Record Dates
Last Update Posted: December 8, 2016
Last Verified: April 2013

Keywords provided by King's College Hospital NHS Trust:
Ventilator Weaning
Mechanical Ventilation
Critical Care
Neurally Adjusted Ventilatory Assist

Additional relevant MeSH terms:
Pulmonary Heart Disease
Heart Diseases
Cardiovascular Diseases