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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by King's College Hospital NHS Trust
Sponsor:
Collaborator:
Guy's and St Thomas' NHS Foundation Trust
Information provided by (Responsible Party):
King's College Hospital NHS Trust
ClinicalTrials.gov Identifier:
NCT01826890
First received: April 4, 2013
Last updated: June 26, 2013
Last verified: April 2013
  Purpose

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 Intervention
Adults With Cardiopulmonary Disease at Risk of Prolonged Weaning From Mechanical Ventilation
Other: NAVA Technology

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by King's College Hospital NHS Trust:

Primary Outcome Measures:
  • Ventilator Free Days [ Time Frame: 28 days ] [ Designated as safety issue: No ]

    The number of calendar days from initiating unassisted breathing to day 28 after randomisation, assuming survival for at least 48 hours after initiating unassisted breathing and continued unassisted breathing to day 28.

    If unassisted breathing is achieved twice prior to day 28, VFDs will be counted from the end of the last period to day 28. Short periods of assisted breathing (<24 hours) will not count against the VFD calculation. Where assisted breathing occurs at day 27 or death occurs prior to day 28, without 48 consecutive hours of unassisted breathing following termination of assisted breathing, VFDs will be 0.

    Unassisted breathing:

    1. Extubated with supplemental oxygen or room air
    2. Open T-tube breathing
    3. Tracheostomy mask breathing
    4. CPAP less than or equal to 5 cm H20 without pressure support

    Patients receiving pressure support via non-invasive ventilation will be defined as receiving assisted ventilation, except where CPAP/BIPAP is used at night.



Estimated Enrollment: 92
Study Start Date: May 2013
Estimated Study Completion Date: March 2017
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

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
  • 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01826890

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

Locations
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
Investigators
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

No publications provided

Responsible Party: King's College Hospital NHS Trust
ClinicalTrials.gov Identifier: NCT01826890     History of Changes
Other Study ID Numbers: 13/LO/0012
Study First Received: April 4, 2013
Last Updated: June 26, 2013
Health Authority: United Kingdom: National Health Service

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

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

ClinicalTrials.gov processed this record on July 24, 2014