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

NCT01826890 | Completed DMC

• 1 other identifier: 13/LO/0012
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

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.

Conditions

Adults With Cardiopulmonary Disease at Risk of Prolonged Weaning From Mechanical Ventilation

Keywords

Ventilator Weaning; Mechanical Ventilation; Critical Care; Neurally Adjusted Ventilatory Assist; Diaphragm

Outcome Measures

Primary Outcomes (1)

• Protocol compliance

  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.

  28 days

Study Arms (2)

NAVA technology

EXPERIMENTAL

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

Standard Care

NO INTERVENTION

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.

Interventions

NAVA Technology OTHER

Use of NAVA technology: Diaphragmatic monitoring and NAVA ventilation mode

Also known as: Neurally Adjusted Ventilatory Assist, NAVA

NAVA technology

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ICU admissions who are likely to remain intubated and ventilated for greater than 48 hours with a diagnosis of one or a combination of:
• COPD
• Left and/or right ventricular heart failure
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• King's College Hospital NHS Trust: lead
• Guy's and St Thomas' NHS Foundation Trust: collaborator
• King's College London: collaborator
• National Institute for Health Research, United Kingdom: collaborator
• JP Moulton Charitable Foundation: collaborator

Study Sites (1)

King's College Hospital NHS Foundation Trust

London, SE5 9RS, United Kingdom

Location

Related Publications (1)

• Hadfield DJ, Rose L, Reid F, Cornelius V, Hart N, Finney C, Penhaligon B, Molai J, Harris C, Saha S, Noble H, Clarey E, Thompson L, Smith J, Johnson L, Hopkins PA, Rafferty GF. Neurally adjusted ventilatory assist versus pressure support ventilation: a randomized controlled feasibility trial performed in patients at risk of prolonged mechanical ventilation. Crit Care. 2020 May 14;24(1):220. doi: 10.1186/s13054-020-02923-5.

  PMID: 32408883 DERIVED

MeSH Terms

Interventions

Interactive Ventilatory Support

Intervention Hierarchy (Ancestors)

Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Daniel J Hadfield

  King's College Hospital NHS Trust

  PRINCIPAL INVESTIGATOR

• Phillip A Hopkins

  King's College Hopspital NHS Foundation Trust

  STUDY CHAIR

• Nicholas Hart

  Guy's and St Thomas' NHS Foundation Trust

  STUDY DIRECTOR

• Gerrard F Rafferty

  King's College Hospital NHS Trust

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: April 4, 2013
• First Posted: April 9, 2013
• Study Start: May 1, 2013
• Primary Completion: March 1, 2018
• Study Completion: March 1, 2018
• Last Updated: March 25, 2019

Record last verified: 2019-03

Locations

GB (1)