NCT02711722

Brief Summary

Title: Reduced Unloading in NAVA Improves distribution of Ventilation in ICU patients. Objectives:

  1. 1.To investigate if NAVA targeted to moderate respiratory muscular unloading results in redistribution of ventilation to the dorsal regions of the lungs
  2. 2.To verify if the redistribution of ventilation translates to a better gas exchange and to a potentially lung protective ventilation strategy (lower airway pressures)
  3. 3.To verify the possibility to set NAVA at different levels of unloading, based on Neuro-Ventilatory Efficiency.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2015

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

March 14, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 17, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

April 15, 2016

Status Verified

April 1, 2016

Enrollment Period

1.3 years

First QC Date

March 14, 2016

Last Update Submit

April 14, 2016

Conditions

Acute Respiratory Failure

Keywords

Neurally adjusted ventilatory assist

Outcome Measures

Primary Outcomes (1)

  • Center of Ventilation (CoV), expressed in percent (ventral to dorsal)

    The distribution of ventilation is summarized by the CoV, a parameter obtained by the EIT monitor. Recordings are made at the end of each study step (total 5), lasting 30min.

    Total study time is 2,5 hours

Secondary Outcomes (3)

  • Gas Exchange (PaO2 and PaCO2)

    During the last 5min of each study step (each 30min), total 5 steps. Total study time 2,5 hours

  • Airway Pressure

    2,5 hours

  • Muscle unloading based on Neuro-Ventilatory Efficiency and Neuro-Mechanica Efficiency

    2,5 hours

Study Arms (5)

PScli1

ACTIVE COMPARATOR

Patients are ventilated in Pressure support (PS) according to the Clinical settings for 30min.

Device: PScli1

NAVAcli

ACTIVE COMPARATOR

Patients are ventilated in Neurally Adjusted Ventilatory Assist (NAVA) and the assist is set in order to match to respiratory muscle unloading reached with PScli1. Patients are ventilated in NAVAcli for 30min.

Device: Neurally adjusted ventilatory assist

NAVA40%

ACTIVE COMPARATOR

Patients are ventilated in Neurally Adjusted Ventilatory Assist (NAVA) and the assist is set in order to target 40% muscle unloading based on the Neuro-Ventilatory Efficiency (NVE) measurement. Patients are ventilated in NAVA40% for 30min.

Device: Neurally adjusted ventilatory assist

NAVA60%

ACTIVE COMPARATOR

Patients are ventilated in Neurally Adjusted Ventilatory Assist (NAVA) and the assist is set in order to target 60% muscle unloading based on the Neuro-Ventilatory Efficiency (NVE) measurement. Patients are ventilated in NAVA60% for 30min.

Device: Neurally adjusted ventilatory assist

PScli2

ACTIVE COMPARATOR

Patients return to PS ventilation, according to the Clinical settings as in PScli1 for 30min.

Device: PScli2

Interventions

Neurally adjusted ventilatory assistDEVICE

Ventilation supported by NAVA * Blood gas analysis * Respiratory Parameters At the end of the study step Neuro-Ventilatory Efficiency and Neuro-Mechanical Efficiency are measured.

Also known as: NAVA
NAVA40%NAVA60%NAVAcli
PScli1DEVICE

Pressure support set by clinicians prior to inclusion

Also known as: Pressure support
PScli1
PScli2DEVICE

Pressure support at the same level as prior to the study

Also known as: Pressure support
PScli2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients belonging to Neurosurgical ICU
  • Intubated for ≥48h
  • Weaning phase from Mechanical Ventilation

You may not qualify if:

  • bleeding disorders (PK INR\>1,5 or APTT\>50s or platelet count \<50000/µL) or
  • unstable intracranial pressure (ICP\>20 mmHg during the latest 8 hours) or
  • unstable circulation (requiring high vasopressor dose, for example Noradrenalin \>0,2µg/kg/min) or
  • too severe lung disease (PFI ≤ 26,7 kPa or PEEP \>10 cmH2O or FiO2\>0,5 at study entry point) or
  • fever\> 38,5°C or
  • tendency to hyperventilation (PaCO2 \< 4,5 kPa at study entry point).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept. Anesthesiology, Surgical Services and Intensive Care Medicine,Karolinska Univeristy Hospital

Stockholm, 17176, Sweden

RECRUITING

Related Publications (6)

  • Levine S, Nguyen T, Taylor N, Friscia ME, Budak MT, Rothenberg P, Zhu J, Sachdeva R, Sonnad S, Kaiser LR, Rubinstein NA, Powers SK, Shrager JB. Rapid disuse atrophy of diaphragm fibers in mechanically ventilated humans. N Engl J Med. 2008 Mar 27;358(13):1327-35. doi: 10.1056/NEJMoa070447.

    PMID: 18367735BACKGROUND

  • Sinderby C, Navalesi P, Beck J, Skrobik Y, Comtois N, Friberg S, Gottfried SB, Lindstrom L. Neural control of mechanical ventilation in respiratory failure. Nat Med. 1999 Dec;5(12):1433-6. doi: 10.1038/71012. No abstract available.

    PMID: 10581089BACKGROUND

  • Blankman P, Hasan D, van Mourik MS, Gommers D. Ventilation distribution measured with EIT at varying levels of pressure support and Neurally Adjusted Ventilatory Assist in patients with ALI. Intensive Care Med. 2013 Jun;39(6):1057-62. doi: 10.1007/s00134-013-2898-8. Epub 2013 Apr 4.

    PMID: 23553568BACKGROUND

  • Liu L, Liu H, Yang Y, Huang Y, Liu S, Beck J, Slutsky AS, Sinderby C, Qiu H. Neuroventilatory efficiency and extubation readiness in critically ill patients. Crit Care. 2012 Jul 31;16(4):R143. doi: 10.1186/cc11451.

    PMID: 22849707BACKGROUND

  • Grasselli G, Beck J, Mirabella L, Pesenti A, Slutsky AS, Sinderby C. Assessment of patient-ventilator breath contribution during neurally adjusted ventilatory assist. Intensive Care Med. 2012 Jul;38(7):1224-32. doi: 10.1007/s00134-012-2588-y. Epub 2012 May 15.

    PMID: 22584798BACKGROUND

  • Liu L, Liu S, Xie J, Yang Y, Slutsky AS, Beck J, Sinderby C, Qiu H. Assessment of patient-ventilator breath contribution during neurally adjusted ventilatory assist in patients with acute respiratory failure. Crit Care. 2015 Feb 18;19(1):43. doi: 10.1186/s13054-015-0775-2.

    PMID: 25882607BACKGROUND

MeSH Terms

Interventions

Interactive Ventilatory Support

Intervention Hierarchy (Ancestors)

Respiration, ArtificialAirway ManagementTherapeuticsRespiratory Therapy

Study Officials

  • Peter V Sackey, MD, PhD

    Karolinska University Hospital

    STUDY CHAIR

  • Francesca Campoccia Jalde, MD

    Karolinska University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Peter V Sackey, MD, PhD

CONTACT

+46851772066peter.sackey@karolinska.se

Francesca Campoccia Jalde, MD

CONTACT

0046703947741francesca.campoccia-jalde@karolinska.se

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

March 14, 2016

First Posted

March 17, 2016

Study Start

June 1, 2015

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

April 15, 2016

Record last verified: 2016-04

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)