NAVA Unloading - Effects on Distribution of Ventilation

NCT ID: NCT02711722

Last Updated: 2016-04-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-06-30
• Study Completion Date: 2016-09-30

Brief Summary

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

Objectives:

1. To investigate if NAVA targeted to moderate respiratory muscular unloading results in redistribution of ventilation to the dorsal regions of the lungs

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. To verify the possibility to set NAVA at different levels of unloading, based on Neuro-Ventilatory Efficiency.

Study Design: Randomised Crossover of Pressure Support and NAVA at different levels of unloading.

Population: Adult Intubated patients at the Neurosurgical ICU, ventilated for more than 48h, in weaning phase from mechanical ventilation.

Study duration: 2,5h Number of subjects: 12

Detailed Description

Critically ill patients on mechanical ventilation are at risk for developing respiratory muscle atrophy. Partial Assist modes such Pressure Support (PS) and Neurally Adjusted Ventilatory Assist (NAVA) are developed to maintain patients´own effort in breathing. However there are no recommendations on how to set the optimal ventilator support in NAVA to avoid over- or underassistance.

A previous Electrical Impedance Thomography (EIT) study has shown a redistribution of ventilation towards the dorsal regions of the lung in acute lung injury patients ventilated with NAVA, compared to PS.

In the present study, the assist is targeted to different respiratory muscle unloading, predefined and based on the Neuro-Ventilatory Efficiency (NVE). The NVE will be measured at 10min intervals and NAVA level adjusted if needed, to keep constant the level of unloading in each study step.

Protocol: Once enrolled, the patients are ventilated in PS (PScli1) as set by the clinician. They are then ventilated in NAVA at 3 different levels of muscle unloading in randomized order. At NAVAcli, the assist level matches to PScli1 in terms of muscle unloading. With NAVA40% and NAVA60%, the patients have 40% and 60% unloading, respectively. In the last study step the patients are back to PS (PScli2). Each patient is his/her own control and goes through the 5 ventilation periods, of 30min each. In the last 5 min of each study step, the CoV (obtained through the EIT data), blood gas samples (for oxygenation and ventilation) and ventilatory parameters are obtained and analyzed.

The investigators hypothesize that

1. It is possible to set NAVA at different levels of unloading, based on NVE.

2. Moderate muscle unloading (corresponding to NAVA40%) keeps the diaphragm active and thereby leads to more dorsal distribution of ventilation compared to PScli and to higher unloading in NAVA.

3. Secondarily and as a consequence of the redistribution of ventilation, we hypothesize that the gas exchange will remain unchanged or will improve and that the airway pressures will decrease for moderate unloading (NAVA40%).

Conditions

Acute Respiratory Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

PScli1

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

Group Type: ACTIVE_COMPARATOR

PScli1

Intervention Type: DEVICE

Pressure support set by clinicians prior to inclusion

NAVAcli

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.

Group Type: ACTIVE_COMPARATOR

Neurally adjusted ventilatory assist

Intervention Type: DEVICE

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.

NAVA40%

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.

Group Type: ACTIVE_COMPARATOR

Neurally adjusted ventilatory assist

Intervention Type: DEVICE

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.

NAVA60%

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.

Group Type: ACTIVE_COMPARATOR

Neurally adjusted ventilatory assist

Intervention Type: DEVICE

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.

PScli2

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

Group Type: ACTIVE_COMPARATOR

PScli2

Intervention Type: DEVICE

Pressure support at the same level as prior to the study

Interventions

Neurally adjusted ventilatory assist

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.

Intervention Type: DEVICE

PScli1

Pressure support set by clinicians prior to inclusion

Intervention Type: DEVICE

PScli2

Pressure support at the same level as prior to the study

Intervention Type: DEVICE

Other Intervention Names

NAVA; Pressure support; Pressure support

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Karolinska University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Peter Sackey

Associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Peter V Sackey, MD, PhD

Role: STUDY_CHAIR

Karolinska University Hospital

Francesca Campoccia Jalde, MD

Role: PRINCIPAL_INVESTIGATOR

Karolinska University Hospital

Locations

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

Stockholm, , Sweden

Site Status: RECRUITING

Countries

Sweden

Central Contacts

Peter V Sackey, MD, PhD

Role: CONTACT

peter.sackey@karolinska.se

+46851772066

Francesca Campoccia Jalde, MD

Role: CONTACT

francesca.campoccia-jalde@karolinska.se

0046703947741

Facility Contacts

Francesca Campoccia Jalde, MD

Role: primary

francesca.campoccia-jalde@karolinska.se

0046703947741

Peter V Sackey, MD, PhD

Role: backup

peter.sackey@karolinska.se

+46851772066

References

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.

Reference Type: BACKGROUND

PMID: 18367735 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 10581089 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23553568 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22849707 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22584798 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25882607 (View on PubMed)

Other Identifiers

2015/521-31/4

Identifier Type: -

Identifier Source: org_study_id