NAVA Unloading - Effects on Distribution of Ventilation

Acute Respiratory Failure Clinical Trial

Official title:

Reduced Unloading in NAVA Improves Distribution of Ventilation in ICU Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02711722
• Other study ID #: 2015/521-31/4
• Status: Recruiting
• Phase: N/A
• First received: March 14, 2016
• Last updated: April 14, 2016
• Start date: June 2015
• Est. completion date: September 2016

Study information

• Verified date: April 2016
• Source: Karolinska University Hospital
• Contact: Peter V Sackey, MD, PhD
• Phone: +46851772066
• Email: peter.sackey[@]karolinska.se
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial 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

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%).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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).

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Acute Respiratory Failure
• Respiratory Distress Syndrome, Adult
• Respiratory Insufficiency

Intervention

Device:
• 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.
• PScli1
Pressure support set by clinicians prior to inclusion
• PScli2
Pressure support at the same level as prior to the study

Locations

Country	Name	City	State
Sweden	Dept. Anesthesiology, Surgical Services and Intensive Care Medicine,Karolinska Univeristy Hospital	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska University Hospital

Country where clinical trial is conducted

Sweden, 

References & Publications (6)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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;19:43. doi: 10.1186/s13054-015-0775-2. — View Citation

Sinderby C, Navalesi P, Beck J, Skrobik Y, Comtois N, Friberg S, Gottfried SB, Lindström L. Neural control of mechanical ventilation in respiratory failure. Nat Med. 1999 Dec;5(12):1433-6. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Gas Exchange (PaO2 and PaCO2)	Comparison between study steps	During the last 5min of each study step (each 30min), total 5 steps. Total study time 2,5 hours	No
Secondary	Airway Pressure		2,5 hours	No
Secondary	Muscle unloading based on Neuro-Ventilatory Efficiency and Neuro-Mechanica Efficiency		2,5 hours	No