Comparison Between NAVA and PSV in Neurocritical Patients

NCT03721354 | Unknown

• 1 other identifier: CE 114/18
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Partial assisted mechanical ventilation modes are widely used to manage respiratory failure. It has been demonstrated that they can reduce complications related to mechanical ventilation and neuromuscular blocking agents administration. During partially assisted ventilation, there is no predefined respiratory rate and the patient must trigger each breath. One of the most used partial assisted mode is pressure support ventilation (PSV), which plays a key role in weaning from mechanical ventilation, especially in neuro-cranial diseases. Neurally adjusted ventilatory assist mode (NAVA) has been introduced in clinical practice in recent years. It has been widely demonstrated that NAVA is able to guarantee gas exchange in the same way as PSV in patients admitted to ICU for respiratory failure. Thus, NAVA can improve patient-ventilator interaction reducing the incidence of asynchronous events and favoring the patient's own ventilatory pattern. Nevertheless, NAVA does not appear to have been applied in neuro ICU patients. In a study conducted on non-neurosurgical infants has been demonstrated negative effects of asynchronous events on cerebral blood flow velocities, examined with transcranial Doppler technique. In the present pilot study, the investigators would like to compare NAVA and PSV ventilation influence on cranial blood flow, evaluated with Trans-Cranial Color Doppler, in patients admitted to ICU for neurological injuries.

Conditions

Neuro: Cerebrovascular Accident; Trauma, Head

Outcome Measures

Primary Outcomes (1)

• NAVA safety- Change in cranial blood flow velocity

  Ultrasound evaluation, using trans cranial doppler technique will be performed to evaluate the blood cerebral flow speed (average/systolic speed) near the point of emergency, in the middle tract and at the bifurcation of M1 bilaterally.

  After ventilatory modes is applied, a time range of 20 minutes will be considered necessary to assess cerebral blood flow. This evaluation will be performed over time range of 5-15 seconds (in any case the time of 3 doppler signal beats)

Secondary Outcomes (6)

• Gas exchange - arterial carbon dioxide tension

  After ventilatory modes is applied, a time range of 20 minutes will be considered necessary to assess arterial blood gas analysis. this evaluation will be run at the end of each trial for a total of 3 sample in 60 minutes.

• Gas exchange - pH

  After ventilatory modes is applied, a time range of 20 minutes will be considered necessary to assess arterial blood gas analysis. this evaluation will be run at the end of each trial for a total of

• Gas exchange - arterial oxygen tension

  After ventilatory modes is applied, a time range of 20 minutes will be considered necessary to assess arterial blood gas analysis. this evaluation will be run at the end of each trial for a total of 3 sample in 60 minutes.

• Patient-ventilator interaction 1

  After ventilatory modes is applied, a time range of 20 minutes will be considered necessary to assess arterial blood gas analysis. this evaluation will be run at the end of each trial for a total of 3 times per hour.

• Patient-ventilator interaction 2

  After ventilatory modes is applied, a time range of 20 minutes will be considered necessary to assess arterial blood gas analysis. this evaluation will be run at the end of each trial for a total of 3 times per hour.

Study Arms (1)

NAVA vs PSV -TCCD

EXPERIMENTAL

Ultrasound evaluation, using trans cranial doppler technique will be performed to evaluate the cerebral blood flow speed (average/systolic speed) near the point of emergency, in the middle tract and at the bifurcation of M1 bilaterally, at the end of every ventilation trial (NAVA and PSV).

Other: NAVA vs PSV - TCCD

Interventions

NAVA vs PSV - TCCD OTHER

Patients will be submitted to 3 different 30 minutes ventilation trials: the first one in PSV mode, the second one in NAVA mode and the third one in PSV mode again. PSV will have PEEP setted by clinician and pressure support set in order to obtain Vt 6-8 ml/kg. NAVA will have the same PEEP as PSV and NAVA level will be set to obtain the same Peak of Inspiratory Pressure) of PSV. Trans cranial doppler technique will be performed to evaluate the blood cerebral flow speed (average/systolic speed) at the end of every ventilation trial. At the end of each trial, ABGs will be performed. Traces of flow, airways pressure (Paw) and electric diaphragmatic activity (EAdi) will be recorded and acquired through a dedicated ventilator software called NAVA tracker.

NAVA vs PSV -TCCD

Eligibility Criteria

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

You may qualify if:

• Every ICU patient sedated and intubated, admitted for intracranial disease (neuromuscular disease and head trauma);
• intracranial pressure monitoring
• Mechanical ventilation for more than 48 hours
• Readiness for assisted mechanical ventilation at the screening

You may not qualify if:

• intracranial pressure instability more than 15 cmH2O;
• symptomatic vasospasm;
• average cerebral flow velocity at transcranial basal doppler in M1 more than 120 cm/sec
• hemodynamic instability;
• gastro-esophageal surgery in the previous 12 months;
• gastro-esophageal bleeding in the previous 30 days;
• history of esophageal varices;
• maxillofacial trauma or surgery;
• body temperature more than 38° C at the time of the study;
• coagulation disorders;
• PaCO2 not included in the basal range (between 35 and 45 mmHg) or paCo2 variation more than +/- 20% obtained in partially assisted mode compared to baseline;
• pregnancy;

Sponsors & Collaborators

• Azienda Ospedaliero Universitaria Maggiore della Carita: lead

Study Sites (1)

A.O.U Maggiore della Carità

Novara, 28100, Italy

RECRUITING

Related Publications (8)

• 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: 18367735 BACKGROUND

• Dekel B, Segal E, Perel A. Pressure support ventilation. Arch Intern Med. 1996 Feb 26;156(4):369-73.

  PMID: 8607722 BACKGROUND

• Cormio M, Portella G, Spreafico E, Mazza L, Pesenti A, Citerio G. [Role of assisted breathing in severe traumatic brain injury]. Minerva Anestesiol. 2002 Apr;68(4):278-84. Italian.

  PMID: 12024100 BACKGROUND

• Navalesi P, Longhini F. Neurally adjusted ventilatory assist. Curr Opin Crit Care. 2015 Feb;21(1):58-64. doi: 10.1097/MCC.0000000000000167.

  PMID: 25486574 BACKGROUND

• Colombo D, Cammarota G, Bergamaschi V, De Lucia M, Corte FD, Navalesi P. Physiologic response to varying levels of pressure support and neurally adjusted ventilatory assist in patients with acute respiratory failure. Intensive Care Med. 2008 Nov;34(11):2010-8. doi: 10.1007/s00134-008-1208-3. Epub 2008 Jul 16.

  PMID: 18629471 BACKGROUND

• Rennie JM, South M, Morley CJ. Cerebral blood flow velocity variability in infants receiving assisted ventilation. Arch Dis Child. 1987 Dec;62(12):1247-51. doi: 10.1136/adc.62.12.1247.

  PMID: 3324972 BACKGROUND

• Aaslid R. Transcranial Doppler assessment of cerebral vasospasm. Eur J Ultrasound. 2002 Nov;16(1-2):3-10. doi: 10.1016/s0929-8266(02)00045-9.

  PMID: 12470845 BACKGROUND

• Cammarota G, Verdina F, Lauro G, Boniolo E, Tarquini R, Messina A, De Vita N, Sguazzoti I, Perucca R, Corte FD, Vignazia GL, Grossi F, Crudo S, Navalesi P, Santangelo E, Vaschetto R. Neurally adjusted ventilatory assist preserves cerebral blood flow velocity in patients recovering from acute brain injury. J Clin Monit Comput. 2021 May;35(3):627-636. doi: 10.1007/s10877-020-00523-w. Epub 2020 May 9.

  PMID: 32388653 DERIVED

MeSH Terms

Conditions

Craniocerebral Trauma

Condition Hierarchy (Ancestors)

Trauma, Nervous System; Nervous System Diseases; Wounds and Injuries

Study Officials

• Gianmaria Cammarota, MD,PHD

  "Maggiore della Carità" Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gianmaria Cammarota, MD, PhD

CONTACT

00393392669420; gmcamma@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: the ultrasonography examiner is blind on the ventilatory mode
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: pilot interventional study

Study Record Dates

• First Submitted: October 18, 2018
• First Posted: October 26, 2018
• Study Start: November 1, 2018
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: November 19, 2019

Record last verified: 2019-07

Locations

IT (1)