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Comparison Between NAVA and PSV in Neurocritical Patients (NAVAPSVHEAD)

Primary Purpose

Neuro: Cerebrovascular Accident, Trauma, Head

Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
NAVA vs PSV - TCCD
Sponsored by
Azienda Ospedaliero Universitaria Maggiore della Carita
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neuro: Cerebrovascular Accident

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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;
  • inclusion in other research projects;

Sites / Locations

  • A.O.U Maggiore della CaritàRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

NAVA vs PSV -TCCD

Arm Description

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).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Gas exchange - arterial carbon dioxide tension
PaCO2, will be obtained performing ABG sample
Gas exchange - pH
pH will be obtained performing ABGs.
Gas exchange - arterial oxygen tension
arterial oxygenation PaO2 will be obtained performing ABGs.
Patient-ventilator interaction 1
trigger delay (msec)
Patient-ventilator interaction 2
synchronous events (total number of asynchrony events) and asynchrony index.
Patient-ventilator interaction 3
asynchrony index (total number of asynchrony events on respiratory rate *100)

Full Information

First Posted
October 18, 2018
Last Updated
November 17, 2019
Sponsor
Azienda Ospedaliero Universitaria Maggiore della Carita
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1. Study Identification

Unique Protocol Identification Number
NCT03721354
Brief Title
Comparison Between NAVA and PSV in Neurocritical Patients
Acronym
NAVAPSVHEAD
Official Title
Comparison Between NAVA and PSV in Neurocritical Patients: a Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Unknown status
Study Start Date
November 1, 2018 (Actual)
Primary Completion Date
December 31, 2019 (Anticipated)
Study Completion Date
December 31, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Azienda Ospedaliero Universitaria Maggiore della Carita

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
The aim of this pilot study is to compare NAVA and PSV in order to establish their influence on cranial blood flow, assessed in the mean cerebral artery (M1 tract bilaterally). Secondarily, it will be evaluated the effectiveness in guaranteeing the gas exchange and patient-ventilator interaction during each ventilation mode. Patients will be evaluated in order to establish their readiness for assisted mechanical ventilation. The following clinical criteria must be respected: a heart rate of less than 120 bpm, blood pressure between 90 and 180 mmHg; dopamine/dobutamine less than 5 mcg/kg/minute, norepinephrine less than 0.25 mcg/kg/min; PaO2/FiO2 > 150; PEEP (positive end-expiratory pressure) minor or equal to 10 cmH2O; Vt between 6 and 8 ml/kg; respiratory rate less than 35 breaths per minutes and without respiratory distress signs; blood pH between 7.35 and 7.45; Afterward, patients will be submitted to three different mechanical ventilation trials in partially assisted modes: the first one in PSV mode, the second one in NAVA mode and the third one in PSV mode again. Each trial will last 30 minutes. PSV will have PEEP set by clinician and pressure support will be set in order to obtain Vt between 6 and 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. The expiratory trigger will be adjusted to the 50% of the inspiratory flow peak in PSV. During NAVA, the expiratory trigger is fixed to 75% of diaphragmatic electrical activity. The inspiratory fraction of oxygen (FiO2) will be set in order to obtain a peripheral oxygen saturation of more than 94%. Ultrasound evaluation, using transcranial Doppler technique will be performed to evaluate the cerebral blood flow speed (average/systolic speed) near the point of emergency, in the middle length and at the bifurcation of M1 bilaterally, at the end of every ventilation trial. At the end of each trial, PaCO2, Ph and blood oxygenation (PaO2) will be obtained performing ABGs. Moreover, traces of flow, airways pressure (Paw) and electric diaphragmatic activity (EAdi) will be recorded and acquired through a dedicated ventilator software called NAVA tracker. This will allow evaluating the patient-ventilator interaction (trigger delay, asynchronous events, and asynchrony index).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuro: Cerebrovascular Accident, Trauma, Head

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
pilot interventional study
Masking
None (Open Label)
Masking Description
the ultrasonography examiner is blind on the ventilatory mode
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
NAVA vs PSV -TCCD
Arm Type
Experimental
Arm Description
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).
Intervention Type
Other
Intervention Name(s)
NAVA vs PSV - TCCD
Intervention Description
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.
Primary Outcome Measure Information:
Title
NAVA safety- Change in cranial blood flow velocity
Description
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.
Time Frame
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 Outcome Measure Information:
Title
Gas exchange - arterial carbon dioxide tension
Description
PaCO2, will be obtained performing ABG sample
Time Frame
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.
Title
Gas exchange - pH
Description
pH will be obtained performing ABGs.
Time Frame
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
Title
Gas exchange - arterial oxygen tension
Description
arterial oxygenation PaO2 will be obtained performing ABGs.
Time Frame
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.
Title
Patient-ventilator interaction 1
Description
trigger delay (msec)
Time Frame
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.
Title
Patient-ventilator interaction 2
Description
synchronous events (total number of asynchrony events) and asynchrony index.
Time Frame
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.
Title
Patient-ventilator interaction 3
Description
asynchrony index (total number of asynchrony events on respiratory rate *100)
Time Frame
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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; inclusion in other research projects;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gianmaria Cammarota, MD, PhD
Phone
00393392669420
Email
gmcamma@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gianmaria Cammarota, MD,PHD
Organizational Affiliation
"Maggiore della Carità" Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
A.O.U Maggiore della Carità
City
Novara
ZIP/Postal Code
28100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gianmaria Cammarota, MD,PhD
Phone
003903213733406
Email
gmcamma@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
18367735
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.
Results Reference
background
PubMed Identifier
8607722
Citation
Dekel B, Segal E, Perel A. Pressure support ventilation. Arch Intern Med. 1996 Feb 26;156(4):369-73.
Results Reference
background
PubMed Identifier
12024100
Citation
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.
Results Reference
background
PubMed Identifier
25486574
Citation
Navalesi P, Longhini F. Neurally adjusted ventilatory assist. Curr Opin Crit Care. 2015 Feb;21(1):58-64. doi: 10.1097/MCC.0000000000000167.
Results Reference
background
PubMed Identifier
18629471
Citation
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.
Results Reference
background
PubMed Identifier
3324972
Citation
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.
Results Reference
background
PubMed Identifier
12470845
Citation
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.
Results Reference
background
PubMed Identifier
32388653
Citation
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.
Results Reference
derived

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Comparison Between NAVA and PSV in Neurocritical Patients

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