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Electrical Activity of the Diaphragm and Respiratory Mechanics During NAVA (NAVAMECH)

Primary Purpose

Work of Breathing, Lung Transplantation, Neurally Adjusted Ventilatory Assist

Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
NAVA GROUP
Sponsored by
University of Padova
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Work of Breathing focused on measuring Lung Injury, Ventilator-Induced Lung Injury, Neurally Adjusted Ventilatory Assist

Eligibility Criteria

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

Inclusion Criteria: Age > 18 y.o. Admission to ICU for post-operative monitoring after LTx Presence of spontaneous breathing activity Sedation titrated to a target RASS between 0 and -2 Written informed consent obtained Exclusion Criteria: Contraindication to nasogastric tube insertion (gastroesophageal surgery in the previous 3 months, gastroesophageal bleeding in the previous 30 days, history of esophageal varices, facial trauma) Increased risk of bleeding with nasogastric tube insertion, due to severe coagulation disorders and severe thrombocytopenia ( i.e., INR > 2 and platelets count < 70.000/mm3) Severe hemodynamic instability (noradenaline > 0.3 μg/kg/min and/or use of vasopressin) Postoperative extracorporeal respiratory support (ECMO) Pre-operative reconditioning of the transplanted lungs by means of ex-vivo lung perfusion (EVLP) Lung retransplantation Failure to obtain a stable EAdi signal

Sites / Locations

  • Institute of Anaesthesia and Intensive Care, Padua University hospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

NAVA group

Arm Description

Nava ventilation

Outcomes

Primary Outcome Measures

Electrical Activity of the Diaphragm (EAdi)
Evaluation of the variations of tidal volume Electrical Activity of the Diaphragm in response to different levels of ventilatory assist at different degrees of lung inflation (different Positive End Expiratory Pressure values). Electrical Activity of the Diaphragm (EAdi) (microVolt)
Neuro-Mechanical Coupling (NMC)
Evaluation of the variations of Neuro-Mechanical Coupling (expressed as microVolt of EAdi /cmH2O of airway pressure Ratio) in response to different levels of ventilatory assist at different degrees of lung inflation. Neuro-Mechanical Coupling (NMC) (microvolt/cmH2O)
Neuro-Ventilatory Efficiency (NVE)
Evaluation of the variations of Neuro-ventilatory Efficiency (expressed as microvolt of EAdi / mL of Tidal Volume Ratio) in response to different levels of ventilatory assist at different degree of lung inflation. Neuro-Ventilatory Efficiency (NVE) (microvolt/mL)
Respiratory rate (Breaths/min)
Evaluation of the changes in the patient's neural breathing pattern (expressed as mL of Tidal Volume) at different levels of ventilatory assist. Respiratory rate (Breaths/min)

Secondary Outcome Measures

Plateau Pressure (Pplat)
Evaluation of the feasibility of Plateau Pressure during NAVA.Plateau Pressure (Pplat)
Diaphragm's Thickening Fraction (TF)
Ultrasound assessment of the changes of Diaphragm's Thickening Fraction at different levels of Positive End Expiratory Pressure and at different NAVA gains
Total Asinchrony Index
Assesment of the total asynchrony index (double triggering + missed efforts + inspiratory trigger delay +short cycling + prolonged cycling)

Full Information

First Posted
January 9, 2023
Last Updated
January 23, 2023
Sponsor
University of Padova
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1. Study Identification

Unique Protocol Identification Number
NCT05689476
Brief Title
Electrical Activity of the Diaphragm and Respiratory Mechanics During NAVA
Acronym
NAVAMECH
Official Title
Evaluation of the Relationship Between Electrical Activity of the Diaphragm and Respiratory Mechanics During Neurally Adjusted Ventilatory Assist in Lung Transplant Patients.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 27, 2022 (Actual)
Primary Completion Date
December 27, 2024 (Anticipated)
Study Completion Date
December 27, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Padova

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Protective ventilatory strategy should be applied to reduce both ventilator-induced lung injury (VILI) and ventilator-induced diaphragm dysfunction (VIDD) after Lung Transplantation (LTx). Neurally Adjusted Ventilatory Assist (NAVA) is an assisted ventilation mode in which respiratory support is coordinated by the electrical activity of the diaphragm (EAdi). Aim of the study is to assess the physiological relationship between neural respiratory drive as assessed by EAdi and tidal volume, driving pressure and mechanical power, at different levels of ventilatory assist, in the absence of pulmonary vagal afferent feedback.
Detailed Description
Lung transplantation (LTx) is an important treatment option for select patients with end-stage pulmonary disease. In the early period following LTx a protective ventilatory strategy should be applied to reduce both ventilator-induced lung injury (VILI) and ventilator-induced diaphragm dysfunction (VIDD) after Lung Tranplantation (LTx). Neurally Adjusted Ventilatory Assist (NAVA) is an assisted ventilation mode in which neural inspiratory activity is monitored through the continuous recording of electrical activity of the diaphragm (EAdi) and then used to coordinate the respiratory support delivered by the ventilator. NAVA, because of its intrinsic properties (proportionality between respiratory drive and level of assist, prevention of diaphragm atrophy), could allow the aforementioned ventilatory strategy, however it may require the integrity of the pulmonary vagal afferent feedback in order to avoid volutrauma. So, the aim of the study is the evaluation of the physiological relationship between EAdi and tidal volume, driving pressure and mechanical power, at different levels of ventilatory assist, in the absence of pulmonary vagal afferent feedback, in early post-operative period after LTx.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Work of Breathing, Lung Transplantation, Neurally Adjusted Ventilatory Assist, Ventilator-Induced Lung Injury
Keywords
Lung Injury, Ventilator-Induced Lung Injury, Neurally Adjusted Ventilatory Assist

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Masking Description
none (open label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
NAVA group
Arm Type
Experimental
Arm Description
Nava ventilation
Intervention Type
Device
Intervention Name(s)
NAVA GROUP
Intervention Description
NAVA ventilation: Assisted Ventilation Mode, synchronized, through EAdi catheter, with patient's inspiratory effort and proportional to respiratory drive
Primary Outcome Measure Information:
Title
Electrical Activity of the Diaphragm (EAdi)
Description
Evaluation of the variations of tidal volume Electrical Activity of the Diaphragm in response to different levels of ventilatory assist at different degrees of lung inflation (different Positive End Expiratory Pressure values). Electrical Activity of the Diaphragm (EAdi) (microVolt)
Time Frame
One hour after the recovery of spontaneous breathing
Title
Neuro-Mechanical Coupling (NMC)
Description
Evaluation of the variations of Neuro-Mechanical Coupling (expressed as microVolt of EAdi /cmH2O of airway pressure Ratio) in response to different levels of ventilatory assist at different degrees of lung inflation. Neuro-Mechanical Coupling (NMC) (microvolt/cmH2O)
Time Frame
One hour after the recovery of spontaneous breathing
Title
Neuro-Ventilatory Efficiency (NVE)
Description
Evaluation of the variations of Neuro-ventilatory Efficiency (expressed as microvolt of EAdi / mL of Tidal Volume Ratio) in response to different levels of ventilatory assist at different degree of lung inflation. Neuro-Ventilatory Efficiency (NVE) (microvolt/mL)
Time Frame
One hour after the recovery of spontaneous breathing
Title
Respiratory rate (Breaths/min)
Description
Evaluation of the changes in the patient's neural breathing pattern (expressed as mL of Tidal Volume) at different levels of ventilatory assist. Respiratory rate (Breaths/min)
Time Frame
One hour after the recovery of spontaneous breathing
Secondary Outcome Measure Information:
Title
Plateau Pressure (Pplat)
Description
Evaluation of the feasibility of Plateau Pressure during NAVA.Plateau Pressure (Pplat)
Time Frame
One hour after the recovery of spontaneous breathing, with inspiratory hold manoeuvres
Title
Diaphragm's Thickening Fraction (TF)
Description
Ultrasound assessment of the changes of Diaphragm's Thickening Fraction at different levels of Positive End Expiratory Pressure and at different NAVA gains
Time Frame
One hour after the recovery of spontaneous breathing
Title
Total Asinchrony Index
Description
Assesment of the total asynchrony index (double triggering + missed efforts + inspiratory trigger delay +short cycling + prolonged cycling)
Time Frame
One hour after the recovery of spontaneous breathing

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age > 18 y.o. Admission to ICU for post-operative monitoring after LTx Presence of spontaneous breathing activity Sedation titrated to a target RASS between 0 and -2 Written informed consent obtained Exclusion Criteria: Contraindication to nasogastric tube insertion (gastroesophageal surgery in the previous 3 months, gastroesophageal bleeding in the previous 30 days, history of esophageal varices, facial trauma) Increased risk of bleeding with nasogastric tube insertion, due to severe coagulation disorders and severe thrombocytopenia ( i.e., INR > 2 and platelets count < 70.000/mm3) Severe hemodynamic instability (noradenaline > 0.3 μg/kg/min and/or use of vasopressin) Postoperative extracorporeal respiratory support (ECMO) Pre-operative reconditioning of the transplanted lungs by means of ex-vivo lung perfusion (EVLP) Lung retransplantation Failure to obtain a stable EAdi signal
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Annalisa Boscolo, MD
Phone
+390498213090
Email
annalisa.boscolobozza@aopd.veneto.it
First Name & Middle Initial & Last Name or Official Title & Degree
Nicolò Sella, MD
Phone
+390498213090
Email
nico.sella@hotmail.it
Facility Information:
Facility Name
Institute of Anaesthesia and Intensive Care, Padua University hospital
City
Padova
ZIP/Postal Code
35120
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Annalisa Boscolo, MD, PhD
Phone
+393498324972
Email
annalisa.boscolobozza@aopd.veneto.it

12. IPD Sharing Statement

Plan to Share IPD
No

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Electrical Activity of the Diaphragm and Respiratory Mechanics During NAVA

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