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Physiological Response in Lung Transplant Recipients Undergoing Neurally Adjusted Ventilatory Assist (TRANS-NAVA)

Primary Purpose

Work of Breathing, Lung Transplant; Complications, Neurally Adjusted Ventilatory Assist

Status
Unknown status
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
NAVA ventilation
Sponsored by
Policlinico Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Work of Breathing

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

  • Ospedale Maggiore PoliclinicoRecruiting
  • University Hospital of LausanneRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

NAVA group

Arm Description

NAVA ventilation

Outcomes

Primary Outcome Measures

Evaluation of the variations of 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)
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)
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)
Evaluation of the changes in the patient's neural breathing pattern (expressed as mL of Tidal Volume) at different levels of ventilatory assist
Tidal Volume (mL)
Evaluation of the changes in the patient's neural breathing pattern (expressed as respiratory rate) at different levels of ventilatory assist
Respiratory rate (Breaths/min)

Secondary Outcome Measures

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

Full Information

First Posted
November 24, 2017
Last Updated
December 7, 2017
Sponsor
Policlinico Hospital
Collaborators
University of Lausanne Hospitals
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1. Study Identification

Unique Protocol Identification Number
NCT03367221
Brief Title
Physiological Response in Lung Transplant Recipients Undergoing Neurally Adjusted Ventilatory Assist
Acronym
TRANS-NAVA
Official Title
Physiological Response to Different Levels of Support in Lung Transplant Recipients Undergoing Neurally Adjusted Ventilatory Assist (NAVA)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Unknown status
Study Start Date
November 23, 2017 (Actual)
Primary Completion Date
November 2019 (Anticipated)
Study Completion Date
November 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Policlinico Hospital
Collaborators
University of Lausanne Hospitals

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
Primary Graft Dysfunction (PGD) respresents the leading cause of mortality in early post-operative period of Lung Tranplantation (LTx). Protective ventilatory strategy could potentially reduce the risk of PGD in these patients. Neurally Adjusted Ventilatory Assist (NAVA) is an assisted ventilation mode that could allow to adopt this strategy. Aim of the study is to assess the feasibility of NAVA in the early post-LTx phase and to describe the breathing pattern and the physiological relationship between neural respiratory drive and 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. Primary Graft Dysfunction (PGD) is the main cause of death; in the early period following LTx a protective ventilatory strategy (tidal volume - Vt of 6 mL/Kg + Positive End Expiratory Pressure) could potentially reduce the risk of PGD in these patients. 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). Actually, Guidelines about the adoption of a protective ventilatory strategy in the early post-opeartive period are lacking. NAVA, because of its intrinsic properties (proportionality between respiratory drive and level of assist, prevention of diaphragm atrophy), could allow to reach the afore mentioned ventilatory strategy. So, aim of the study, is the evaluation of patients' neural breathing pattern during NAVA, in early post-operative period of LTx

6. Conditions and Keywords

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

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
NAVA group
Arm Type
Experimental
Arm Description
NAVA ventilation
Intervention Type
Device
Intervention Name(s)
NAVA ventilation
Intervention Description
Assisted Ventilation Mode, synchronized, through EAdi catheter, with patient's inspiratory effort and proportional to respiratory drive
Primary Outcome Measure Information:
Title
Evaluation of the variations of 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)
Description
Electrical Activity of the Diaphragm (EAdi) (microVolt)
Time Frame
One hour after the recovery of spontaneous breathing
Title
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
Description
Neuro-Mechanical Coupling (NMC) (microvolt/cmH2O)
Time Frame
One hour after the recovery of spontaneous breathing
Title
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
Description
Neuro-Ventilatory Efficiency (NVE) (microvolt/mL)
Time Frame
One hour after the recovery of spontaneous breathing
Title
Evaluation of the changes in the patient's neural breathing pattern (expressed as mL of Tidal Volume) at different levels of ventilatory assist
Description
Tidal Volume (mL)
Time Frame
One hour after the recovery of spontaneous breathing
Title
Evaluation of the changes in the patient's neural breathing pattern (expressed as respiratory rate) at different levels of ventilatory assist
Description
Respiratory rate (Breaths/min)
Time Frame
One hour after the recovery of spontaneous breathing
Secondary Outcome Measure Information:
Title
Evaluation of the feasibility of Plateau Pressure during NAVA
Description
Plateau Pressure (Pplat)
Time Frame
One hour after the recovery of spontaneous breathing, with inspiratory hold manoeuvres
Title
Ultrasound assessment of the changes of Diaphragm's Thickening Fraction at different levels of Positive End Expiratory Pressure and at different NAVA gains
Description
Diaphragm's Thickening Fraction (TF)
Time Frame
One hour after the recovery of spontaneous breathing
Title
Assesment of the total asynchrony index (double triggering + missed efforts + inspiratory trigger delay +short cycling + prolonged cycling)
Description
Total Asinchrony Index
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
Giacomo Grasselli, Prof
Phone
0255033258
Email
giacomo.grasselli@unimi.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chiara Abbruzzese, MD
Organizational Affiliation
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Luigi Castagna, MD
Organizational Affiliation
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Nicola Bottino, MD
Organizational Affiliation
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Alberto Zanella, MD
Organizational Affiliation
University of Milan
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Nadia Corcione, MD
Organizational Affiliation
Fondazione IRCCS Ca' Granda
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Antonio Pesenti, Prof
Organizational Affiliation
University of Milan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ospedale Maggiore Policlinico
City
Milan
ZIP/Postal Code
20122
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Giacomo Grasselli, Prof
Phone
0255033258
Email
giacomo.grasselli@unimi.it
Facility Name
University Hospital of Lausanne
City
Lausanne
ZIP/Postal Code
10111
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lise Piquilloud, MD
Phone
+41 21 314 1632
Email
Lise.Piquilloud@chuv.ch

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
33892948
Citation
Grasselli G, Castagna L, Abbruzzese C, Corcione N, Bottino N, Guzzardella A, Colombo SM, Carlesso E, Mauri T, Rossetti V, Palleschi A, Scaravilli V, Zanella A, Pesenti A. Pulmonary volume-feedback and ventilatory pattern after bilateral lung transplantation using neurally adjusted ventilatory assist ventilation. Br J Anaesth. 2021 Jul;127(1):143-152. doi: 10.1016/j.bja.2021.03.010. Epub 2021 Apr 21.
Results Reference
derived

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Physiological Response in Lung Transplant Recipients Undergoing Neurally Adjusted Ventilatory Assist

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