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

Sponsor

Policlinico Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT03367221

Collaborator

University of Lausanne Hospitals (Other)

Enrollment

Locations

Arm

23.3

Anticipated Duration (Months)

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Work of Breathing Lung Transplant; Complications Neurally Adjusted Ventilatory Assist Ventilator-Induced Lung Injury	Device: NAVA ventilation	N/A

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Physiological Response to Different Levels of Support in Lung Transplant Recipients Undergoing Neurally Adjusted Ventilatory Assist (NAVA)

Actual Study Start Date :

Nov 23, 2017

Anticipated Primary Completion Date :

Nov 1, 2019

Anticipated Study Completion Date :

Nov 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: NAVA group NAVA ventilation	Device: NAVA ventilation Assisted Ventilation Mode, synchronized, through EAdi catheter, with patient's inspiratory effort and proportional to respiratory drive

Arm

Intervention/Treatment

Experimental: NAVA group

NAVA ventilation

Device: NAVA ventilation

Assisted Ventilation Mode, synchronized, through EAdi catheter, with patient's inspiratory effort and proportional to respiratory drive

Outcome Measures

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) [One hour after the recovery of spontaneous breathing]
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 [One hour after the recovery of spontaneous breathing]
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 [One hour after the recovery of spontaneous breathing]
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 [One hour after the recovery of spontaneous breathing]
Tidal Volume (mL)
Evaluation of the changes in the patient's neural breathing pattern (expressed as respiratory rate) at different levels of ventilatory assist [One hour after the recovery of spontaneous breathing]
Respiratory rate (Breaths/min)

Secondary Outcome Measures

Evaluation of the feasibility of Plateau Pressure during NAVA [One hour after the recovery of spontaneous breathing, with inspiratory hold manoeuvres]
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 [One hour after the recovery of spontaneous breathing]
Diaphragm's Thickening Fraction (TF)
Assesment of the total asynchrony index (double triggering + missed efforts + inspiratory trigger delay +short cycling + prolonged cycling) [One hour after the recovery of spontaneous breathing]
Total Asinchrony Index

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ospedale Maggiore Policlinico	Milan		Italy	20122
2	University Hospital of Lausanne	Lausanne		Switzerland	10111

Sponsors and Collaborators

Policlinico Hospital
University of Lausanne Hospitals

Investigators

Principal Investigator: Chiara Abbruzzese, MD, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Principal Investigator: Luigi Castagna, MD, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Principal Investigator: Nicola Bottino, MD, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Principal Investigator: Alberto Zanella, MD, University of Milan
Principal Investigator: Nadia Corcione, MD, Fondazione IRCCS Ca' Granda
Principal Investigator: Antonio Pesenti, Prof, University of Milan

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Giacomo Grasselli, Prof, Policlinico Hospital

ClinicalTrials.gov Identifier:

NCT03367221

Other Study ID Numbers:

TRANS-NAVA

First Posted:

Dec 8, 2017

Last Update Posted:

Dec 8, 2017

Last Verified:

Dec 1, 2017

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Lung Injury

Ventilator-Induced Lung Injury

Study Results

No Results Posted as of Dec 8, 2017