Physiological Response in Lung Transplant Recipients Undergoing Neurally Adjusted Ventilatory Assist

NCT03367221 | Unknown

• 1 other identifier: TRANS-NAVA
• Study Type: interventional
• Target: 20
• Locations: 2 countries
• Sites: 2

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.

Conditions

Work of Breathing; Lung Transplant; Complications; Neurally Adjusted Ventilatory Assist; Ventilator-Induced Lung Injury

Outcome Measures

Primary Outcomes (5)

• 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)

  One hour after the recovery of spontaneous breathing

• 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)

  One hour after the recovery of spontaneous breathing

• 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)

  One hour after the recovery of spontaneous breathing

• 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)

  One hour after the recovery of spontaneous breathing

• 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)

  One hour after the recovery of spontaneous breathing

Secondary Outcomes (3)

• Evaluation of the feasibility of Plateau Pressure during NAVA

  One hour after the recovery of spontaneous breathing, with inspiratory hold manoeuvres

• 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

• 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

Study Arms (1)

NAVA group

EXPERIMENTAL

NAVA ventilation

Device: NAVA ventilation

Interventions

NAVA ventilation DEVICE

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

NAVA group

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Policlinico Hospital: lead
• University of Lausanne Hospitals: collaborator

Study Sites (2)

Ospedale Maggiore Policlinico

Milan, 20122, Italy

RECRUITING

University Hospital of Lausanne

Lausanne, 10111, Switzerland

RECRUITING

Related Publications (1)

• 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.

  PMID: 33892948 DERIVED

MeSH Terms

Conditions

Ventilator-Induced Lung Injury

Condition Hierarchy (Ancestors)

Lung Injury; Lung Diseases; Respiratory Tract Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Giacomo Grasselli, Prof

CONTACT

0255033258; giacomo.grasselli@unimi.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof

Study Record Dates

• First Submitted: November 24, 2017
• First Posted: December 8, 2017
• Study Start: November 23, 2017
• Primary Completion: November 1, 2019
• Study Completion: November 1, 2019
• Last Updated: December 8, 2017

Record last verified: 2017-12

Locations

CH (1); IT (1)