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

Evaluation of the Relationship Between Electrical Activity of the Diaphragm and Respiratory Mechanics During Neurally Adjusted Ventilatory Assist in Lung Transplant Patients.

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.

Study Overview

• Status: Recruiting
• Conditions: Ventilator-Induced Lung Injury; Lung Transplantation; Work of Breathing; Neurally Adjusted Ventilatory Assist
• Intervention / Treatment: Device: NAVA GROUP

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.

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Annalisa Boscolo, MD; Phone Number: +390498213090; Email: annalisa.boscolobozza@aopd.veneto.it
• Study Contact Backup: Name: Nicolò Sella, MD; Phone Number: +390498213090; Email: nico.sella@hotmail.it

Study Locations

• Italy
  • Padova, Italy, 35120
    • Recruiting
    • Institute of Anaesthesia and Intensive Care, Padua University hospital
    • Contact: Annalisa Boscolo, MD, PhD; Phone Number: +393498324972; Email: annalisa.boscolobozza@aopd.veneto.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	One hour after the recovery of spontaneous breathing
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)	One hour after the recovery of spontaneous breathing
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)	One hour after the recovery of spontaneous breathing
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)	One hour after the recovery of spontaneous breathing

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plateau Pressure (Pplat)	Evaluation of the feasibility of Plateau Pressure during NAVA.Plateau Pressure (Pplat)	One hour after the recovery of spontaneous breathing, with inspiratory hold manoeuvres
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	One hour after the recovery of spontaneous breathing
Total Asinchrony Index	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

Collaborators and Investigators

• Sponsor: University of Padova

Study record dates

Study Major Dates

• Study Start (Actual): December 27, 2022
• Primary Completion (Anticipated): December 27, 2024
• Study Completion (Anticipated): December 27, 2024

Study Registration Dates

• First Submitted: January 9, 2023
• First Submitted That Met QC Criteria: January 9, 2023
• First Posted (Actual): January 19, 2023

Study Record Updates

• Last Update Posted (Estimate): January 26, 2023
• Last Update Submitted That Met QC Criteria: January 23, 2023
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: Ventilator-Induced Lung Injury; Neurally Adjusted Ventilatory Assist; Lung Injury
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Wounds and Injuries; Thoracic Injuries; Lung Injury; Ventilator-Induced Lung Injury
• Other Study ID Numbers: NAVAMECH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No