NCT05689476

Brief Summary

Protective ventilatory strategy should be applied to reduce ventilator-induced lung injury (VILI) after Lung Transplantation (LTx) or in case of acute respiratory failure requiring invasive mechanical ventilation. 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 or during acute respiratory failure. Additional parameters will be collected: Pmus, Pocc, transpulmonary pressure etc.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 27, 2022

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

January 9, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 19, 2023

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 27, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 27, 2025

Completed
Last Updated

July 8, 2025

Status Verified

January 1, 2025

Enrollment Period

3 years

First QC Date

January 9, 2023

Last Update Submit

July 1, 2025

Conditions

Work of BreathingLung TransplantationNeurally Adjusted Ventilatory AssistVentilator-Induced Lung InjuryAcute Respiratory Failure (ARF)

Keywords

Lung InjuryVentilator-Induced Lung InjuryNeurally Adjusted Ventilatory Assist

Outcome Measures

Primary Outcomes (2)

  • 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

  • Tidal Volume (mL) and 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. Also patient's respiratory rate (Breaths/min) will be evaluated

    One hour after the recovery of spontaneous breathing

Secondary Outcomes (2)

  • Driving pressure (DP)

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

  • Occlusion Pression (Pocc)

    One hour after the recovery of spontaneous breathing

Other Outcomes (1)

  • PaO2/FiO2 ratio

    One hour after the recovery of spontaneous breathing

Study Arms (1)

NAVA group

EXPERIMENTAL

Nava ventilation

Device: NAVA GROUP

Interventions

NAVA GROUPDEVICE

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

NAVA group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \> 18 y.o.
  • Admission to ICU for post-operative monitoring after LTx or acute respiratory failure needing invasive mechanical ventilation
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Anaesthesia and Intensive Care, Padua University hospital

Padua, Italy, 35120, Italy

RECRUITING

MeSH Terms

Conditions

Ventilator-Induced Lung InjuryLung Injury

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesThoracic InjuriesWounds and Injuries

Central Study Contacts

Annalisa Boscolo, MD

CONTACT

+390498213090annalisa.boscolobozza@aopd.veneto.it

Nicolò Sella, MD

CONTACT

+390498213090nico.sella@hotmail.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
none (open label)
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 9, 2023

First Posted

January 19, 2023

Study Start

December 27, 2022

Primary Completion

December 27, 2025

Study Completion

December 27, 2025

Last Updated

July 8, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)