Driving Pressure Variation: NAVA vs PSV

NCT03719365 | Unknown

• 1 other identifier: CE 110/18
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Assisted ventilation represents, nowadays, the preferred ventilation mode in clinical practice.It has been shown that assisted ventilation modes improve ventilation/perfusion matching, descrease risk of Ventilator induced lung injury and muscle atrophy and have less influence on haemodynamic function. However, PSV (Pressure Support Ventilation) is not free from complications: it may worsen or cause lung injuries by increasing alveolar and intrathoracic negative pressure and by loosing control on Tidal Volume (Vt). Indeed, it has been demonstrated that Vt is the main factor related to VILI. It has been shown that lower Vt and higher PEEP can improve clinical outcome only if associated with a simultaneous reduction in Driving Pressure. Increase in Driving Pressure resulted strongly associated with negative outcomes, especially if higher than 15 cm H2O. PSV is currently the most used assisted ventilation mode. NAVA (Neurally Adjusted Ventilatory Assist) is a ventilation mode in which the diaphragmatic electrical activity (EAdi) is used as a trigger to start a mechanical breath, applying positive pressure during patient's inspiration. Diaphragmatic electrical activity (EAdi) can be detected by a particular nasogastric tube (EAdi catheter). EAdi is the currently available signal closest to the neural breathing centers, which can estimate the patient's respiratory drive, if phrenic nerves are not damaged. It has been demonstrated that NAVA ventilation can reduce the incidence of patient-ventilator asynchronies, because the delivery of the support and the cycling between inspiration and expiration are completely controlled by the patient. However, although PSV and NAVA have been widely compared in many investigations, up to now there are no studies about driving pressure variation during these two modalities of mechanical assisted ventilation. The aim of this study is to measure changes in driving pressure at different levels of ventilatory assistance in PSV and NAVA ventilation modes. Secondary end points are respiratory mechanics indices and patient/ventilator related asynchrony evaluation and comparison.

Conditions

Mechanical Ventilation Complication; Ventilator-Induced Lung Injury

Keywords

PSV; NAVA; Driving Pressure; Mechanical Assisted Ventilation

Outcome Measures

Primary Outcomes (1)

• Driving pressure in PSV and NAVA

  Driving Pressure measurements in in PSV and NAVA (cmH2O)

  At the end of every 20 minutes lasting ventilation trial.

Secondary Outcomes (4)

• Respiratory mechanical indices variation

  At the end of every 20 minutes lasting ventilation trial.

• Patient/ventilator interaction

  At the end of every 20 minutes lasting ventilation trial.

• Patient/ventilator interaction

  At the end of every 20 minutes lasting ventilation trial.

• diaphragm ultrasound

  At the end of every 20 minutes lasting ventilation trial.

Study Arms (1)

NAVAPSV

EXPERIMENTAL

Each patient enrolled in the study will be submitted to 3 ventilation trials during PSV and NAVA ventilation modes, assigned in a randomized order.

Device: NAVAPSV

Interventions

NAVAPSV DEVICE

During the first trial, PSV will be set in order to obtain a Vt between 6 and 8 ml/kg; this support level will be defined as PSV100. Subsequently, the corresponding NAVA level (NAVA 100) will be determined using a dedicated ventilator function (NAVA Preview) which is able to estimate NAVA level in order to deliver an equivalent inspiratory peak pressure (Paw peak) compared to that obtained during PSV mode. Afterwards, PSV100 and NAVA100 will be first increased (PSV150 and NAVA150) during the second trial and then decreased during the third trial (PSV50 and NAVA150) by 50% from basal value. During the study period, PEEP and FiO2 will be kept equal to the values in use before patient enrollment.

NAVAPSV

Eligibility Criteria

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

You may qualify if:

• Age \>18 years
• Every patients undergoing partial assisted mechanical ventilation

You may not qualify if:

• Gastro-esophageal surgery in the previous 12 months;
• Gastro-esophageal bleeding in the previous 30 days;
• Esophageal varices history;
• Maxillo-facial surgery or trauma;
• Haemodinamic instability despite adequate fluid infusion (i.e. need for continuous infusion epinephrine or vasopressin or dopamine at a dose greater than 5 mcg/kg/min to obtain systolic pressure \> 90 mmHg);
• Body temperature \> 38° C during the study screening;
• Coagulation disorders (INR \> 1.5, aPTT \> 44 sec);
• Vt \< 8 ml/kg with minimum inspiratory effort of 8 cmH2O;

Sponsors & Collaborators

• Azienda Ospedaliero Universitaria Maggiore della Carita: lead

Study Sites (1)

A.O.U Maggiore della Carità

Novara, 28100, Italy

RECRUITING

Related Publications (24)

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  PMID: 33559864 DERIVED

MeSH Terms

Conditions

Ventilator-Induced Lung Injury

Condition Hierarchy (Ancestors)

Lung Injury; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Gianmaria Cammarota, MD, PhD

  AOU Maggiore della Carità

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gianmaria Cammarota, MD, PhD

CONTACT

00393392669420; gmcamma@gmail.com

Study Design

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

Model Details: Randomized, interventional, prospective study

Study Record Dates

• First Submitted: October 19, 2018
• First Posted: October 25, 2018
• Study Start: November 1, 2018
• Primary Completion: December 1, 2019
• Study Completion: November 1, 2020
• Last Updated: April 12, 2019

Record last verified: 2019-04

Locations

IT (1)