NCT03941002

Brief Summary

Aim of mechanical ventilation is to improve gas exchange and to unload the respiratory muscles delivering a form of mechanical support to the ventilation. At the same time, it is essential that the support is individually-tailored to avoid the development of muscular atrophy, a process called "ventilatory-induced diaphragm dysfunction" Aim of the present study is that the continuous ultrasonographic assesment of diaphragm function, as obtained by the device under investigation (DiaMon, Respinor AS, Oslo, Norway) is related to the degree of effort of inspiratory muscles, as measured by gold-standard indices such as esophageal and gastric pressure measurement. A secondary aim is that the data assessed by the device are related to a standard ultrasonographic examination performed by expert operators. In particular, we will enroll a population of critically ill patients undergoing mechanical ventilation in assisted mode, and we will perform a decremental pressure support trial, with the following aims:

  1. 1.to evaluate the performance of a continuous and automated device for the monitoring of diaphragm contractile activity, as compared to standard mechanical indices of respiratory effort such as the pressure-time product (PTP)
  2. 2.to evaluate the performance of a continuous and automated device for the monitoring of diaphragm contractile activity, as compared to the ultrasonographic assesment of muscle function performed by an expert operator.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2019

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 3, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 7, 2019

Completed
5 months until next milestone

Study Start

First participant enrolled

September 30, 2019

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
Last Updated

November 5, 2020

Status Verified

November 1, 2020

Enrollment Period

1.8 years

First QC Date

May 3, 2019

Last Update Submit

November 3, 2020

Conditions

Respiration, ArtificialMechanical VentilationCritical Illness

Outcome Measures

Primary Outcomes (1)

  • Diaprhagm excursion

    Excursion (in mm) between expiration and inspiration

    Study 1 day

Secondary Outcomes (3)

  • Esophageal pressure swing

    Study 1 day

  • Pressure-time product

    Study 1 day

  • Pressure-time product

    Study 1 day

Study Arms (3)

Clinical pressure support

PLACEBO COMPARATOR

The level of inspiratory pressure support will be selected by the attending physician

Diagnostic Test: Assesment of diaphragm function

Reduced pressure support

ACTIVE COMPARATOR

The level of inspiratory pressure support will be reduced by 25%

Diagnostic Test: Assesment of diaphragm function

Lowest pressure support

ACTIVE COMPARATOR

The level of inspiratory pressure support will be reduced by 50%

Diagnostic Test: Assesment of diaphragm function

Interventions

Assesment of diaphragm functionDIAGNOSTIC_TEST

Diaphragm function will be assessed by standard mechanical parameters as assessed by esophageal and gastric pressure measurement, as well as by an ultrasonographic examination performed by an expert operator and by the continuous ultrasonographic assessment provided by the device under investigation

Clinical pressure supportLowest pressure supportReduced pressure support

Eligibility Criteria

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

You may qualify if:

  • Acute respiratory failure which necessitated endotracheal intubation and mechanical ventilation, with ventilation in pressure-support mode.
  • Positive end-expiratory pressure (PEEP) lower than 10 cmH2O
  • Pressure support level between 4 and 10 cmH2O
  • Ratio between PaO2 and FiO2 \>200 mmHg
  • Resolution of the cause of respiratory failure

You may not qualify if:

  • Diagnosis of Chronic Obstructive Pulmonary Disease (COPD)
  • Pregnancy
  • Circulatory failure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ospedale San Paolo - Polo Universitario, ASST Santi Paolo e Carlo

Milan, MI, 20142, Italy

RECRUITING

MeSH Terms

Conditions

Respiratory AspirationCritical Illness

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsDisease Attributes

Central Study Contacts

Davide Chiumello

CONTACT

+390281844476davide.chiumello@unimi.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Intensive Care

Study Record Dates

First Submitted

May 3, 2019

First Posted

May 7, 2019

Study Start

September 30, 2019

Primary Completion

June 30, 2021

Study Completion

June 30, 2021

Last Updated

November 5, 2020

Record last verified: 2020-11

Locations

IT(1)