NCT03978221

Brief Summary

The aim of the present investigation will be to evaluate diaphragmatic excursion velocity during non-invasive ventilation and spontaneous breathing at both inspiration and expiration. this analysis will be performed through diaphragmatic tissue Doppler assessment.

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
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 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

Study Start

First participant enrolled

April 1, 2019

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 13, 2019

Completed
25 days until next milestone

First Posted

Study publicly available on registry

June 7, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 12, 2019

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2020

Completed
Last Updated

July 23, 2019

Status Verified

May 1, 2019

Enrollment Period

9 months

First QC Date

May 13, 2019

Last Update Submit

July 21, 2019

Conditions

Acute Respiratory FailureNon-invasive Ventilation

Keywords

Diaphragmatic Tissue DopplerNon invasive ventilationSpontaneous breathingPost-extubation

Outcome Measures

Primary Outcomes (1)

  • diaphragmatic displacement velocity

    Inspiratory and expiratory diaphragmatic displacement velocity evaluated with tissue doppler during the NIV trial and in spontaneous breathing with Venturi mask.

    through each trial completion, an average of 20 minutes

Secondary Outcomes (8)

  • Diaphragmatic acceleration

    through each trial completion, an average of 20 minutes

  • Gas exchange - arterial carbon dioxide tension

    through each trial completion, an average of 20 minutes

  • Gas exchange - pH

    through each trial completion, an average of 20 minutes

  • Gas exchange - arterial oxygen tension

    through each trial completion, an average of 20 minutes

  • Dyspnea level

    through each trial completion, an average of 20 minutes

  • +3 more secondary outcomes

Study Arms (1)

diaphragmatic tissue doppler evaluation

EXPERIMENTAL

A tissue Doppler evaluation, using a sectorial probe, will be performed by analyzing the diaphragmatic displacement velocity during inspiration and expiration randomly assessed in spontaneous breathing with Venturi Mask and in Non-invasive ventilation with a helmet or facial mask

Other: Post-extubation TDI

Interventions

Post-extubation TDIOTHER

A diaphragmatic tissue Doppler evaluation will be performed during non-invasive ventilation and spontaneous breathing trial applied in random sequence. Each trial will last 20 minutes. During the last minute of each trial a tissue doppler diaphragmatic examination will be performed to assess the speed of diaphragmatic displacement during inspiration and expiration.

diaphragmatic tissue doppler evaluation

Eligibility Criteria

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

You may qualify if:

  • invasive mechanical ventilation \> 24h with consequent extubation

You may not qualify if:

  • refusal to grant consent
  • pregnancy
  • age \>18 years
  • haemodynamic instability
  • difficult management of secretions
  • required inotropic and / or vasoactive drugs at high doses

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

A.O.U Maggiore della Carità

Novara, 28100, Italy

RECRUITING

Related Publications (1)

  • Vaschetto R, Longhini F, Persona P, Ori C, Stefani G, Liu S, Yi Y, Lu W, Yu T, Luo X, Tang R, Li M, Li J, Cammarota G, Bruni A, Garofalo E, Jin Z, Yan J, Zheng R, Yin J, Guido S, Della Corte F, Fontana T, Gregoretti C, Cortegiani A, Giarratano A, Montagnini C, Cavuto S, Qiu H, Navalesi P. Early extubation followed by immediate noninvasive ventilation vs. standard extubation in hypoxemic patients: a randomized clinical trial. Intensive Care Med. 2019 Jan;45(1):62-71. doi: 10.1007/s00134-018-5478-0. Epub 2018 Dec 10.

    PMID: 30535516BACKGROUND

Central Study Contacts

Gianmaria Cammarota, MD,PHD

CONTACT

00393392669420gmcamma@gmail.com

Gianmaria MD Cammarota

CONTACT

00393392669420

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Single Group Assignment
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, MD of ICU staff

Study Record Dates

First Submitted

May 13, 2019

First Posted

June 7, 2019

Study Start

April 1, 2019

Primary Completion

December 12, 2019

Study Completion

April 1, 2020

Last Updated

July 23, 2019

Record last verified: 2019-05

Locations

IT(1)