Tissue Doppler Ultrasound During Spontaneous Breathing and Non-invasive Ventilation in the Post-extubation Period.

NCT ID: NCT03978221

Last Updated: 2019-07-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-01

Study Completion Date

2020-04-01

Brief Summary

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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.

Detailed Description

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Early weaning from invasive ventilation, in patients admitted to intensive care, is associated with a marked reduction in ventilator-associated pneumonia, length of stay in intensive care unit and hospital, total duration of mechanical ventilation and decrease in overall mortality. Moreover, in case of need of protected extubation, non-invasive ventilation has allowed to prevent re-intubation and decrease hospital mortality compared to the simple administration of oxygen through a facial mask, in particular when applied immediately after extubation.

The diaphragmatic tissue doppler imaging (TDI) is an ultrasonographic technique derived from ultrasound evaluation of the heart's motility. It can be easily used on the diaphragm to calculate the speed of muscles displacement that could be associated with patient's respiratory drive.

The aim of the study is the evaluation of the diaphragmatic excursion velocity variations using diaphragmatic tissue doppler, measured in venturi mask and non-invasive ventilation in the post-extubation period, in order to compare the diaphragm stress variations during the two different modes.

Method Patients after extubation will be randomly submitted to a spontaneous breathing test in venturi mask and in facemask or helmet NIV.

Each trial will last 20 minutes. During the last minute of each trial a tissue doppler diaphragm examination will be performed to assess the speed speed of muscle displacement, acceleration and deceleration.

Inclusion criteria: invasive mechanical ventilation \> 24h with consequent extubation.

Exclusion criteria: refusal to grant consent, pregnancy, age \< 18 years, haemodynamic instability, difficult management of secretions, required inotropic and / or vasoactive drugs at high doses.

During the study, vital parameters will be given.

Conditions

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Acute Respiratory Failure Non-invasive Ventilation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Single Group Assignment
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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diaphragmatic tissue doppler evaluation

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

Group Type EXPERIMENTAL

Post-extubation TDI

Intervention Type OTHER

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.

Interventions

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Post-extubation TDI

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* invasive mechanical ventilation \> 24h with consequent extubation

Exclusion Criteria

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

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Azienda Ospedaliero Universitaria Maggiore della Carita

OTHER

Sponsor Role lead

Responsible Party

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Gianmaria Cammarota

Principal Investigator, MD of ICU staff

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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A.O.U Maggiore della Carità

Novara, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Gianmaria Cammarota, MD,PHD

Role: CONTACT

00393392669420

Gianmaria MD Cammarota

Role: CONTACT

00393392669420

Facility Contacts

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Gianmaria Cammarota, MD, PHD

Role: primary

+393213733406

References

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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.

Reference Type BACKGROUND
PMID: 30535516 (View on PubMed)

Other Identifiers

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CE 22/19

Identifier Type: -

Identifier Source: org_study_id

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