Diaphragmatic Ultrasound Associated With RSBI Predict Weaning Issue: the Rapid Shallow Diaphragmatic Index (RSDI)

NCT ID: NCT03479047

Last Updated: 2019-05-06

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

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-23

Study Completion Date

2019-01-16

Brief Summary

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The Rapid Shallow Breathing Index (RSBI) is the ratio between respiratory rate (RR) and tidal volume (VT). It is routinely used to predict mechanical ventilation weaning outcome in ICU patients. However RSBI doesn't reflect the muscular contribution of diaphragm or accessory muscles in generating tidal volume. Actually, diaphragmatic dysfunction can even delay weaning process, because accessory muscles are more fatigable than the diaphragm.

Hence, the investigators hypothesized that diaphragmatic displacement (DD) could be associated with RSBI in a new index named Rapid Shallow Diaphragmatic Index (RSDI) such as: RSDI = RSBI/DD.

The aim of this study is to compare the ability of the RSDI versus the traditional RSBI to predict weaning success in ready-to-wean patients.

Detailed Description

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Conditions

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Mechanical Ventilation Mechanical Ventilator Weaning Extubation Diaphragm Ultrasound

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Ventilated patients

During a spontaneous breathing trial (SBT) we will simultaneously, for all included patient, assess diaphragmatic displacement (DD) using ultrasonography, respiratory rate (RR) and tidal volume (VT) on ventilator screen.

Group Type EXPERIMENTAL

assess diaphragmatic displacement (DD) using ultrasonography

Intervention Type DIAGNOSTIC_TEST

During a spontaneous breathing trial (SBT) we will simultaneously, for all included patient, assess diaphragmatic displacement (DD) using ultrasonography, respiratory rate (RR) and tidal volume (VT) on ventilator screen.

Interventions

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assess diaphragmatic displacement (DD) using ultrasonography

During a spontaneous breathing trial (SBT) we will simultaneously, for all included patient, assess diaphragmatic displacement (DD) using ultrasonography, respiratory rate (RR) and tidal volume (VT) on ventilator screen.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Age ≥ 18 years
* Mechanically ventilated patient \> 24 hours
* Weaning ventilator phase (PEEP \< 9 cmH2O and Support \< 15 cm H2O)
* Ventilated via tracheostomy tube patient can be included on removal day of the cannula
* Patient's agreement to participate

Exclusion Criteria

* Moribund patient
* Decision to forgo life sustaining therapy patient
* Patient with ventilation via tracheostomy tube before admission to ICU
* BMI \> 45
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Régional d'Orléans

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Guillaume FOSSAT

Role: PRINCIPAL_INVESTIGATOR

CHR Orléans

Locations

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CHR d'Orléans

Orléans, , France

Site Status

Countries

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France

References

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Spadaro S, Grasso S, Mauri T, Dalla Corte F, Alvisi V, Ragazzi R, Cricca V, Biondi G, Di Mussi R, Marangoni E, Volta CA. Can diaphragmatic ultrasonography performed during the T-tube trial predict weaning failure? The role of diaphragmatic rapid shallow breathing index. Crit Care. 2016 Sep 28;20(1):305. doi: 10.1186/s13054-016-1479-y.

Reference Type BACKGROUND
PMID: 27677861 (View on PubMed)

DiNino E, Gartman EJ, Sethi JM, McCool FD. Diaphragm ultrasound as a predictor of successful extubation from mechanical ventilation. Thorax. 2014 May;69(5):423-7. doi: 10.1136/thoraxjnl-2013-204111. Epub 2013 Dec 23.

Reference Type BACKGROUND
PMID: 24365607 (View on PubMed)

Farghaly S, Hasan AA. Diaphragm ultrasound as a new method to predict extubation outcome in mechanically ventilated patients. Aust Crit Care. 2017 Jan;30(1):37-43. doi: 10.1016/j.aucc.2016.03.004. Epub 2016 Apr 22.

Reference Type BACKGROUND
PMID: 27112953 (View on PubMed)

Boussuges A, Gole Y, Blanc P. Diaphragmatic motion studied by m-mode ultrasonography: methods, reproducibility, and normal values. Chest. 2009 Feb;135(2):391-400. doi: 10.1378/chest.08-1541. Epub 2008 Nov 18.

Reference Type BACKGROUND
PMID: 19017880 (View on PubMed)

Forgiarini LA Junior, Esquinas AM. The rapid shallow breathing index as a predictor of successful mechanical ventilation weaning: clinical utility when calculated from ventilator data. J Bras Pneumol. 2016 Jul-Aug;42(4):306. doi: 10.1590/S1806-37562016000000099. No abstract available.

Reference Type BACKGROUND
PMID: 27832242 (View on PubMed)

Other Identifiers

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CHRO-2018-02

Identifier Type: -

Identifier Source: org_study_id

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