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Completed

NCT Number: NCT03962322

Diaphragmatic Tissue Doppler During Weaning From Mechanical Ventilation

Weaning from mechanical ventilation is a critical issue and the diaphragmatic disfunction has been demonstrated to play an important role in extubation failure. the aim of present investigation is to evaluate diaphragmatic excursion velocity during in patients undergoing spontaneous breathing trial through tissue Doppler analysis in both inspiration and expiration.

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Key information

Conditions

Weaning From Mechanical Ventilation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

A.O.U Maggiore della Carità

Novara, 28100, Italy

About this study

Tobin Index (RSBI), which is the ratio between respiratory rate (RR) and tidal volume (VT), is one of the most used indices to predict weaning outcome. The diaphragm plays a key role in generating VT and, in the case of diaphragmatic dysfunction, inspiratory accessory muscles may contribute to support ventilation. If this occurs during a spontaneous breathing trial (SBT), it will probably result in delayed weaning, since the accessory muscles are more fatigable than the diaphragm.

The diaphragmatic tissue Doppler imaging (TDI) is an ultrasonographic technique derived from ultrasound evaluation of heart's motility. Being a muscle doppler assessment, it can be easily used on the diaphragm to calculate the speed of muscles displacement that could be associated with patient's respiratory drive, as well as other derived index of muscle function.

The aim of the study is to measure the variations of diaphragmatic displacement velocities before and during the spontaneous breathing trial, useful to check if the patient is ready to breathe spontaneously. An observational study will be performed. Patients who are ready to be weaned will be subjected to a spontaneous breathing test (Cpap 5), that consists of applying a positive end-expiratory pressure of 5 cm H2O for 20 minutes. A tissue Doppler evaluation will then be performed by analyzing the diaphragmatic displacement velocity during inspiration and expiration in the modality of ventilation which precedes the trial and during the SBT.

Vital parameters will be monitored during the study. Mechanical ventilation length, incidence of tracheostomies, ICU and hospital recovery duration and hospital mortality will also be acquired.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • mechanical invasive ventilation ≥ 24 h
  • readiness for extubation

Exclusion criteria

  • refusal to grant consent
  • pregnancy
  • hemodynamic instability
  • difficult management of secretions
  • request for inotropy and/or vasoactive drugs at high doses

Treatment and study plan

Weaning TDI

Other

Patients will be subjected to a spontaneous breathing test (Cpap 5), that consists in applying a positive end-expiratory pressure of 5 cm H2O for 20 minutes.

A tissue doppler evaluation will then be performed by analyzing the diaphragmatic displacement velocity during inspiration and expiration and calculating the speed of muscles displacement and other derived index of muscle function in the modality of ventilation which precedes the trial, during the SBT and after extubation.

Primary outcomes

  1. Primary Outcome Measure - Change in diaphragmatic displacement velocity

    Time frame: through each trial completion, an average of 20 minutes

    Inspiratory and expiratory diaphragmatic displacement velocity evaluated with tissue doppler during the assisted ventilation modality which preceded the trial, during the spontaneous breathing trial ( CPAP 5 ) and in spontaneous breathing.

Secondary outcomes

  1. Diaphragmatic acceleration and deceleration

    Time frame: through each trial completion, an average of 20 minutes

    Diaphragmatic acceleration and deceleration evaluated with tissue doppler during the assisted ventilation modality which preceded the trial, during the spontaneous breathing trial ( CPAP 5 ) and in spontaneous breathing.

  2. Gas exchange - arterial carbon dioxide tension

    Time frame: through each trial completion, an average of 20 minutes

    Arterial blood gases sample

  3. Gas exchange - pH

    Time frame: through each trial completion, an average of 20 minutes

    Arterial blood gases sample

  4. Gas exchange - arterial oxygen tension

    Time frame: through each trial completion, an average of 20 min

    Arterial blood gases sample

  5. Dyspnea level

    Time frame: through each trial completion, an average of 20 minutes

    Dyspnea level will be evaluated through visual analogical scale ( VAS dyspnea). The dyspnea visual analog scale is represented by a 20 cm horizontal line. The ends are defined as the extreme limits of dyspnea from the left-lower end best, "not at all breathless"-to the right-upper end worst, "extremely breathless". Subjects will be instructed to indicate on the line the point corresponding to their breathlessness perception.

  6. Heart rate

    Time frame: through each trial completion, an average of 20 minutes

    Heart Rate (HR) averages during each of the 3 ventilatory modes

  7. Number of patients who experienced weaning failure

    Time frame: over 48 hours following extubation

    the need for non invasive ventilation or re-intubation due to any cause

  8. Blood Pressure

    Time frame: through each trial completion, an average of 20 minutes

    Mean arterial Blood Pressure (BP) averages during each of the 3 ventilatory modes

Sponsors and collaborators

Lead sponsor

Azienda Ospedaliero Universitaria Maggiore della Carita

Other

Registry information

Acronym: TDD-wean

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
May 24, 2019
Registry last updated
Apr 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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