Diaphragmatic Tissue Doppler During Weaning From Mechanical Ventilation

NCT03962322 | Completed

• 1 other identifier: CE 23/19
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Weaning From Mechanical Ventilation

Keywords

Diaphragmatic Tissue Doppler; Weaning; Mechanical ventilation

Outcome Measures

Primary Outcomes (1)

• Primary Outcome Measure - Change in diaphragmatic displacement velocity

  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.

  through each trial completion, an average of 20 minutes

Secondary Outcomes (8)

• Diaphragmatic acceleration and deceleration

  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 min

• Dyspnea level

  through each trial completion, an average of 20 minutes

Study Arms (1)

Weaning TDI

EXPERIMENTAL

A tissue doppler evaluation, using a sector transducer, will be performed by analyzing the diaphragmatic displacement velocity during inspiration and expiration in the modality of ventilation which precedes the trial, during the SBT and after extubation.

Other: Weaning TDI

Interventions

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.

Weaning TDI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• mechanical invasive ventilation ≥ 24 h
• readiness for extubation

You may not qualify if:

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

Sponsors & Collaborators

• Azienda Ospedaliero Universitaria Maggiore della Carita: lead

Study Sites (1)

A.O.U Maggiore della Carità

Novara, 28100, Italy

Location

Related Publications (2)

• Tobin MJ. Respiratory monitoring in the intensive care unit. Am Rev Respir Dis. 1988 Dec;138(6):1625-42. doi: 10.1164/ajrccm/138.6.1625.

  PMID: 3144222 BACKGROUND

• Cammarota G, Boniolo E, Santangelo E, De Vita N, Verdina F, Crudo S, Sguazzotti I, Perucca R, Messina A, Zanoni M, Azzolina D, Navalesi P, Longhini F, Vetrugno L, Bignami E, Della Corte F, Tarquini R, De Robertis E, Vaschetto R. Diaphragmatic Kinetics Assessment by Tissue Doppler Imaging and Extubation Outcome. Respir Care. 2021 Jun;66(6):983-993. doi: 10.4187/respcare.08702. Epub 2021 Apr 27.

  PMID: 33906957 DERIVED

Study Design

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

Model Details: Single Group Assignment

Study Record Dates

• First Submitted: May 13, 2019
• First Posted: May 24, 2019
• Study Start: May 27, 2019
• Primary Completion: November 29, 2019
• Study Completion: November 29, 2019
• Last Updated: April 28, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)