Diaphragmatic Tissue Doppler During Weaning From Mechanical Ventilation

NCT ID: NCT03962322

Last Updated: 2020-04-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-27
• Study Completion Date: 2019-11-29

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.

Detailed Description

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.

Conditions

Weaning From Mechanical Ventilation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Weaning TDI

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.

Group Type: EXPERIMENTAL

Weaning TDI

Intervention Type: 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.

Interventions

Weaning TDI

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Azienda Ospedaliero Universitaria Maggiore della Carita

OTHER

Sponsor Role: lead

Responsible Party

Gianmaria Cammarota

Principal Investigator, MD of ICU staff

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

A.O.U Maggiore della Carità

Novara, , Italy

Countries

Italy

References

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.

Reference Type: BACKGROUND

PMID: 3144222 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 33906957 (View on PubMed)

Other Identifiers

CE 23/19

Identifier Type: -

Identifier Source: org_study_id