Clinical trial NCT03962322: Diaphragmatic Tissue Doppler During Weaning From Mechanical Ventilation
Official title: Diaphragmatic Tissue Doppler During Weaning From Mechanical Ventilation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Weaning From Mechanical Ventilation
Keywords: Diaphragmatic Tissue Doppler
Weaning
Mechanical ventilation
Lead sponsor: Azienda Ospedaliero Universitaria Maggiore della Carita
Sponsor class: OTHER
First posted: 2019-05-24
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single Group Assignment
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Primary Outcome Measure - Change in diaphragmatic displacement velocity
timeFrame: through each trial completion, an average of 20 minutes
Secondary outcomes:
measure: Diaphragmatic acceleration and deceleration
timeFrame: through each trial completion, an average of 20 minutes
measure: Gas exchange - arterial carbon dioxide tension
timeFrame: through each trial completion, an average of 20 minutes
measure: Gas exchange - pH
timeFrame: through each trial completion, an average of 20 minutes
measure: Gas exchange - arterial oxygen tension
timeFrame: through each trial completion, an average of 20 min
measure: Dyspnea level
timeFrame: through each trial completion, an average of 20 minutes
measure: Heart rate
timeFrame: through each trial completion, an average of 20 minutes
measure: Number of patients who experienced weaning failure
timeFrame: over 48 hours following extubation
measure: Blood Pressure
timeFrame: through each trial completion, an average of 20 minutes
Other outcomes:
Locations:
city: Novara
country: Italy
facility: A.O.U Maggiore della Carità
Study officials:
References:
citation: 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.
citation: 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.