Clinical trial NCT03978221: Tissue Doppler Ultrasound During Spontaneous Breathing and Non-invasive Ventilation in the Post-extubation Period.
Official title: Diaphragm Performance Evaluation With Tissue Doppler Ultrasound Examination During Spontaneous Breathing in Facial Mask and During Non-invasive Ventilation in the Post-extubation Period.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acute Respiratory Failure
Non-invasive Ventilation
Keywords: Diaphragmatic Tissue Doppler
Non invasive ventilation
Spontaneous breathing
Post-extubation
Lead sponsor: Azienda Ospedaliero Universitaria Maggiore della Carita
Sponsor class: OTHER
First posted: 2019-06-07
Enrollment: 20
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: The aim of the present investigation will be to evaluate diaphragmatic excursion velocity during non-invasive ventilation and spontaneous breathing at both inspiration and expiration.

this analysis will be performed through diaphragmatic tissue Doppler assessment.

Detailed description: Early weaning from invasive ventilation, in patients admitted to intensive care, is associated with a marked reduction in ventilator-associated pneumonia, length of stay in intensive care unit and hospital, total duration of mechanical ventilation and decrease in overall mortality. Moreover, in case of need of protected extubation, non-invasive ventilation has allowed to prevent re-intubation and decrease hospital mortality compared to the simple administration of oxygen through a facial mask, in particular when applied immediately after extubation.

The diaphragmatic tissue doppler imaging (TDI) is an ultrasonographic technique derived from ultrasound evaluation of the heart's motility. It can be easily used on the diaphragm to calculate the speed of muscles displacement that could be associated with patient's respiratory drive.

The aim of the study is the evaluation of the diaphragmatic excursion velocity variations using diaphragmatic tissue doppler, measured in venturi mask and non-invasive ventilation in the post-extubation period, in order to compare the diaphragm stress variations during the two different modes.

Method Patients after extubation will be randomly submitted to a spontaneous breathing test in venturi mask and in facemask or helmet NIV.

Each trial will last 20 minutes. During the last minute of each trial a tissue doppler diaphragm examination will be performed to assess the speed speed of muscle displacement, acceleration and deceleration.

Inclusion criteria: invasive mechanical ventilation \> 24h with consequent extubation.

Exclusion criteria: refusal to grant consent, pregnancy, age \< 18 years, haemodynamic instability, difficult management of secretions, required inotropic and / or vasoactive drugs at high doses.

During the study, vital parameters will be given.

Eligibility criteria: Inclusion Criteria:

* invasive mechanical ventilation \> 24h with consequent extubation

Exclusion Criteria:

* refusal to grant consent
* pregnancy
* age \>18 years
* haemodynamic instability
* difficult management of secretions
* required inotropic and / or vasoactive drugs at high doses

Primary outcomes:
measure: diaphragmatic displacement velocity
timeFrame: through each trial completion, an average of 20 minutes
Secondary outcomes:
measure: Diaphragmatic acceleration
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 minutes
measure: Dyspnea level
timeFrame: through each trial completion, an average of 20 minutes
measure: Comfort level
timeFrame: through each trial completion, an average of 20 minutes
measure: Hemodynamic parameters, Heart Rate (HR)
timeFrame: athrough each trial completion, an average of 20 minutes
measure: Blood Pressure (BP)
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: Vaschetto R, Longhini F, Persona P, Ori C, Stefani G, Liu S, Yi Y, Lu W, Yu T, Luo X, Tang R, Li M, Li J, Cammarota G, Bruni A, Garofalo E, Jin Z, Yan J, Zheng R, Yin J, Guido S, Della Corte F, Fontana T, Gregoretti C, Cortegiani A, Giarratano A, Montagnini C, Cavuto S, Qiu H, Navalesi P. Early extubation followed by immediate noninvasive ventilation vs. standard extubation in hypoxemic patients: a randomized clinical trial. Intensive Care Med. 2019 Jan;45(1):62-71. doi: 10.1007/s00134-018-5478-0. Epub 2018 Dec 10.