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Tissue Doppler Ultrasound During Spontaneous Breathing and Non-invasive Ventilation in the Post-extubation Period.

Diaphragm Performance Evaluation With Tissue Doppler Ultrasound Examination During Spontaneous Breathing in Facial Mask and During Non-invasive Ventilation in the Post-extubation Period.

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03978221
Acronym
TDIpostext
Enrollment
20
Registered
2019-06-07
Start date
2019-04-01
Completion date
2020-04-01
Last updated
2019-07-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Respiratory Failure, Non-invasive Ventilation

Keywords

Diaphragmatic Tissue Doppler, Non invasive ventilation, Spontaneous breathing, Post-extubation

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.

Interventions

OTHERPost-extubation TDI

A diaphragmatic tissue Doppler evaluation will be performed during non-invasive ventilation and spontaneous breathing trial applied in random sequence. Each trial will last 20 minutes. During the last minute of each trial a tissue doppler diaphragmatic examination will be performed to assess the speed of diaphragmatic displacement during inspiration and expiration.

Sponsors

Azienda Ospedaliero Universitaria Maggiore della Carita
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Single Group Assignment

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
diaphragmatic displacement velocitythrough each trial completion, an average of 20 minutesInspiratory and expiratory diaphragmatic displacement velocity evaluated with tissue doppler during the NIV trial and in spontaneous breathing with Venturi mask.

Secondary

MeasureTime frameDescription
Gas exchange - arterial carbon dioxide tensionthrough each trial completion, an average of 20 minutesPaCO2, will be obtained performing ABG sample
Gas exchange - pHthrough each trial completion, an average of 20 minutespH will be obtained performing ABGs.
Gas exchange - arterial oxygen tensionthrough each trial completion, an average of 20 minutesarterial oxygenation PaO2 will be obtained performing ABGs.
Diaphragmatic accelerationthrough each trial completion, an average of 20 minutesInspiratory and expiratory diaphragmatic displacement acceleration evaluated with tissue doppler during the NIV trial and in spontaneous breathing with Venturi mask.
Comfort levelthrough each trial completion, an average of 20 minutesComfort level evaluated through Comfort Scale
Hemodynamic parameters, Heart Rate (HR)athrough each trial completion, an average of 20 minutesHeart Rate (HR)
Blood Pressure (BP)through each trial completion, an average of 20 minutesinvasive Mean arterial Blood Pressure
Dyspnea levelthrough each trial completion, an average of 20 minutesdyspnea level evaluated through visual analogical scale ( VAS dyspnea)

Countries

Italy

Contacts

Primary ContactGianmaria Cammarota, MD,PHD
gmcamma@gmail.com00393392669420
Backup ContactGianmaria MD Cammarota
00393392669420

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026