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.

Sponsors

Lead Sponsor: Azienda Ospedaliero Universitaria Maggiore della Carita

Source Azienda Ospedaliero Universitaria Maggiore della Carita
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.

Overall Status Recruiting
Start Date April 1, 2019
Completion Date April 1, 2020
Primary Completion Date December 12, 2019
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
diaphragmatic displacement velocity through each trial completion, an average of 20 minutes
Secondary Outcome
Measure Time Frame
Diaphragmatic acceleration 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 minutes
Dyspnea level through each trial completion, an average of 20 minutes
Comfort level through each trial completion, an average of 20 minutes
Hemodynamic parameters, Heart Rate (HR) athrough each trial completion, an average of 20 minutes
Blood Pressure (BP) through each trial completion, an average of 20 minutes
Enrollment 20
Condition
Intervention

Intervention Type: Other

Intervention Name: Post-extubation TDI

Description: 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.

Arm Group Label: diaphragmatic tissue doppler evaluation

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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Contact

Last Name: Gianmaria Cammarota, MD,PHD

Phone: 00393392669420

Email: [email protected]

Location
Facility: Status: Contact: A.O.U Maggiore della Carità Gianmaria Cammarota, MD, PHD +393213733406 [email protected]
Location Countries

Italy

Verification Date

May 2019

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Azienda Ospedaliero Universitaria Maggiore della Carita

Investigator Full Name: Gianmaria Cammarota

Investigator Title: Principal Investigator, MD of ICU staff

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Label: diaphragmatic tissue doppler evaluation

Type: Experimental

Description: A tissue Doppler evaluation, using a sectorial probe, will be performed by analyzing the diaphragmatic displacement velocity during inspiration and expiration randomly assessed in spontaneous breathing with Venturi Mask and in Non-invasive ventilation with a helmet or facial mask

Acronym TDIpostext
Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Intervention Model Description: Single Group Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov