Tissue Doppler Ultrasound During Spontaneous Breathing and Non-invasive Ventilation in the Post-extubation Period. (TDIpostext)
Primary Purpose
Acute Respiratory Failure, Non-invasive Ventilation
Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Post-extubation TDI
Sponsored by
About this trial
This is an interventional treatment trial for Acute Respiratory Failure focused on measuring Diaphragmatic Tissue Doppler, Non invasive ventilation, Spontaneous breathing, Post-extubation
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
Sites / Locations
- A.O.U Maggiore della CaritàRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
diaphragmatic tissue doppler evaluation
Arm 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
Outcomes
Primary Outcome Measures
diaphragmatic displacement velocity
Inspiratory and expiratory diaphragmatic displacement velocity evaluated with tissue doppler during the NIV trial and in spontaneous breathing with Venturi mask.
Secondary Outcome Measures
Diaphragmatic acceleration
Inspiratory and expiratory diaphragmatic displacement acceleration evaluated with tissue doppler during the NIV trial and in spontaneous breathing with Venturi mask.
Gas exchange - arterial carbon dioxide tension
PaCO2, will be obtained performing ABG sample
Gas exchange - pH
pH will be obtained performing ABGs.
Gas exchange - arterial oxygen tension
arterial oxygenation PaO2 will be obtained performing ABGs.
Dyspnea level
dyspnea level evaluated through visual analogical scale ( VAS dyspnea)
Comfort level
Comfort level evaluated through Comfort Scale
Hemodynamic parameters, Heart Rate (HR)
Heart Rate (HR)
Blood Pressure (BP)
invasive Mean arterial Blood Pressure
Full Information
NCT ID
NCT03978221
First Posted
May 13, 2019
Last Updated
July 21, 2019
Sponsor
Azienda Ospedaliero Universitaria Maggiore della Carita
1. Study Identification
Unique Protocol Identification Number
NCT03978221
Brief Title
Tissue Doppler Ultrasound During Spontaneous Breathing and Non-invasive Ventilation in the Post-extubation Period.
Acronym
TDIpostext
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
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Unknown status
Study Start Date
April 1, 2019 (Actual)
Primary Completion Date
December 12, 2019 (Anticipated)
Study Completion Date
April 1, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Azienda Ospedaliero Universitaria Maggiore della Carita
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Respiratory Failure, Non-invasive Ventilation
Keywords
Diaphragmatic Tissue Doppler, Non invasive ventilation, Spontaneous breathing, Post-extubation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
diaphragmatic tissue doppler evaluation
Arm Type
Experimental
Arm 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
Intervention Type
Other
Intervention Name(s)
Post-extubation TDI
Intervention 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.
Primary Outcome Measure Information:
Title
diaphragmatic displacement velocity
Description
Inspiratory and expiratory diaphragmatic displacement velocity evaluated with tissue doppler during the NIV trial and in spontaneous breathing with Venturi mask.
Time Frame
through each trial completion, an average of 20 minutes
Secondary Outcome Measure Information:
Title
Diaphragmatic acceleration
Description
Inspiratory and expiratory diaphragmatic displacement acceleration evaluated with tissue doppler during the NIV trial and in spontaneous breathing with Venturi mask.
Time Frame
through each trial completion, an average of 20 minutes
Title
Gas exchange - arterial carbon dioxide tension
Description
PaCO2, will be obtained performing ABG sample
Time Frame
through each trial completion, an average of 20 minutes
Title
Gas exchange - pH
Description
pH will be obtained performing ABGs.
Time Frame
through each trial completion, an average of 20 minutes
Title
Gas exchange - arterial oxygen tension
Description
arterial oxygenation PaO2 will be obtained performing ABGs.
Time Frame
through each trial completion, an average of 20 minutes
Title
Dyspnea level
Description
dyspnea level evaluated through visual analogical scale ( VAS dyspnea)
Time Frame
through each trial completion, an average of 20 minutes
Title
Comfort level
Description
Comfort level evaluated through Comfort Scale
Time Frame
through each trial completion, an average of 20 minutes
Title
Hemodynamic parameters, Heart Rate (HR)
Description
Heart Rate (HR)
Time Frame
athrough each trial completion, an average of 20 minutes
Title
Blood Pressure (BP)
Description
invasive Mean arterial Blood Pressure
Time Frame
through each trial completion, an average of 20 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gianmaria Cammarota, MD,PHD
Phone
00393392669420
Email
gmcamma@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Gianmaria MD Cammarota
Phone
00393392669420
Facility Information:
Facility Name
A.O.U Maggiore della Carità
City
Novara
ZIP/Postal Code
28100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gianmaria Cammarota, MD, PHD
Phone
+393213733406
Email
gmcamma@gmail.com
12. IPD Sharing Statement
Citations:
PubMed Identifier
30535516
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.
Results Reference
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Tissue Doppler Ultrasound During Spontaneous Breathing and Non-invasive Ventilation in the Post-extubation Period.
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