Acute Respiratory Failure Clinical Trial
— TDIpostextOfficial 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.
NCT number | NCT03978221 |
Other study ID # | CE 22/19 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | April 1, 2019 |
Est. completion date | April 1, 2020 |
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.
Status | Recruiting |
Enrollment | 20 |
Est. completion date | April 1, 2020 |
Est. primary completion date | December 12, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Italy | A.O.U Maggiore della Carità | Novara |
Lead Sponsor | Collaborator |
---|---|
Azienda Ospedaliero Universitaria Maggiore della Carita |
Italy,
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | diaphragmatic displacement velocity | Inspiratory and expiratory diaphragmatic displacement velocity evaluated with tissue doppler during the NIV trial and in spontaneous breathing with Venturi mask. | through each trial completion, an average of 20 minutes | |
Secondary | Diaphragmatic acceleration | Inspiratory and expiratory diaphragmatic displacement acceleration evaluated with tissue doppler during the NIV trial and in spontaneous breathing with Venturi mask. | through each trial completion, an average of 20 minutes | |
Secondary | Gas exchange - arterial carbon dioxide tension | PaCO2, will be obtained performing ABG sample | through each trial completion, an average of 20 minutes | |
Secondary | Gas exchange - pH | pH will be obtained performing ABGs. | through each trial completion, an average of 20 minutes | |
Secondary | Gas exchange - arterial oxygen tension | arterial oxygenation PaO2 will be obtained performing ABGs. | through each trial completion, an average of 20 minutes | |
Secondary | Dyspnea level | dyspnea level evaluated through visual analogical scale ( VAS dyspnea) | through each trial completion, an average of 20 minutes | |
Secondary | Comfort level | Comfort level evaluated through Comfort Scale | through each trial completion, an average of 20 minutes | |
Secondary | Hemodynamic parameters, Heart Rate (HR) | Heart Rate (HR) | athrough each trial completion, an average of 20 minutes | |
Secondary | Blood Pressure (BP) | invasive Mean arterial Blood Pressure | through each trial completion, an average of 20 minutes |
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