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

Acute Respiratory Failure Clinical Trial

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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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03978221
• Other study ID #: CE 22/19
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2019
• Est. completion date: April 1, 2020

Study information

• Verified date: May 2019
• Source: Azienda Ospedaliero Universitaria Maggiore della Carita
• Contact: Gianmaria Cammarota, MD,PHD
• Phone: 00393392669420
• Email: gmcamma[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Acute Respiratory Failure
• Non-invasive Ventilation
• Respiratory Aspiration
• Respiratory Distress Syndrome, Adult
• Respiratory Insufficiency

Intervention

Other:
• Post-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.

Locations

Country	Name	City	State
Italy	A.O.U Maggiore della Carità	Novara

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliero Universitaria Maggiore della Carita

Country where clinical trial is conducted

Italy, 

References & Publications (1)

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

Outcome

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