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

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

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.

Study Overview

• Status: Unknown
• Conditions: Acute Respiratory Failure; Non-invasive Ventilation
• Intervention / Treatment: Other: Post-extubation TDI

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.

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Gianmaria Cammarota, MD,PHD; Phone Number: 00393392669420; Email: gmcamma@gmail.com
• Study Contact Backup: Name: Gianmaria MD Cammarota; Phone Number: 00393392669420

Study Locations

• Italy
  • Novara, Italy, 28100
    • Recruiting
    • A.O.U Maggiore della Carità
    • Contact: Gianmaria Cammarota, MD, PHD; Phone Number: +393213733406; Email: gmcamma@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: diaphragmatic tissue doppler evaluation; 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	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Gas exchange - arterial carbon dioxide tension	PaCO2, will be obtained performing ABG sample	through each trial completion, an average of 20 minutes
Gas exchange - pH	pH will be obtained performing ABGs.	through each trial completion, an average of 20 minutes
Gas exchange - arterial oxygen tension	arterial oxygenation PaO2 will be obtained performing ABGs.	through each trial completion, an average of 20 minutes
Dyspnea level	dyspnea level evaluated through visual analogical scale ( VAS dyspnea)	through each trial completion, an average of 20 minutes
Comfort level	Comfort level evaluated through Comfort Scale	through each trial completion, an average of 20 minutes
Hemodynamic parameters, Heart Rate (HR)	Heart Rate (HR)	athrough each trial completion, an average of 20 minutes
Blood Pressure (BP)	invasive Mean arterial Blood Pressure	through each trial completion, an average of 20 minutes

Collaborators and Investigators

• Sponsor: Azienda Ospedaliero Universitaria Maggiore della Carita

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 1, 2019
• Primary Completion (ANTICIPATED): December 12, 2019
• Study Completion (ANTICIPATED): April 1, 2020

Study Registration Dates

• First Submitted: May 13, 2019
• First Submitted That Met QC Criteria: June 4, 2019
• First Posted (ACTUAL): June 7, 2019

Study Record Updates

• Last Update Posted (ACTUAL): July 23, 2019
• Last Update Submitted That Met QC Criteria: July 21, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: Non invasive ventilation; Spontaneous breathing; Diaphragmatic Tissue Doppler; Post-extubation
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Respiratory Aspiration; Respiratory Insufficiency
• Other Study ID Numbers: CE 22/19

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No