Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

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

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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Recruiting NCT05144633 - Blue Protocol and Eko Artificial Intelligence Are Best (BEA-BEST)
Completed NCT04534569 - Expert Panel Statement for the Respiratory Management of COVID-19 Related Acute Respiratory Failure (C-ARF)
Recruiting NCT03021902 - Nutrition and Exercise in Critical Illness Phase 2
Completed NCT02902146 - Bougie Use in Emergency Airway Management N/A
Completed NCT02901158 - Esophageal Manometry in Mechanically Ventilated Patients
Completed NCT02236559 - High Flow Therapy for the Treatment of Respiratory Failure in the ED N/A
Recruiting NCT02056093 - Comparison of Proportional Assist Ventilation And Neurally Adjusted Ventilator Assist N/A
Terminated NCT01083277 - Variable Ventilation During Acute Respiratory Failure N/A
Not yet recruiting NCT01668368 - Goal Directed Mechanical Ventilation Aimed at Optimal Lung Compliance N/A
Completed NCT01462279 - Effect of Thiamine on Oxygen Utilization (VO2) in Critical Illness N/A
Completed NCT01114022 - Prevention Inhalation of Bacterial by Using Endotracheal Tube Balloon Polyvinyl Chloride or Polyurethane N/A
Active, not recruiting NCT01058421 - Treatment of Critical Illness Polyneuromyopathy Phase 2
Completed NCT00252616 - Timing of Target Enteral Feeding in the Mechanically Ventilated Patient Phase 2/Phase 3
Recruiting NCT04098094 - Outcomes of RV Dysfunction in Acute Exacerbation of Chronic Respiratory Diseases
Recruiting NCT06051292 - Decremental Esophageal Catheter Filling Volume Titration For Transpulmonary Pressure Measurement N/A
Completed NCT04601090 - Survival Rates and Longterm Outcomes After COVID-19
Recruiting NCT05423301 - Global Physiotherapy in ICU Patients With High Risk Extubation Failure N/A
Completed NCT02447692 - Proportional Assist Ventilation for Minimizing the Duration of Mechanical Ventilation: The PROMIZING Study N/A
Completed NCT04016480 - HFNC During Bronchoscopy for Bronchoalveolar Lavage N/A
Completed NCT04507425 - High Flow Nasal Cannula With Noninvasive Ventilation N/A