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Evaluation of an Informative Intervention to the ICU Team About the Presence of Asynchronies in Mechanically Ventilated Patients: Effect Over Incidence Reduction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02714751
Recruitment Status : Completed
First Posted : March 21, 2016
Last Update Posted : April 30, 2019
Sponsor:
Information provided by (Responsible Party):
Lluis Blanch, Corporacion Parc Tauli

Brief Summary:

Mechanical ventilation (MV) if a life-support treatment for critically ill patients that can develop adverse effects. Patient-ventilator asynchronies can be present from the beginning of MV, it can be associated with poor outcome and it can develop clinical changes. The aim of this study is to evaluate if the knowledge of the presence of asynchronies by the healthcare team can help to reduce its incidence, improving outcomes of critically ill patients.

A prospective, single-center, before and after study will be conducted in the ICU of Hospital de Sabadell. The study will have 2 phases: a first observational period where the incidence of asynchronies will be assessed, and a second period where a daily information of the presence of asynchronies to the healthcare team will be done with the aim to reduce the incidence.

A continous record of asynchronies and clinical variables will be done during ICU stay.


Condition or disease Intervention/treatment Phase
Asynchronies Behavioral: Daily asynchronies information Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 166 participants
Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Study Start Date : March 2016
Actual Primary Completion Date : March 2019
Actual Study Completion Date : March 2019

Arm Intervention/treatment
No Intervention: Observational group
Group after information intervention
Control group after daily information to healthcare team
Behavioral: Daily asynchronies information



Primary Outcome Measures :
  1. Incidence of asynchronies [ Time Frame: one year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Invasive mechanical ventilation < 24 hours.
  • > 18 years-old

Exclusion Criteria:

  • > 24 hours of invasive mechanical ventilation at admission.
  • <48 hours of data collected
  • Informed consent not obtained

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02714751


Locations
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Spain
Parc Tauli
Sabadell, Spain
Sponsors and Collaborators
Corporacion Parc Tauli
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Responsible Party: Lluis Blanch, PhD, Corporacion Parc Tauli
ClinicalTrials.gov Identifier: NCT02714751    
Other Study ID Numbers: CIR2015/057
First Posted: March 21, 2016    Key Record Dates
Last Update Posted: April 30, 2019
Last Verified: April 2019