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Respiratory Mechanics and Patient-ventilator Asynchrony Index in Patients With Invasive Mechanical Ventilation (EpiSync)

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ClinicalTrials.gov Identifier: NCT02687802
Recruitment Status : Recruiting
First Posted : February 22, 2016
Last Update Posted : May 8, 2018
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by (Responsible Party):
University of Sao Paulo General Hospital

Brief Summary:
The objective of the study is to estimate the incidence of asynchrony and to assess its relationship with respiratory mechanics. This will be a prospective cohort study, including patients under invasive mechanical ventilation. Within 48h post intubation, the investigators will record the values of intrinsic positive end-expiratory pressure, pulmonary compliance and resistance. Participants will be followed up from intubation to mechanical ventilation liberation. The investigators will register clinical signs of asynchrony and record ventilator waveforms continuously and quantify patient-ventilator asynchrony. The investigators will calculate the total asynchrony index (AI) and of each asynchrony type (ineffective triggering, double triggering, auto triggering, short cycling and prolonged cycling). Participants will be followed up until hospital discharge.

Condition or disease Intervention/treatment
Respiratory Insufficiency Other: mechanical ventilation

Detailed Description:
Patient-ventilator asynchrony is common in patients under invasive mechanical ventilation, present between 10 and 80% of all respiratory cycles, and is associated with adverse clinical outcomes, such as delay in the weaning process, increased complications of mechanical ventilation, with possible impact on survival. The objective of this study is to estimate the incidence of asynchrony and to assess its relationship with respiratory mechanics. This will be a prospective cohort study, including all patients under invasive mechanical ventilation admitted at Respiratory ICU at Hospital das Clínicas da Faculdade de Medicina da Universidade de Sao Paulo (USP), during the study period. Within 48h post intubation, the investigators will record the values of intrinsic positive end-expiratory pressure, pulmonary compliance and resistance. Participants will be followed up from intubation to mechanical ventilation liberation. The investigators will register clinical signs of asynchrony and record ventilator waveforms continuously. The ventilator waveforms will be captured directly from ventilator and processed by dedicated software, without direct contact with patients. Later, ventilator waveforms will be analyzed to quantify patient-ventilator asynchrony. The investigators will calculate the total asynchrony index (AI) and of each asynchrony type (ineffective triggering, double triggering, auto triggering, short cycling and prolonged cycling). Participants will be followed up until hospital discharge, and the investigators will record duration of mechanical ventilation, the use of non-invasive ventilation post-extubation, reintubation, tracheostomy, ICU and hospital length of stay and survival. With this project, the investigators will estimate the incidence and magnitude of patient-ventilator asynchrony and its association with clinical outcomes

Study Type : Observational
Estimated Enrollment : 110 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Respiratory Mechanics and Patient-ventilator Asynchrony Index in Patients With Invasive Mechanical Ventilation
Study Start Date : August 2016
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Mechanical ventilation
Patients under mechanical ventilation for more than 24h
Other: mechanical ventilation
we will measure static resistance, compliance and intrinsic positive end-expiratory pressure (PEEP) and other variables as risk factors for asynchrony occurrence




Primary Outcome Measures :
  1. asynchrony index [ Time Frame: from study inclusion until the date of extubation or date of death from any cause, whichever comes first, up to 28 days ]
    asynchrony index will be calculated as the number of major asynchrony events divided by total number of respiratory cycles


Secondary Outcome Measures :
  1. Clinical signs of patient-ventilator asynchrony [ Time Frame: daily, from study inclusion until the date of extubation or date of death from any cause, whichever comes first, up to 28 days ]
    a standardized questionnaire will be used to evaluate the presence of clinically significant patient-ventilator asynchrony. Trained investigators will observe participant´s breathing pattern and other clinical signs of patient-ventilator asynchrony and score each item as absent (0) or present (1). Then, they will visual inspection of ventilator waveforms on the ventilator screen for a 5 minute observation period, looking for missed efforts, double triggering, auto-triggering, cycling delay and premature cycling, as previously defined. If they observe more than 1 asynchrony event for every 10 respiratory cycles, they will rate this item as present (1), otherwise, they will rate it as absent (0).

  2. ventilation free-days [ Time Frame: 28 days ]
    number of days alive and off the ventilator up to day 28

  3. tracheostomy rate [ Time Frame: up to 90 days ]
    performance of surgical or bronchoscopy-guided tracheotomy

  4. Survival rate [ Time Frame: at 28 and 90 days ]
    survival from intubation up to 90 days



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients intubated and under invasive mechanical ventilation in a University hospital ICU
Criteria

Inclusion Criteria:

  • Recent mechanical ventilation (less than 72 hours)
  • Expectation of mechanical ventilation for more than 24 hours
  • Age ≥ 18 years old

Exclusion Criteria:

  • High flow Bronchopleural fistula
  • Thoracic or abdominal deformities that could compromise the accuracy of respiratory mechanics measurement
  • Impossibility to measure respiratory mechanics
  • Tracheostomy

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): NCT02687802


Contacts
Contact: Juliana C Ferreira, MD +5511983355876 juliana.ferreira@hc.fm.usp.br
Contact: Mayson L Sousa, RRT +5511985519000 mayson.laercio@hc.fm.usp.br

Locations
Brazil
Hospital das Clínicas -HCFMUSP Recruiting
Sao Paulo, SP, Brazil, 05403010
Contact: Juliana C Ferreira, MD    +5511983355876      
Sponsors and Collaborators
University of Sao Paulo General Hospital
Fundação de Amparo à Pesquisa do Estado de São Paulo
Investigators
Principal Investigator: Juliana C Ferreira, MD Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo

Responsible Party: University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT02687802     History of Changes
Other Study ID Numbers: 2015/19122-4
First Posted: February 22, 2016    Key Record Dates
Last Update Posted: May 8, 2018
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No individual personal data will be disclosed

Keywords provided by University of Sao Paulo General Hospital:
respiratory mechanics
Respiratory Insufficiency
artificial, ventilation

Additional relevant MeSH terms:
Respiratory Insufficiency
Pulmonary Valve Insufficiency
Respiration Disorders
Respiratory Tract Diseases
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases