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NCT Number: NCT02687802

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

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.

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Key information

Conditions

Respiratory Insufficiency Pathologic Processes Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Aspiration Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital das Clínicas -HCFMUSP

São Paulo, 05403010, Brazil

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mechanical ventilation

Other

we will measure static resistance, compliance and intrinsic positive end-expiratory pressure (PEEP) and other variables as risk factors for asynchrony occurrence

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Sao Paulo General Hospital

Other

Collaborators

  • Fundação de Amparo à Pesquisa do Estado de São Paulo

Registry information

Acronym: EpiSync

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Feb 22, 2016
Registry last updated
Jun 11, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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