Respiratory Insufficiency Clinical Trial
— EpiSyncOfficial title:
Respiratory Mechanics and Patient-ventilator Asynchrony Index in Patients With Invasive Mechanical Ventilation
Verified date | June 2019 |
Source | University of Sao Paulo General Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 103 |
Est. completion date | March 31, 2019 |
Est. primary completion date | January 1, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Brazil | Hospital das Clínicas -HCFMUSP | Sao Paulo | SP |
Lead Sponsor | Collaborator |
---|---|
University of Sao Paulo General Hospital | Fundação de Amparo à Pesquisa do Estado de São Paulo |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | asynchrony index | asynchrony index will be calculated as the number of major asynchrony events divided by total number of respiratory cycles | from study inclusion until the date of extubation or date of death from any cause, whichever comes first, up to 28 days | |
Secondary | Clinical signs of patient-ventilator asynchrony | 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). | daily, from study inclusion until the date of extubation or date of death from any cause, whichever comes first, up to 28 days | |
Secondary | ventilation free-days | number of days alive and off the ventilator up to day 28 | 28 days | |
Secondary | tracheostomy rate | performance of surgical or bronchoscopy-guided tracheotomy | up to 90 days | |
Secondary | Survival rate | survival from intubation up to 90 days | at 28 and 90 days |
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