Clinical trial NCT02687802: Respiratory Mechanics and Patient-ventilator Asynchrony Index in Patients With Invasive Mechanical Ventilation
Official title: Respiratory Mechanics and Patient-ventilator Asynchrony Index in Patients With Invasive Mechanical Ventilation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Respiratory Insufficiency
Keywords: respiratory mechanics
Respiratory Insufficiency
artificial, ventilation
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2016-02-22
Enrollment: 103
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients intubated and under invasive mechanical ventilation in a University hospital ICU

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.

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

Eligibility 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

Primary outcomes:
measure: asynchrony index
timeFrame: from study inclusion until the date of extubation or date of death from any cause, whichever comes first, up to 28 days
Secondary outcomes:
measure: Clinical signs of patient-ventilator asynchrony
timeFrame: daily, from study inclusion until the date of extubation or date of death from any cause, whichever comes first, up to 28 days
measure: ventilation free-days
timeFrame: 28 days
measure: tracheostomy rate
timeFrame: up to 90 days
measure: Survival rate
timeFrame: at 28 and 90 days
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Hospital das Clínicas -HCFMUSP
state: SP
Study officials:
affiliation: Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo
name: Juliana C Ferreira, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sousa MLA, Magrans R, Hayashi FK, Blanch L, Kacmarek RM, Ferreira JC. Predictors of asynchronies during assisted ventilation and its impact on clinical outcomes: The EPISYNC cohort study. J Crit Care. 2020 Jun;57:30-35. doi: 10.1016/j.jcrc.2020.01.023. Epub 2020 Jan 21.
citation: Sousa MLA, Magrans R, Hayashi FK, Blanch L, Kacmarek RM, Ferreira JC. EPISYNC study: predictors of patient-ventilator asynchrony in a prospective cohort of patients under invasive mechanical ventilation - study protocol. BMJ Open. 2019 May 22;9(5):e028601. doi: 10.1136/bmjopen-2018-028601.