Clinical trial NCT02732041: Asynchrony During Mechanical Ventilation in Patients With Acute Respiratory Distress Syndrome
Official title: Asynchrony During Mechanical Ventilation in Patients With Acute Respiratory Distress Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Respiratory Distress Syndrome, Adult
Ventilator-Induced Lung Injury
Lead sponsor: Centro de Educación Medica e Investigaciones Clínicas Norberto Quirno
Sponsor class: OTHER
First posted: 2016-04-08
Enrollment: 103
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with diagnosis of acute respiratory distress syndrome and mechanical ventilation for less than 72 hours

Brief summary: Asynchrony during mechanical ventilation has been poorly described in patients suffering from acute respiratory distress syndrome. The purpose of this study is to describe the frequency of asynchronies (ineffective efforts and double triggering) in these group and evaluate potential risk factors and prognosis implications.

Detailed description: Major patient-ventilator asynchronies have been described during assisted mechanical ventilation in different settings. Few studies have evaluated double cycling in ARDS patient. No clear predictors of this finding beside low tidal volume have been found, and clinical outcome implications have not been addressed. This study has 3 main objectives: evaluate the frequency of double cycling and ineffective efforts, seek for potential predictors and clinical outcomes related to asynchronies. Subjects with less than 72 hours of mechanical ventilation due to ARDS will be recruited. Thirty minutes of mechanical ventilation will be recorded and automatically analyzed with a custom-made program to detect asynchronies. A blood sample will be drawn to measure inflammatory and lung tissue damage biomarkers. Clinical and outcome data will be recorded.

Eligibility criteria: Inclusion Criteria:

* Acute Respiratory Distress Syndrome according to Berlin definition
* Intubation and mechanical ventilation within 72 hours of inclusion

Exclusion Criteria:

* Known severe neuromuscular disease
* Continuous neuromuscular blocking agents infusion

Primary outcomes:
measure: Asynchrony rate
timeFrame: 30 minutes
Secondary outcomes:
measure: Length of mechanical ventilation
timeFrame: From the date of intubation to the date of complete weaning from mechanical ventilation or death which ever comes first, up to 90 days
measure: ICU mortality
timeFrame: From the date of admission to the date of discharge from the ICU, up to 90 days
measure: Hospital mortality
timeFrame: From the date of admission to the date of discharge from the ICU, up to 90 days
Other outcomes:
Locations:
city: Ciudad Autonoma Buenos Aires
country: Argentina
facility: Complejo Medico Churruca Visca
state: Buenos Aires
city: Ciudad Autonoma Buenos Aires
country: Argentina
facility: Hospital Italiano de Buenos Aires
state: Buenos Aires
city: Ciudad Autonoma Buenos Aires
country: Argentina
facility: Sanatorio Anchorena
state: Buenos Aires
city: Ciudad Autonoma Buenos Aires
country: Argentina
facility: Sanatorio La Trinidad Mitre
state: Buenos Aires
city: Caba
country: Argentina
facility: CEMIC (Centro de Educación Médica e Investigaciones Clínicas)
Study officials:
affiliation: Centro de Educación Medica e Investigaciones Clínicas Norberto Quirno
name: Pablo O Rodriguez, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rodriguez PO, Tiribelli N, Fredes S, Gogniat E, Plotnikow G, Fernandez Ceballos I, Pratto R, Raimondi A, Guaymas M, Ilutovich S, San Roman E, Madorno M, Maskin P, Brochard L, Setten M; Grupo Argentino de Estudio de Asincronias en la Ventilacion Mecanica Study Group. Prevalence of Reverse Triggering in Early ARDS: Results From a Multicenter Observational Study. Chest. 2021 Jan;159(1):186-195. doi: 10.1016/j.chest.2020.08.018. Epub 2020 Aug 14.