NCT02732041

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
103

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2016

Typical duration for all trials

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 19, 2016

Completed
20 days until next milestone

First Posted

Study publicly available on registry

April 8, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

May 25, 2016

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 22, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2019

Completed
Last Updated

January 6, 2020

Status Verified

January 1, 2020

Enrollment Period

2.5 years

First QC Date

March 19, 2016

Last Update Submit

January 2, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Asynchrony rate

    Asynchronies per minutes of mechanical ventilation

    30 minutes

Secondary Outcomes (3)

  • Length of mechanical ventilation

    From the date of intubation to the date of complete weaning from mechanical ventilation or death which ever comes first, up to 90 days

  • ICU mortality

    From the date of admission to the date of discharge from the ICU, up to 90 days

  • Hospital mortality

    From the date of admission to the date of discharge from the ICU, up to 90 days

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with diagnosis of acute respiratory distress syndrome and mechanical ventilation for less than 72 hours

You may qualify if:

  • Acute Respiratory Distress Syndrome according to Berlin definition

You may not qualify if:

  • Known severe neuromuscular disease
  • Continuous neuromuscular blocking agents infusion

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Complejo Medico Churruca Visca

Ciudad Autonoma Buenos Aires, Buenos Aires, Argentina

Location

Hospital Italiano de Buenos Aires

Ciudad Autonoma Buenos Aires, Buenos Aires, Argentina

Location

Sanatorio Anchorena

Ciudad Autonoma Buenos Aires, Buenos Aires, Argentina

Location

Sanatorio La Trinidad Mitre

Ciudad Autonoma Buenos Aires, Buenos Aires, Argentina

Location

CEMIC (Centro de Educación Médica e Investigaciones Clínicas)

CABA, 1431, Argentina

Location

Related Publications (1)

  • 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.

Biospecimen

Retention: SAMPLES WITHOUT DNA

plasma

MeSH Terms

Conditions

Respiratory Distress SyndromeVentilator-Induced Lung Injury

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiration DisordersLung Injury

Study Officials

  • Pablo O Rodriguez, MD

    Centro de Educación Medica e Investigaciones Clínicas Norberto Quirno

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assosiated Professor

Study Record Dates

First Submitted

March 19, 2016

First Posted

April 8, 2016

Study Start

May 25, 2016

Primary Completion

November 22, 2018

Study Completion

February 1, 2019

Last Updated

January 6, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations