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CompletedNCT02732041Updated Jan 6, 2020

Asynchrony During Mechanical Ventilation in Patients With Acute Respiratory Distress Syndrome

An observational study in Respiratory Distress Syndrome, Adult and Ventilator-Induced Lung Injury, sponsored by Centro de Educación Medica e Investigaciones Clínicas Norberto Quirno. Completed at 5 sites in Argentina. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2020-01-06.

Sponsored by Centro de Educación Medica e Investigaciones Clínicas Norberto Quirno · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
103
Ages
18 Years to 100 Years
Sex
All
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Study 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.

Read the 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.

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Conditions studied

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In context

Respiratory Distress Syndrome

1,597 studies on the registry are indexed under Respiratory Distress Syndrome; 312 are open to participants now.

This study's enrollment of 103 is close to the median of 100 across 540 observational studies indexed under Respiratory Distress Syndrome.

Browse Respiratory Distress Syndrome studies →

Lead sponsor

Centro de Educación Medica e Investigaciones Clínicas Norberto Quirno is the lead sponsor of 6 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Known severe neuromuscular disease
  • Continuous neuromuscular blocking agents infusion
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
103 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna
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What researchers measure

Primary outcomes

  1. Asynchrony rate

    Asynchronies per minutes of mechanical ventilation

    Time frame: 30 minutes

Secondary outcomes

  1. Length of mechanical ventilation

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

  2. ICU mortality

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

  3. Hospital mortality

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

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Study locations

5 sites
  • Complejo Medico Churruca Visca
    Ciudad Autonoma Buenos Aires, Buenos Aires, Argentina
  • Hospital Italiano de Buenos Aires
    Ciudad Autonoma Buenos Aires, Buenos Aires, Argentina
  • Sanatorio Anchorena
    Ciudad Autonoma Buenos Aires, Buenos Aires, Argentina
  • Sanatorio La Trinidad Mitre
    Ciudad Autonoma Buenos Aires, Buenos Aires, Argentina
  • CEMIC (Centro de Educación Médica e Investigaciones Clínicas)
    Caba, 1431, Argentina
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References and documents

Publications

  • 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. PubMed 32805238 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 6, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02732041
Lead sponsor
Centro de Educación Medica e Investigaciones Clínicas Norberto Quirno
Responsible party
Pablo Oscar Rodriguez (Assosiated Professor, Centro de Educación Medica e Investigaciones Clínicas Norberto Quirno) — Principal investigator
First posted
Apr 8, 2016
Start date
May 25, 2016
Primary completion
Nov 22, 2018
Completion
Feb 2019
Last update
Jan 6, 2020

Study contacts

Pablo O Rodriguez, MD
principal investigator · Centro de Educación Medica e Investigaciones Clínicas Norberto Quirno

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.

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