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Asynchrony During Mechanical Ventilation in Patients With Acute Respiratory Distress Syndrome

NCT ID: NCT02732041

Last Updated: 2020-01-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

103 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-05-25

Study Completion Date

2019-02-28

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Respiratory Distress Syndrome, Adult Ventilator-Induced Lung Injury

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centro de Educación Medica e Investigaciones Clínicas Norberto Quirno

OTHER

Sponsor Role lead

Responsible Party

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Pablo Oscar Rodriguez

Assosiated Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Pablo O Rodriguez, MD

Role: PRINCIPAL_INVESTIGATOR

Centro de Educación Medica e Investigaciones Clínicas Norberto Quirno

Locations

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Complejo Medico Churruca Visca

Ciudad Autonoma Buenos Aires, Buenos Aires, Argentina

Site Status

Hospital Italiano de Buenos Aires

Ciudad Autonoma Buenos Aires, Buenos Aires, Argentina

Site Status

Sanatorio Anchorena

Ciudad Autonoma Buenos Aires, Buenos Aires, Argentina

Site Status

Sanatorio La Trinidad Mitre

Ciudad Autonoma Buenos Aires, Buenos Aires, Argentina

Site Status

CEMIC (Centro de Educación Médica e Investigaciones Clínicas)

CABA, , Argentina

Site Status

Countries

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Argentina

References

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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.

Reference Type DERIVED
PMID: 32805238 (View on PubMed)

Other Identifiers

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CEMIC1008

Identifier Type: -

Identifier Source: org_study_id

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