Respiratory Distress Syndrome, AdultNCT02732041
Asynchrony During Mechanical Ventilation in Patients With Acute Respiratory Distress Syndrome
An observational study of Respiratory Distress Syndrome, Adult and Ventilator-Induced Lung Injury, run by Centro de Educación Medica e Investigaciones Clínicas Norberto Quirno at 5 sites in Argentina.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Respiratory Distress Syndrome, Adult, Ventilator-Induced Lung Injury
- How many people
- 103 participants
- Where
- 5 sitesArgentina
- Study dates
- 25 May 2016to Feb 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with diagnosis of acute respiratory distress syndrome and mechanical ventilation for less than 72 hours
Who may be able to join
- Acute Respiratory Distress Syndrome according to Berlin definition
- Intubation and mechanical ventilation within 72 hours of inclusion
Who cannot join
- Known severe neuromuscular disease
- Continuous neuromuscular blocking agents infusion
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Argentina5 sites
CEMIC (Centro de Educación Médica e Investigaciones Clínicas)
CABA, 1431
Complejo Medico Churruca Visca
Ciudad Autonoma Buenos Aires, Buenos Aires
Hospital Italiano de Buenos Aires
Ciudad Autonoma Buenos Aires, Buenos Aires
Sanatorio Anchorena
Ciudad Autonoma Buenos Aires, Buenos Aires
Sanatorio La Trinidad Mitre
Ciudad Autonoma Buenos Aires, Buenos Aires
About this study
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.
- Medical subject headings
- Respiratory Distress Syndrome, Ventilator-Induced Lung Injury
What is being measured
The primary outcome is the main question the study is designed to answer.
Asynchrony rate
Asynchronies per minutes of mechanical ventilation
Measured: 30 minutes
Secondary outcomes (3)
Length of mechanical ventilation
Measured: 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
Measured: From the date of admission to the date of discharge from the ICU, up to 90 days
Hospital mortality
Measured: From the date of admission to the date of discharge from the ICU, up to 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2016 (estimated)
- Study start25 May 2016
- Primary completion22 Nov 2018
- Study completionFeb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Respiratory Distress Syndrome, AdultStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centro de Educación Medica e Investigaciones Clínicas Norberto Quirno
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pablo Oscar Rodriguez, Centro de Educación Medica e Investigaciones Clínicas Norberto Quirno
- Investigators
- Pablo O Rodriguez, MD, Principal investigator, Centro de Educación Medica e Investigaciones Clínicas Norberto Quirno
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02732041
- Sponsor's protocol ID
- CEMIC1008
- Status last verified
- Jan 2020
- First submitted
- 19 Mar 2016
- Last updated
- 6 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Asynchrony During Mechanical Ventilation in Patients With Acute Respiratory Distress Syndrome
- ClinicalTrials.gov ID
- NCT02732041
- Acronym / sponsor ID
- CEMIC1008
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Centro de Educación Medica e Investigaciones Clínicas Norberto QuirnoUniversity, hospital or other
- Study start
- 25 May 2016 (actual)
- Primary completion
- 22 Nov 2018 (actual)
- Study completion
- Feb 2019 (actual)
- First posted
- 8 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with diagnosis of acute respiratory distress syndrome and mechanical ventilation for less than 72 hours
Key inclusion criteria (2 listed)
- Acute Respiratory Distress Syndrome according to Berlin definition
- Intubation and mechanical ventilation within 72 hours of inclusion
Key exclusion criteria (2 listed)
- Known severe neuromuscular disease
- Continuous neuromuscular blocking agents infusion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Asynchrony rate
Time frame: 30 minutes
Asynchronies per minutes of mechanical ventilation
3 secondary outcomes
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
ICU mortality
Time frame: From the date of admission to the date of discharge from the ICU, up to 90 days
Hospital mortality
Time frame: From the date of admission to the date of discharge from the ICU, up to 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2020.
- Derived from this study: PubMed 32805238Rodriguez 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pablo O Rodriguez, MD principal investigator
Centro de Educación Medica e Investigaciones Clínicas Norberto Quirno
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Distress Syndrome, Adult and Ventilator-Induced Lung Injury, run by Centro de Educación Medica e Investigaciones Clínicas Norberto Quirno at 5 sites in Argentina.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Asynchrony rate (time frame: 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02732041, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2020.