Mechanical Ventilation ComplicationNCT04448782
Characterization of Reverse Triggering and Other Asynchronies in COVID-19 Patients Under Invasive Mechanical Ventilation
An observational study of Mechanical Ventilation Complication, run by Corporacion Parc Tauli at 1 site in Spain.
Trial summary
Prospective observational trial in patients admitted to ICU diagnosed with COVID-19 requiring invasive mechanical ventilation. Characterization of Reverse Triggering asynchrony during the first 5 days of invasive mechanical ventilation and other asynchronies, and its correlation with different outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mechanical Ventilation Complication
- What is being tested?
- Asynchronies detection
- How many people
- 32 participants
- Where
- 1 siteSpain
- Study dates
- 9 Mar 2020to 30 Jun 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients admitted to the ICU under invasive mechanical ventilation with ARDS secondary to COVID-19
Who may be able to join
- Patients under invasive mechanical ventilation more than 24 hours and with a minimum of 48 hours of respiratory signals registered from the ventilator
- Diagnosis of COVID-19
Who cannot join
- less than 48 hours of data,
- age < 18 years
- admitted from other centers under invasive mechanical ventilation.
Trial locations and contacts
1 site in 1 country.
About this study
Prospective observational trial in patients admitted to ICU diagnosed with COVID-19 requiring invasive mechanical ventilation. Characterization of Reverse Triggering asynchrony during the first 5 days of invasive mechanical ventilation and other asynchronies, and its correlation with different outcomes.
- Conditions
- Mechanical Ventilation Complication
- Being tested
- Asynchronies detection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Asynchronies detectionDiagnostic test
Asycnhronies detection
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and pattern of presentation of Reverse triggering in COVID-19 patients under invasive mechanical ventilation
To analyze the incidence of Reverse Triggering in the initial phases of invasive mechanical ventilation in COVID-19 patients
Measured: during the 5 first days of invasive mechanical ventilation
Secondary outcomes (4)
Incidence of Reverse Triggering related to the level of sedation in COVID-19 patients under invasive mechanical ventilation
To correlate the presence of Reverse Triggering with the level of sedation and use of neuromuscular blockers
Measured: From the day of mechanical ventilation initation up to 5 days or the last day of mechanical ventilation
Reverse triggering and secondary asynchronies in COVID-19 patients under invasive mechanical ventilation
To analyze the incidence of breath stacking and ineffective efforts secondary to RT.
Measured: From the day of mechanical ventilation initiation up to 5 days
Incidence and pattern of presentation of asynchronies in COVID-19 patients under invasive mechanical ventilation
To analyze the incidence of RT, ineffective efforts and double triggering throughout the period of invasive mechanical ventilation
Measured: Each day from the day of mechanical ventilation initiation until the day of mechanical ventilation withdrawal or up to 28 days
Influence of asynchronies in different outcomes in in COVID-19 patients under invasive mechanical ventilation
To correlate the presence of asycnhronies and its type with duration of invasive mechanical ventilation, ICU length of stay and survival
Measured: Each day from the day of mechanical ventilation initiation until the end of invasive mechanical ventilation, ICU discharge and hospital discharge or up to 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2020
- Study start9 Mar 2020
- Primary completion30 Jun 2020
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mechanical Ventilation ComplicationStudies 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
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corporacion Parc Tauli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Candelaria de Haro, Corporacion Parc Tauli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04448782
- Sponsor's protocol ID
- RT COVID-19
- Status last verified
- Jul 2020
- First submitted
- 17 Jun 2020
- Last updated
- 14 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of Reverse Triggering and Other Asynchronies in COVID-19 Patients Under Invasive Mechanical Ventilation
- ClinicalTrials.gov ID
- NCT04448782
- Acronym / sponsor ID
- RT COVID-19
- Conditions
- Mechanical Ventilation Complication
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Corporacion Parc TauliUniversity, hospital or other
- Study start
- 9 Mar 2020 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 26 Jun 2020 (actual)
- 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.
Prospective observational trial in patients admitted to ICU diagnosed with COVID-19 requiring invasive mechanical ventilation. Characterization of Reverse Triggering asynchrony during the first 5 days of invasive mechanical ventilation and other asynchronies, and its correlation with different outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients admitted to the ICU under invasive mechanical ventilation with ARDS secondary to COVID-19
Key inclusion criteria (2 listed)
- Patients under invasive mechanical ventilation more than 24 hours and with a minimum of 48 hours of respiratory signals registered from the ventilator
- Diagnosis of COVID-19
Key exclusion criteria (3 listed)
- less than 48 hours of data,
- age < 18 years
- admitted from other centers under invasive mechanical ventilation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Asynchronies detectionAsycnhronies detection | Diagnostic test | – |
Primary outcome
Incidence and pattern of presentation of Reverse triggering in COVID-19 patients under invasive mechanical ventilation
Time frame: during the 5 first days of invasive mechanical ventilation
To analyze the incidence of Reverse Triggering in the initial phases of invasive mechanical ventilation in COVID-19 patients
4 secondary outcomes
Incidence of Reverse Triggering related to the level of sedation in COVID-19 patients under invasive mechanical ventilation
Time frame: From the day of mechanical ventilation initation up to 5 days or the last day of mechanical ventilation
Reverse triggering and secondary asynchronies in COVID-19 patients under invasive mechanical ventilation
Time frame: From the day of mechanical ventilation initiation up to 5 days
Incidence and pattern of presentation of asynchronies in COVID-19 patients under invasive mechanical ventilation
Time frame: Each day from the day of mechanical ventilation initiation until the day of mechanical ventilation withdrawal or up to 28 days
Influence of asynchronies in different outcomes in in COVID-19 patients under invasive mechanical ventilation
Time frame: Each day from the day of mechanical ventilation initiation until the end of invasive mechanical ventilation, ICU discharge and hospital discharge or up to 28 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 14 Jul 2020.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mechanical Ventilation Complication, run by Corporacion Parc Tauli at 1 site in Spain.
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 3 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 14 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. 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?
Incidence and pattern of presentation of Reverse triggering in COVID-19 patients under invasive mechanical ventilation (time frame: during the 5 first days of invasive mechanical ventilation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Jul 2020.