COVID-19NCT06208592
Comparative Study of Anaconda System Use Versus Conventional Sedation in COVID-19 Patients.
An observational study of COVID-19 and Respiratory Failure, run by Hospital Español de Mexico at 1 site in Mexico.
Trial summary
At the beginning of 2020, a global alert emerged which saturated intensive care units due to COVID-19 worldwide. This caused a need for mechanical ventilation due to atypical pneumonias that had a rapid evolution and respiratory failure; therefore the consumption of sedative agents in the intensive care units… Read more about this study
- Who is it for?
- Ages 27 to 85 years
- Conditions the study is for
- COVID-19, Respiratory Failure
- What is being tested?
- Sevoflurane with AnaConDa
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 43 participants
- Where
- 1 siteMexico
- Study dates
- 30 May 2020to 6 Nov 2020
- How long will I take part?
- 7 Months
- 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 27 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with confired COVID-19 infection assited with mechanical ventilation that required sedation.
Who may be able to join
- Adult patients with confirmed COVI-19 infection and assited with mechanical ventilation who entered critical care department.
Who cannot join
- Tranfers to a different hospital.
- Death within the first 24 hours of hospital stay.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Study of Sedative Requirement Using Sevoflurane With Anaconda Device Versus Conventional Sedation in Patients With COVID-19
At the beginning of 2020, a global alert emerged which saturated intensive care units due to COVID-19 worldwide. This caused a need for mechanical ventilation due to atypical pneumonias that had a rapid evolution and respiratory failure; therefore the consumption of sedative agents in the intensive care units escalated. Suboptimal sedation in the intensive care unit, increases the adverse effects, costs, and morbidity. For the time being, they focus on the use of intravenous agents such as propofol or dexmedetomidine, which are associated with tolerance, withdrawal, delirium, and hemodynamic effects. Consequently, the need arises to maximize availability and effectiveness, which is why the intervention of the ANACONDA conservation device is carried out, which works with a heat and humidity exchange filter capable of administering isoflurane or sevoflurane with an efficiency of 90%.
Read the detailed description
Analyze the difference in intravenous sedation requirements in patients with COVID-19. Patients who were assisted by a mechanical ventilator with sevoflurane versus conventional sedation.
- Conditions
- COVID-19, Respiratory Failure
- Being tested
- Sevoflurane with AnaConDa
- Keywords
- sedatives, acute kidney injury, SARS-CoV-2, mechanical ventilation
- Medical subject headings
- COVID-19, Respiratory Insufficiency, Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sevoflurane with AnaConDaDevice
Sevoflurane administered with AnaConDa device
| Study group | Role | What they receive |
|---|---|---|
| Anaconda Group | Use of Anaconda devide at any point during the initial follow up (7 days) additional of conventional intravenous sedation Receives: Device: Sevoflurane with AnaConDa | |
| Non-Anaconda Group | Use on conventional intravenous sedation, not using Anaconda device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intravenous sedation requirements
Amount of intravenous sedation required
Measured: 7 days
Secondary outcomes (3)
Delirium
Number of patients that suffered delirium
Measured: Hospital stay (up to 30 days)
Acute kidney injury
Number of patients that suffered delirium
Measured: Hospital stay (up to 30 days)
VAP
Number of patients that suffered ventilation acquired pneumonia
Measured: Hospital stay (up to 30 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2024
- Study start30 May 2020
- Primary completion18 Sep 2020
- Study completion6 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies 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
- 43 participants (actual)
- Target duration
- 7 Months
Sponsor and investigators
- Lead sponsor
- Hospital Español de Mexico
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad Nacional Autonoma de Mexico
- Responsible party
- Principal investigator, Jose J Zaragoza, MD, Hospital H+ Queretaro
- Investigators
- Manuel Lomeli, MD, Study chair, Hospital H+ Queretaro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06208592
- Sponsor's protocol ID
- 2020-01-Anaconda
- Status last verified
- Jan 2024
- First submitted
- 15 Jan 2024
- Last updated
- 26 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Complete database will be shared as requested by the publishing journal, once the study is apporved.
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of Sedative Requirement Using Sevoflurane With Anaconda Device Versus Conventional Sedation in Patients With COVID-19
- ClinicalTrials.gov ID
- NCT06208592
- Acronym / sponsor ID
- 2020-01-Anaconda
- Conditions
- COVID-19, Respiratory Failure
- Keywords
- sedatives, acute kidney injury, SARS-CoV-2, mechanical ventilation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Hospital Español de MexicoUniversity, hospital or other
- Collaborators
- Universidad Nacional Autonoma de Mexico
- Study start
- 30 May 2020 (actual)
- Primary completion
- 18 Sep 2020 (actual)
- Study completion
- 6 Nov 2020 (actual)
- First posted
- 17 Jan 2024 (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.
At the beginning of 2020, a global alert emerged which saturated intensive care units due to COVID-19 worldwide. This caused a need for mechanical ventilation due to atypical pneumonias that had a rapid evolution and respiratory failure; therefore the consumption of sedative agents in the intensive care units escalated. Suboptimal sedation in the intensive care unit, increases the adverse effects, costs, and morbidity. For the time being, they focus on the use of intravenous agents such as propofol or dexmedetomidine, which are associated with tolerance, withdrawal, delirium, and hemodynamic effects. Consequently, the need arises to maximize availability and effectiveness, which is why the intervention of the ANACONDA conservation device is carried out, which works with a heat and humidity exchange filter capable of administering isoflurane or sevoflurane with an efficiency of 90%.
Detailed description
Analyze the difference in intravenous sedation requirements in patients with COVID-19. Patients who were assisted by a mechanical ventilator with sevoflurane versus conventional sedation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 7 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anaconda Group | – | Device: Sevoflurane with AnaConDaUse of Anaconda devide at any point during the initial follow up (7 days) additional of conventional intravenous sedation |
| Non-Anaconda Group | – | –Use on conventional intravenous sedation, not using Anaconda device |
Who may qualify
- Ages
- 27 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with confired COVID-19 infection assited with mechanical ventilation that required sedation.
Key inclusion criteria (1 listed)
- Adult patients with confirmed COVI-19 infection and assited with mechanical ventilation who entered critical care department.
Key exclusion criteria (2 listed)
- Tranfers to a different hospital.
- Death within the first 24 hours of hospital stay.
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 |
|---|---|---|
| Sevoflurane with AnaConDaSevoflurane administered with AnaConDa device | Device | Anaconda Group |
Primary outcome
Intravenous sedation requirements
Time frame: 7 days
Amount of intravenous sedation required
3 secondary outcomes
Delirium
Time frame: Hospital stay (up to 30 days)
Acute kidney injury
Time frame: Hospital stay (up to 30 days)
VAP
Time frame: Hospital stay (up to 30 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 26 Jan 2024.
- Individual participant dataSharing planned: Yes. Complete database will be shared as requested by the publishing journal, once the study is apporved.
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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.
Manuel Lomeli, MD study chair
Hospital H+ Queretaro
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 COVID-19 and Respiratory Failure, run by Hospital Español de Mexico at 1 site in Mexico.
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 1 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 26 Jan 2024. 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 Mexico. 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?
Intravenous sedation requirements (time frame: 7 days). 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 26 Jan 2024.