Comparative Study of Anaconda System Use Versus Conventional Sedation in COVID-19 Patients.

COVID-19 Clinical Trial

Official title:

Comparative Study of Sedative Requirement Using Sevoflurane With Anaconda Device Versus Conventional Sedation in Patients With COVID-19

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06208592
• Other study ID #: 2020-01-Anaconda
• Status: Completed
• Start date: May 30, 2020
• Est. completion date: November 6, 2020

Study information

• Verified date: January 2024
• Source: Hospital Español de Mexico
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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 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%.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: November 6, 2020
• Est. primary completion date: September 18, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 27 Years to 85 Years

Eligibility

Inclusion Criteria:

• Adult patients with confirmed COVI-19 infection and assited with mechanical ventilation who entered critical care department.

Exclusion Criteria:

• Tranfers to a different hospital.

• Death within the first 24 hours of hospital stay.

Related Conditions & MeSH terms

• COVID-19
• Respiratory Failure
• Respiratory Insufficiency

Intervention

Device:
• Sevoflurane with AnaConDa
Sevoflurane administered with AnaConDa device

Locations

Country	Name	City	State
Mexico	Hospital H+ Queretaro	Querétaro City	Querétaro

Sponsors (2)

Lead Sponsor	Collaborator
Hospital Español de Mexico	Universidad Nacional Autonoma de Mexico

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intravenous sedation requirements	Amount of intravenous sedation required	7 days
Secondary	Delirium	Number of patients that suffered delirium	Hospital stay (up to 30 days)
Secondary	Acute kidney injury	Number of patients that suffered delirium	Hospital stay (up to 30 days)
Secondary	VAP	Number of patients that suffered ventilation acquired pneumonia	Hospital stay (up to 30 days)