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

Completed

• Conditions: Respiratory Failure; COVID-19
• Interventions: Device: Sevoflurane with AnaConDa

• Registration Number: NCT06208592
• Lead Sponsor: Hospital Español de Mexico

Brief 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%.

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 Timeline

• Study Start: 2020-05-30
• Primary Completion: 2020-09-18
• Study Completion: 2020-11-06
• Status Verified: 2024-01
• Study First Submitted: 2024-01-15
• Study First Submitted QC: 2024-01-15
• Study First Posted: 2024-01-17
• Last Update Submitted: 2024-01-24
• Last Update Posted: 2024-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Anaconda Group	Sevoflurane with AnaConDa	Use of Anaconda devide at any point during the initial follow up (7 days) additional of conventional intravenous sedation

Primary Outcome Measures

Name	Time	Method
Intravenous sedation requirements	7 days	Amount of intravenous sedation required

Secondary Outcome Measures

Name	Time	Method
Acute kidney injury	Hospital stay (up to 30 days)	Number of patients that suffered delirium
VAP	Hospital stay (up to 30 days)	Number of patients that suffered ventilation acquired pneumonia
Delirium	Hospital stay (up to 30 days)	Number of patients that suffered delirium

Trial Locations

Locations (1)

Hospital H+ Queretaro; 🇲🇽 Querétaro City, Querétaro, Mexico