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

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%.

Study Overview

• Status: Completed
• Conditions: COVID-19; Respiratory Failure
• Intervention / Treatment: Device: Sevoflurane with AnaConDa

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 Type: Observational
• Enrollment (Actual): 43

Contacts and Locations

Study Locations

• Mexico
  • Querétaro
    • Querétaro City, Querétaro, Mexico, 76000
      • Hospital H+ Queretaro

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with confired COVID-19 infection assited with mechanical ventilation that required sedation.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Anaconda Group; Use of Anaconda devide at any point during the initial follow up (7 days) additional of conventional intravenous sedation	Device: Sevoflurane with AnaConDa; Sevoflurane administered with AnaConDa device
Non-Anaconda Group; Use on conventional intravenous sedation, not using Anaconda device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intravenous sedation requirements	Amount of intravenous sedation required	7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Delirium	Number of patients that suffered delirium	Hospital stay (up to 30 days)
Acute kidney injury	Number of patients that suffered delirium	Hospital stay (up to 30 days)
VAP	Number of patients that suffered ventilation acquired pneumonia	Hospital stay (up to 30 days)

Collaborators and Investigators

• Sponsor: Hospital Español de Mexico
• Collaborators: Universidad Nacional Autonoma de Mexico
• Investigators: Study Chair: Manuel Lomeli, MD, Hospital H+ Queretaro

Study record dates

Study Major Dates

• Study Start (Actual): May 30, 2020
• Primary Completion (Actual): September 18, 2020
• Study Completion (Actual): November 6, 2020

Study Registration Dates

• First Submitted: January 15, 2024
• First Submitted That Met QC Criteria: January 15, 2024
• First Posted (Actual): January 17, 2024

Study Record Updates

• Last Update Posted (Actual): January 26, 2024
• Last Update Submitted That Met QC Criteria: January 24, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: SARS-CoV-2; mechanical ventilation; acute kidney injury; sedatives
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Respiration Disorders; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Respiratory Insufficiency; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics, General; Anesthetics; Platelet Aggregation Inhibitors; Anesthetics, Inhalation; Sevoflurane
• Other Study ID Numbers: 2020-01-Anaconda

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Complete database will be shared as requested by the publishing journal, once the study is apporved.
• IPD Sharing Time Frame: Available one year after
• IPD Sharing Access Criteria: Journal provided
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes