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

NCT06208592 | Completed

• 1 other identifier: 2020-01-Anaconda
• Study Type: observational
• Target: 43
• Locations: 1 country
• Sites: 1

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%.

Conditions

COVID-19; Respiratory Failure

Keywords

sedatives; acute kidney injury; SARS-CoV-2; mechanical ventilation

Outcome Measures

Primary Outcomes (1)

• Intravenous sedation requirements

  Amount of intravenous sedation required

  7 days

Secondary Outcomes (3)

• Delirium

  Hospital stay (up to 30 days)

• Acute kidney injury

  Hospital stay (up to 30 days)

• VAP

  Hospital stay (up to 30 days)

Study Arms (2)

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

Non-Anaconda Group

Use on conventional intravenous sedation, not using Anaconda device

Interventions

Sevoflurane with AnaConDa DEVICE

Sevoflurane administered with AnaConDa device

Anaconda Group

Eligibility Criteria

• Age: 27 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• Tranfers to a different hospital.
• Death within the first 24 hours of hospital stay.

Sponsors & Collaborators

• Hospital Español de Mexico: lead
• Universidad Nacional Autonoma de Mexico: collaborator

Study Sites (1)

Hospital H+ Queretaro

Querétaro City, Querétaro, 76000, Mexico

Location

MeSH Terms

Conditions

COVID-19; Respiratory Insufficiency; Acute Kidney Injury

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Manuel Lomeli, MD

  Hospital H+ Queretaro

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 7 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: January 15, 2024
• First Posted: January 17, 2024
• Study Start: May 30, 2020
• Primary Completion: September 18, 2020
• Study Completion: November 6, 2020
• Last Updated: January 26, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Available one year after
• Access Criteria: Journal provided

Locations

ME (1)