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Evaluation of the Sede-E protocol in practice: clinical study conducted in multiple hospitals with randomized participants

Clinical evaluation of the use of the Sede-E protocol: multicenter randomized clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-7v3rgrt
Enrollment
Unknown
Registered
2025-08-07
Start date
2025-11-01
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intensive Care Units

Interventions

A four-arm, parallel, multicenter, randomized clinical trial (RCT) will be conducted. The population will consist of two groups of critically ill patients admitted to the ICU: recently extubated patie
N05.715.360.330.125
N02.421.585.190

Sponsors

Universidade Estadual de Londrina
Lead Sponsor
Universidade Estadual de Maringá
Collaborator

Eligibility

Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients admitted to the Intensive Care Unit (ICU); within one hour of extubation; not using non-invasive ventilation at the time of assessment; age 18 or older; both sexes; thirsty

Exclusion criteria

Exclusion criteria: Need for reintubation; post-operative head and neck surgery; dysphagia prior to intubation; and contraindication to elevating the head of the bed by 30 to 45º

Design outcomes

Primary

MeasureTime frame
A reduction in thirst intensity is expected after the intervention, assessed using a Visual Numeric Scale (VNS) from zero to ten—

Secondary

MeasureTime frame
Assess the presence of Defining Characteristics of Perioperative Thirst and adverse events—

Countries

Brazil

Contacts

Public ContactIsabela Faleiros

Universidade Estadual de Londrina

isabela.faleiros@uel.br+55(43)33712908

Outcome results

None listed

Source: REBEC (via WHO ICTRP)