The Use of ExPreS in the Weaning of Patients in Invasive Mechanical Ventilation

NCT05085457 | Completed DMC

• 1 other identifier: RCT ExPreS
• Study Type: interventional
• Target: 540
• Locations: 1 country
• Sites: 1

Brief Summary

Patients on mechanical ventilation (MV) must undergo weaning, an interruption of ventilatory support. Several scores have been developed to predict this outcome, but the failure index in weaning and extubation remains high. The aim of this study is to evaluate the effect of ExPreS - Extubation Predictive Score - on the rate of successful extubation. This research will be conducted in a randomized clinical trial in ICUs of several hospitals. It is expected that there will be a difference between devices for predicting extubation success, and because ExPreS is a protocol that evaluates various parameters related to many organs and systems, it has a better ability to predict extubation success in MV patients.

Conditions

Respiratory Insufficiency

Keywords

Mechanical Ventilation; Extubation; Weaning

Outcome Measures

Primary Outcomes (1)

• Extubation Success

  No reintubation nor dependence of NIV

  48 hours

Secondary Outcomes (5)

• Reintubation

  28 days

• IMV lenght of stay

  28 days

• ICU lenght of stay

  28 days

• Hospital lenght of stay

  28 days

• In Hospital mortality

  28 days

Study Arms (2)

Control Group

NO INTERVENTION

On group I (T-ayre and standard protocol), SBT must begin with the pacient in T-ayre, oxygen support that is proprotional to the fraction of inspired oxygen in invasive mechanical ventilation (IMV), during 30 minutes. If the pacient does not show any sign of SBT failure, the rapid shallow beathing index (RSBI) will be calculated and pacients with RSBI lower than 105 L/min will be extubated, meanwhile pacients with RSBI higher than 105 L/min will return to MV for at least 24 hours until the perfomance of a new SBT.

ExPreS Group

EXPERIMENTAL

On group II (T-ayre and ExPreS protocol), the pacient will be submitted to the SBT with T-ayre, with oxygen support that is proprotional to the fraction of inspired oxygen in IMV, during 30 minutes. If the pacient does not show any sign of SBT failure, ExPreS will be calculated. If punctuation is lower than or equal to 44, it indicates weaning failure and the pacient mjust return to MV for 24 hours at least. Punctuation between 45 and 58 must be evaluated if the pacient presents chronic obstructive pulmonary desease (COPD), obesity or heart desease. In this case, the weaning must be continued if there isn't any risck factors. Punctuation higher than or equal 59 indicates that the pacient can be extubated.

Diagnostic Test: ExPreS Protocol

Interventions

ExPreS Protocol DIAGNOSTIC_TEST

the pacient will be submitted to the SBT with T-ayre, with oxygen support that is proprotional to the fraction of inspired oxygen in IMV, during 30 minutes. If the pacient does not show any sign of SBT failure, ExPreS will be calculated. If punctuation is lower than or equal to 44, it indicates weaning failure and the pacient mjust return to MV for 24 hours at least. Punctuation between 45 and 58 must be evaluated if the pacient presents chronic obstructive pulmonary desease (COPD), obesity or heart desease. In this case, the weaning must be continued if there isn't any risck factors. Punctuation higher than or equal 59 indicates that the pacient can be extubated.

ExPreS Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pacients admitted in ICU that are more than 18 years;
• MV for more than 24 hours;
• Assignature of the free and informed consent form by a family member or responsable adult.

You may not qualify if:

• Death before SBT;
• Tracheostomy;
• Self-extubation;
• Accidental extubation;
• Absence of signature of informed consent.

Sponsors & Collaborators

• Universidade do Oeste de Santa Catarina: lead

Study Sites (1)

Hospital Universitário Santa Terezinha

Joaçaba, Santa Catarina, 89600-000, Brazil

Location

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participant will not know if the ExPreS or just RSBI were calculated before extubation. The SBT will be the same for both groups. Investigator and outcomes assessor will not have access to whole patients' data, just the primary and secundary outcomes to perform the statistical analysis.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Patients will be randomized to receive the intervation of Control group or ExPreS group.

Study Record Dates

• First Submitted: October 7, 2021
• First Posted: October 20, 2021
• Study Start: November 1, 2021
• Primary Completion: December 30, 2024
• Study Completion: December 30, 2024
• Last Updated: November 14, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)