Analysis on the Fatigue and Electromyographic Activation on the Mechanical Ventilation Weaning

NCT07387731 | Completed

• 1 other identifier: UFRGS_FAMED_EMG_D
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate respiratory muscle activation and fatigue during the mechanical ventilation weaning process using surface electromyography (sEMG). Despite various weaning methods, failure rates remain significant, necessitating objective evaluative tools. This randomized crossover clinical trial includes patients intubated for at least 24 hours who meet clinical criteria for a spontaneous breathing test (SBT). Participants will undergo two SBT methods: T-tube and Pressure Support Ventilation (PSV) at 7 cmH2O, each lasting 30 minutes and separated by a 30-minute washout period. Respiratory muscle activity will be quantified by the Root Mean Square (RMS) normalized to maximum inspiratory effort (%RMS), while muscle fatigue will be assessed through the Median Frequency (MF) of the power spectrum. The study seeks to determine which weaning method optimizes respiratory muscle performance and predicts extubation success, defined as 48 hours without ventilatory support.

Conditions

Electromyography; Ventilator Weaning; Critical Illness; Intensive Care

Outcome Measures

Primary Outcomes (2)

• Muscle Activation of Respiratory Muscles

  Muscle activation of the respiratory muscles will be assessed using surface electromyography (sEMG). The raw signal will be processed to calculate the Root Mean Square (RMS), reflecting the magnitude of motor unit recruitment. To minimize inter-individual variability and allow for comparison across the crossover phases, all RMS values will be normalized as a percentage of the maximum inspiratory effort (MIE) recorded during a maximal inspiratory pressure (MIP) maneuver. Measurements will be recorded continuously during each phase of the trial: Baseline, the 1st Spontaneous Breathing Trial (SBT), the Washout period (on initial mechanical ventilation settings), and the 2nd SBT. For statistical analysis, the average value of the final minute of each specific phase will be used to compare the respiratory muscle load between different weaning modes.

  Baseline, 30th minute of 1st Spontaneous Breathing Trial, 30th minute of washout (on initial mechanical ventilation settings), and 30th minute of 2nd Spontaneous Breathing Trial. Final minute of each phase used for analysis.

• Muscle Fatigue of Respiratory Muscles

  Muscle fatigue will be evaluated through power spectrum analysis of the sEMG signal to determine the Median Frequency (MF). The MF is a sensitive physiological marker for detecting the early stages of myoelectric fatigue before clinical failure occurs. A significant downward shift in the MF from the beginning to the end of each study phase will be defined as an indicator of muscle fatigue. The assessment will follow the crossover protocol, collecting data at Baseline, during the 1st SBT, during the Washout period (to ensure return to muscular baseline), and during the 2nd SBT. Although data collection is continuous, the primary analysis will focus on the comparison of the MF values obtained in the final minute of each intervention phase to identify if one weaning strategy induces greater fatigue than the other.

  Baseline, 30th minute of 1st Spontaneous Breathing Trial, 30th minute of washout (on initial mechanical ventilation settings), and 30th minute of 2nd Spontaneous Breathing Trial. Final minute of each phase used for analysis.

Secondary Outcomes (1)

• Clinical Tolerance to Extubation Success Rate within 48 hours

  Patients are monitored continuously from the moment of endotracheal tube removal up to 48 hours post-extubation. Success or failure is definitively recorded at the 48-hour mark.

Study Arms (2)

T tube method

ACTIVE COMPARATOR

Diagnostic Test: Sponteneous breathing test in T-tube

Suport ventilation method

ACTIVE COMPARATOR

Diagnostic Test: Sponteneous breathing test in suport ventilation (PSV)

Interventions

Sponteneous breathing test in suport ventilation (PSV) DIAGNOSTIC_TEST

The intervention used in this study will be the two methods of weaning mechanical ventilation, T-tube and supportive ventilation already described in the arms of the study.

Suport ventilation method

Sponteneous breathing test in T-tube DIAGNOSTIC_TEST

The intervention used in this study will be the two methods of weaning mechanical ventilation, T-tube and supportive ventilation already described in the arms of the study.

T tube method

Eligibility Criteria

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

You may qualify if:

• Patients will be intubated and ventilated mechanically for at least 24 hours, capable of starting the spontaneous breathing test based on the criteria recommended by the current Brazilian Recommendations on Mechanical Ventilation (Barbas, 2013), through a decision of the multiprofessional team. They should present adequate level of awareness to understand guidelines and age\> 18 years.

You may not qualify if:

• Patients with psychomotor agitation will not be able to interpret the electromyographic data, requiring an inspired fraction of oxygen greater than 0.6, tracheostomized, peritoniostomies and thoracotomies that would not allow the electrodes to be positioned in the right pectoralis major muscle, laparotomies that would not allow the positioning of the Electrodes in the rectus abdominis muscle and those whose family members have not adhered to the informed consent form (Appendix A).

Sponsors & Collaborators

• Federal University of Rio Grande do Sul: lead

Study Sites (1)

Universidade Federal do Rio Grande do Sul

Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

Location

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Diogo Fanfa Bordin, Master

  Federal University of Rio Grande do Sul

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Randomization, filtering of electromyographic data and statistical analysis will be performed by blind investigators.
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: The binary randomization of the groups will be carried out through the electronic application Bracket RTSM (version 2.0.0, Global Bracket), and will be performed by a blind researcher to the groups evaluated. After evaluation of the eligibility criteria, the selected patients will be randomized into two groups: PSV Group (PSV) and T-tube group (TT), and will be cross-analyzed, with interval time between 30 minutes evaluations, the patient remaining In VM mode during this period.

Study Record Dates

• First Submitted: May 7, 2017
• First Posted: February 4, 2026
• Study Start: April 1, 2017
• Primary Completion: December 1, 2018
• Study Completion: March 13, 2026
• Last Updated: March 17, 2026

Record last verified: 2026-03

Locations

BR (1)