ElectromyographyAFAEMGNCT07387731
Analysis on the Fatigue and Electromyographic Activation on the Mechanical Ventilation Weaning
A study testing Sponteneous breathing test in T-tube and Sponteneous breathing test in suport ventilation (PSV) in people with Electromyography and Ventilator Weaning, run by Federal University of Rio Grande do Sul at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Electromyography, Ventilator Weaning, Critical Illness
- What is being tested?
- Sponteneous breathing test in T-tube and Sponteneous breathing test in suport ventilation (PSV)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Apr 2017to 13 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- -
Who cannot join
- 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).
- -
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Universidade Federal do Rio Grande do Sul
Porto Alegre, Rio Grande do Sul, 90035-903
About this study
Official title: Study of Fatigue and Respiratory Muscle Activation in the Spontaneous Breathing Test in Tube t Versus Support Ventilation at Mechanical Ventilation Weaning: Randomized Clinical Trial
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.
Read the detailed description
This randomized crossover clinical trial aims to compare the physiological effects of two spontaneous breathing trial (SBT) methods on respiratory muscle activity and fatigue in patients undergoing mechanical ventilation weaning. Patients intubated for at least 24 hours who meet clinical stability criteria-including adequate level of consciousness (Glasgow Coma Scale ≥ 13), hemodynamic stability without high doses of vasopressors, and an inspired oxygen fraction (FiO2) ≤ 0.4 - will be eligible for the study. Upon inclusion, participants will be randomized to one of two sequences: T-piece followed by Pressure Support Ventilation (PSV), or PSV followed by T-piece. The T-piece SBT involves disconnection from the ventilator with supplemental oxygen, while the PSV SBT is performed at 7 cmH2O with PEEP between 5-8 cmH2O. Each trial lasts 30 minutes, separated by a 30-minute washout period during which the patient is returned to their initial baseline ventilator settings to ensure physiological recovery and prevent carry-over effects. Electromyographic (sEMG) data will be captured using surface electrodes placed on the external intercostal muscles following SENIAM guidelines. Signal processing includes a Butterworth band-pass filter (20-450 Hz) and a sampling rate of at least 1000 Hz. The Root Mean Square (RMS) will be used to quantify muscle activation, normalized against the maximum inspiratory effort (%RMS) obtained during maximal inspiratory pressure (MIP) maneuvers. Muscle fatigue will be analyzed through the Median Frequency (MF) of the power spectrum using Fast Fourier Transform (FFT). Following the SBTs, patients will be extubated and monitored for 48 hours to determine the extubation success rate, defined as the absence of reintubation or rescue ventilatory support.Sample Size Calculation: The sample size was calculated based on the first five individuals evaluated, considering the mean and standard deviation of the primary outcome (%RMS) between the two evaluated methods. Adopting a significance level of 5% (a [alpha] = 0.05) and a statistical power of 80% (b [beta] = 0.80), the calculation indicated a required sample of [insira aqui o número total de pacientes, ex: 19] participants. To account for possible sample losses or technical signal artifacts, an additional 10% was added to the total.Statistical Analysis: Data distribution will be assessed using the Shapiro-Wilk test. Continuous variables will be expressed as mean and standard deviation or median and interquartile range, depending on normality. To compare the %RMS and MF between the T-piece and PSV methods, a Paired T-test or Wilcoxon Signed-Rank test will be utilized. For the analysis of time points (Baseline vs. 30th minute), a Two-way ANOVA for repeated measures with Post-hoc Bonferroni will be applied to identify significant differences and potential interaction effects between the weaning method and time. Categorical data, such as extubation success rate, will be analyzed using the Chi-square test or Fisher's Exact test. A p-value < 0.05 will be considered statistically significant for all analyses, which will be performed using SPSS software.
- Conditions
- Electromyography, Ventilator Weaning, Critical Illness, Intensive Care
- Being tested
- Sponteneous breathing test in T-tube, Sponteneous breathing test in suport ventilation (PSV)
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sponteneous breathing test in T-tubeDiagnostic 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.
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.
| Study group | Role | What they receive |
|---|---|---|
| T tube method | Active comparator | Not described Receives: Diagnostic Test: Sponteneous breathing test in T-tube |
| Suport ventilation method | Active comparator | Not described Receives: Diagnostic Test: Sponteneous breathing test in suport ventilation (PSV) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Extubation success is defined as the patient's ability to maintain spontaneous breathing for a minimum of 48 hours following the removal of the endotracheal tube, without the need for reintubation or any form of rescue ventilatory support, including non-invasive ventilation (NIV). Clinical tolerance is monitored through standard weaning criteria, including a respiratory rate below 35 breaths per minute, oxygen saturation above 90% on FiO2 ≤ 40%, heart rate within 20% of baseline, and the absence of signs of increased respiratory work, such as accessory muscle use or paradoxical abdominal movement. The occurrence of reintubation or the necessity for ventilatory assistance within this 48-hour window is classified as extubation failure.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2026
- Study start1 Apr 2017
- Primary completion1 Dec 2018
- Study completion13 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ElectromyographyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Rio Grande do Sul
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Diogo Fanfa Bordin, Federal University of Rio Grande do Sul
- Investigators
- Diogo Fanfa Bordin, Master, Study chair, Federal University of Rio Grande do Sul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07387731
- Sponsor's protocol ID
- UFRGS_FAMED_EMG_D
- Acronym
- AFAEMG
- Status last verified
- Mar 2026
- First submitted
- 7 May 2017
- Last updated
- 17 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Fatigue and Respiratory Muscle Activation in the Spontaneous Breathing Test in Tube t Versus Support Ventilation at Mechanical Ventilation Weaning: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07387731
- Acronym / sponsor ID
- AFAEMG / UFRGS_FAMED_EMG_D
- Conditions
- Electromyography, Ventilator Weaning, Critical Illness, Intensive Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Federal University of Rio Grande do SulUniversity, hospital or other
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 1 Dec 2018 (actual)
- Study completion
- 13 Mar 2026 (actual)
- First posted
- 4 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This randomized crossover clinical trial aims to compare the physiological effects of two spontaneous breathing trial (SBT) methods on respiratory muscle activity and fatigue in patients undergoing mechanical ventilation weaning. Patients intubated for at least 24 hours who meet clinical stability criteria-including adequate level of consciousness (Glasgow Coma Scale ≥ 13), hemodynamic stability without high doses of vasopressors, and an inspired oxygen fraction (FiO2) ≤ 0.4 - will be eligible for the study. Upon inclusion, participants will be randomized to one of two sequences: T-piece followed by Pressure Support Ventilation (PSV), or PSV followed by T-piece. The T-piece SBT involves disconnection from the ventilator with supplemental oxygen, while the PSV SBT is performed at 7 cmH2O with PEEP between 5-8 cmH2O. Each trial lasts 30 minutes, separated by a 30-minute washout period during which the patient is returned to their initial baseline ventilator settings to ensure physiological recovery and prevent carry-over effects. Electromyographic (sEMG) data will be captured using surface electrodes placed on the external intercostal muscles following SENIAM guidelines. Signal processing includes a Butterworth band-pass filter (20-450 Hz) and a sampling rate of at least 1000 Hz. The Root Mean Square (RMS) will be used to quantify muscle activation, normalized against the maximum inspiratory effort (%RMS) obtained during maximal inspiratory pressure (MIP) maneuvers. Muscle fatigue will be analyzed through the Median Frequency (MF) of the power spectrum using Fast Fourier Transform (FFT). Following the SBTs, patients will be extubated and monitored for 48 hours to determine the extubation success rate, defined as the absence of reintubation or rescue ventilatory support.Sample Size Calculation: The sample size was calculated based on the first five individuals evaluated, considering the mean and standard deviation of the primary outcome (%RMS) between the two evaluated methods. Adopting a significance level of 5% (a [alpha] = 0.05) and a statistical power of 80% (b [beta] = 0.80), the calculation indicated a required sample of [insira aqui o número total de pacientes, ex: 19] participants. To account for possible sample losses or technical signal artifacts, an additional 10% was added to the total.Statistical Analysis: Data distribution will be assessed using the Shapiro-Wilk test. Continuous variables will be expressed as mean and standard deviation or median and interquartile range, depending on normality. To compare the %RMS and MF between the T-piece and PSV methods, a Paired T-test or Wilcoxon Signed-Rank test will be utilized. For the analysis of time points (Baseline vs. 30th minute), a Two-way ANOVA for repeated measures with Post-hoc Bonferroni will be applied to identify significant differences and potential interaction effects between the weaning method and time. Categorical data, such as extubation success rate, will be analyzed using the Chi-square test or Fisher's Exact test. A p-value < 0.05 will be considered statistically significant for all analyses, which will be performed using SPSS software.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
- -
Key exclusion criteria (2 listed)
- 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).
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sponteneous breathing test in T-tubeThe 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. | Diagnostic test | T tube method |
| Sponteneous breathing test in suport ventilation (PSV)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. | Diagnostic test | Suport ventilation method |
Primary outcome
Muscle Activation of Respiratory Muscles
Time frame: 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 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.
Muscle Fatigue of Respiratory Muscles
Time frame: 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 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.
1 secondary outcome
Clinical Tolerance to Extubation Success Rate within 48 hours
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Diogo Fanfa Bordin, Master study chair
Federal University of Rio Grande do Sul
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sponteneous breathing test in T-tube and Sponteneous breathing test in suport ventilation (PSV) in people with Electromyography and Ventilator Weaning, run by Federal University of Rio Grande do Sul at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle Activation of Respiratory Muscles (time frame: 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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2026.