Acute Mechanical Ventilatory FailureNCT02743624
Criteria Analysis for Ventilatory Support Adjustment of Mechanical Ventilation
A study testing Variation of the level of pressure support during the mechanical ventilation in people with Acute Mechanical Ventilatory Failure, run by University of Sao Paulo General Hospital at 2 sites in Brazil.
Trial summary
The indications for mechanical ventilation (MV) include excessive work of breathing, with or without evidence of respiratory muscle fatigue. The setting of the MV is still a challenge because it is based on criteria understudied, often subjective and observer-dependent. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Acute Mechanical Ventilatory Failure
- What is being tested?
- Variation of the level of pressure support during the mechanical ventilation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 2 sitesBrazil
- Study dates
- Feb 2016to Dec 2016
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients under invasive mechanical ventilation for 48h
- patients without the objective of complete rest of the respiratory muscles. This decision will be on the discretion of the attending physician,
- spontaneous breathing,
- clinically stability.
Who cannot join
- Previous disease of the central nervous system that can lead to respiratory changes.
- Previous disease of the peripheral nervous system that can lead to respiratory changes
- Previous muscular disease.
Trial locations and contacts
2 sites in 1 country.
Brazil2 sites
Hospital Clinicas Sao Paulo
São Paulo, São Paulo, 05403-000
Hearth Institute - University of Sao Paulo
São Paulo, São Paulo, 05403900
About this study
The indications for mechanical ventilation (MV) include excessive work of breathing, with or without evidence of respiratory muscle fatigue. The setting of the MV is still a challenge because it is based on criteria understudied, often subjective and observer-dependent. Despite several studies, to our knowledge has never been done before is the precise definition of the optimal range of ventilatory support. Novel and recognizable diagnostic techniques will be applied. No single parameter of the breathing pattern has good accuracy for the adjustment of ventilatory support. Non-invasive measures such as P0.1 and rate of muscle relaxation may have good accuracy for the adjustment of ventilatory support.
Read the detailed description
Use of excessive pressure support
- Conditions
- Acute Mechanical Ventilatory Failure
- Being tested
- Variation of the level of pressure support during the mechanical ventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Variation of the level of pressure support during the mechanical ventilationProcedure or surgery
The pressure support of the patient was changed form the baseline to 20 cmH20 and then stepwise decreased to 2 cmH20,
| Study group | Role | What they receive |
|---|---|---|
| Pressure Support Titration | Other | The analysis of the diagnostic accuracy of the breathing pattern variables, P 0.1 and the rate of tracheal muscle relaxation. Receives: Procedure: Variation of the level of pressure support during the mechanical ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measuring muscular force
Muscular force measured by inspiratory force in centimeters of water (cmH2O)
Measured: From the baseline ventilation to the minimum level of pressure support. Around 3 hours
Secondary outcomes (2)
Measuring inspiratory drive
Inspiratory drive measured in cmH2O in the first 100 milliseconds of the inspiration
Measured: From the baseline ventilation to the minimum level of pressure support. Around 3 hours
Measuring endurance
Endurance measured by the maximal relaxation rate (cmH2O/10ms)
Measured: From the baseline ventilation to the minimum level of pressure support. Around 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2016 (estimated)
- Study startFeb 2016
- Primary completionNov 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Mechanical Ventilatory FailureStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe sponsor's other registered studies.
- 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carlos Carvalho, Study director, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02743624
- Sponsor's protocol ID
- tematicomusculoUTI
- Status last verified
- Aug 2016
- First submitted
- 18 Mar 2016
- Last updated
- 19 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Criteria Analysis for Ventilatory Support Adjustment of Mechanical Ventilation
- ClinicalTrials.gov ID
- NCT02743624
- Acronym / sponsor ID
- tematicomusculoUTI
- Conditions
- Acute Mechanical Ventilatory Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- Nov 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 19 Apr 2016 (estimated)
- 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.
The indications for mechanical ventilation (MV) include excessive work of breathing, with or without evidence of respiratory muscle fatigue. The setting of the MV is still a challenge because it is based on criteria understudied, often subjective and observer-dependent. Despite several studies, to our knowledge has never been done before is the precise definition of the optimal range of ventilatory support. Novel and recognizable diagnostic techniques will be applied. No single parameter of the breathing pattern has good accuracy for the adjustment of ventilatory support. Non-invasive measures such as P0.1 and rate of muscle relaxation may have good accuracy for the adjustment of ventilatory support.
Detailed description
Use of excessive pressure support
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pressure Support Titration | Other | Procedure: Variation of the level of pressure support during the mechanical ventilationThe analysis of the diagnostic accuracy of the breathing pattern variables, P 0.1 and the rate of tracheal muscle relaxation. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- patients under invasive mechanical ventilation for 48h
- patients without the objective of complete rest of the respiratory muscles. This decision will be on the discretion of the attending physician,
- spontaneous breathing,
- clinically stability.
Key exclusion criteria (3 listed)
- Previous disease of the central nervous system that can lead to respiratory changes.
- Previous disease of the peripheral nervous system that can lead to respiratory changes
- Previous muscular disease.
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 |
|---|---|---|
| Variation of the level of pressure support during the mechanical ventilationThe pressure support of the patient was changed form the baseline to 20 cmH20 and then stepwise decreased to 2 cmH20, | Procedure or surgery | Pressure Support Titration |
Primary outcome
Measuring muscular force
Time frame: From the baseline ventilation to the minimum level of pressure support. Around 3 hours
Muscular force measured by inspiratory force in centimeters of water (cmH2O)
2 secondary outcomes
Measuring inspiratory drive
Time frame: From the baseline ventilation to the minimum level of pressure support. Around 3 hours
Measuring endurance
Time frame: From the baseline ventilation to the minimum level of pressure support. Around 3 hours
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 19 Jan 2017.
- Individual participant dataSharing planned: No
Related trials for Acute Mechanical Ventilatory Failure
Recruiting
Medical Device Clinical Trial Without CE Marking to Evidence Safety and Performance of the INBENTUS VERSATILE Ventilator in Patients Requiring Assisted/Controlled Mechanical Ventilation and Weaning.
Acute Respiratory Distress Syndrome (ARDS), Pneumonia
Recruiting
Targeting prEssure-Muscle-index to Avoid Ventilatory Over-Assistance During Pressure Support Ventilation
Acute Hypoxemic Respiratory Failure, Mechanical Ventilation Complication
Not yet recruiting
Evaluation of the Clinical and Prognostic Value of Non-invasive Analysis of Mandibular Movements (MM) as a Marker of Inspiratory Effort in the Spontaneously Breathing Intensive Care Patient
Acute Respiratory Failure (ARF), Intensive Care Unit (ICU) Patients
Active, not recruitingObservational study
Assessment of PaO2/FiO2 Ratio Pre and POst INTubation
Acute Hypoxemic Respiratory Failure
Recruiting
The Effects of Music Therapy on Adult Patients Requiring Mechanical Ventilation in the ICU
Acute Respiratory Distress Syndrome, Acute Hypoxemic Respiratory Failure
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.
Carlos Carvalho study director
University of Sao Paulo
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Variation of the level of pressure support during the mechanical ventilation in people with Acute Mechanical Ventilatory Failure, run by University of Sao Paulo General Hospital at 2 sites 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 4 inclusion and 3 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 19 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Measuring muscular force (time frame: From the baseline ventilation to the minimum level of pressure support. Around 3 hours). 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 19 Jan 2017.