SepsisPhase 1/2NCT02367170
Project 4A: Inspiratory Muscle Training and Diaphragm Strength
A Phase 1/2 study testing Bilateral phrenic nerve stimulation and measurement of transdiaphragmatic pressure, Midazolam and Volitional Measurement of Maximal Inspiratory Pressure (MIP) in people with Sepsis, run by University of Florida at 1 site in United States.
Trial summary
Investigators will assess the effect of exercise on markers of inflammation and protein catabolism. This research study will further our understanding of how treating Chronic Critical illness (CCI) - related respiratory muscle weakness with strength training can not only improve muscle function, but also potentially… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis
- What is being tested?
- Bilateral phrenic nerve stimulation and measurement of transdiaphragmatic pressure, Midazolam and Volitional Measurement of Maximal Inspiratory Pressure (MIP)
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2015to Jul 2015
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- presence in the surgical or trauma ICU
- age of ≥18 years
- received mechanical ventilation (MV) for 3 days and expected to survive ICU stay
- ability to obtain informed consent from patient or proxy
Who cannot join
- Inability to speak and understand English
- Uncontrollable source of sepsis with imminent death (e.g., irreversible disease state, unresectable dead bowel)
- Receiving "comfort care only" or have advanced care directives limiting resuscitative efforts
- Known HIV infection with CD4 count < 200 cells/mm
- Organ transplant recipients on immunosuppressive agent(s),
- Known pregnancy
Show all 22Show fewer
- Unable to follow simple, one-step commands, such as "breathe in as hard as you can!"
- Prior arrangements to be transferred to other facilities before 28 days of treatment
- Contraindications to being disconnected from MV for sham or inspiratory muscle strength training treatment
- Unstable or "difficult airway" at 3 days of ICU care defined by ICU protocol, predicted to last for more than 72 hours
- Ongoing use of vasopressor or vasodilatatory agents for unstable blood pressure. (beyond minimal intermittent amount or "renal perfusion dose,"
- Severe cardiac dysrhythmias
- Esophageal varices or recent esophageal or gastric surgery,
- Upper-airway issues that would be aggravated by inserting esophageal pressure transducers
- Unstable neck/cervical anatomy that might be adversely impacted by bilateral magnetic stimulation of phrenic nerves at the neck
- Acute coronary syndrome
- Pulmonary contraindications (pneumon/hemothorax not drained, flail chest)
- Cardiac pacemakers and/or implanted defibrillator or other implanted electronic devices interfering with magnetic stimulation
- Implanted metal in the chest, neck or head, making magnetic stimulation contraindicated (dental fillings are permitted)
- Postoperative severe surgical problems interfering with the respiratory training (serious postoperative bleeding, wound dehiscence, etc.) - when and if these problems resolve and the patient meets other entry criteria, they will be eligible to be recruited for participation
- Active neuromuscular diseases that would prevent or interfere with responding to strength training (e.g. amyotrophic lateral sclerosis, multiple sclerosis, myasthenia gravis, polymyositis, muscular dystrophy or other dystrophies and myopathies)
- Any other factor that in the investigators' opinions would prevent response to training or create an unsafe condition for the patient.
Trial locations and contacts
1 site in 1 country.
United States1 site
UF Health Shands Hospital at the University of Florida
Gainesville, Florida, 32610
About this study
Official title: Study: Persistent Inflammation, Immunosuppression and Catabolism Syndrome (PICS): A New Horizon for Surgical Critical Care: Project 4A: Inspiratory Muscle Training and Diaphragm Strength
Investigators will assess the effect of exercise on markers of inflammation and protein catabolism. This research study will further our understanding of how treating Chronic Critical illness (CCI) - related respiratory muscle weakness with strength training can not only improve muscle function, but also potentially blunt the inflammation and catabolism of Peristent Inflammation/Immunosuppression and Catabolism (PICS).
Read the detailed description
In this research study, investigators will assign study participants to two groups: high intensity inspiratory muscle training and low intensity inspiratory muscle training group. This research study will last up to 28 days in 24 mechanically ventilated patients with CCI. The goal is to determine if the research participants can respond to a training program by improving weaning outcomes from the ventilator. This will be determined by measurement of breathing muscle strength with magnetic stimulation, measurement of diaphragm thickness with ultrasound, inspiratory muscle training, and blood and urine samples.
- Conditions
- Sepsis
- Being tested
- Bilateral phrenic nerve stimulation and measurement of transdiaphragmatic pressure, Midazolam, Volitional Measurement of Maximal Inspiratory Pressure (MIP), Inspiratory Muscle Strength Training (IMST), SHAM Inspiratory Muscle Strength Training (IMST)
- Keywords
- respiratory dysfunction, chronic critical illness, diaphragm weakness, sepsis, ventilator dependance
- Medical subject headings
- Sepsis, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bilateral phrenic nerve stimulation and measurement of transdiaphragmatic pressureProcedure or surgery
Pressure changes are recorded. The phrenic nerves are stimulated with bilateral magnetic stimulators over the neck. Measurements will be performed on day 1, every 7 days after and on last day of participation. The FiO2 will be increased (at least 20%) for at least 2 min. prior to measurement to maintain oxygen saturation >92%. Prior to activating the stimulator, the artificial airway will be occluded with a pneumatic valve to create a quasi-isometric diaphragm contraction. The airway will be occluded for 3 seconds or less for each stimulation. The procedure will be repeated up to a maximum of 5 times per testing day.
MidazolamDrug
Also called Versed
In the event a subject shows signs of distress during the Bilateral phrenic nerve stimulation and measurement of transdiaphragmatic pressures, a dose of Midazolam is available. IV (in the vein) dose from 0.5 mg to 2 mg.
Volitional Measurement of Maximal Inspiratory Pressure (MIP)Procedure or surgery
MIP is tested on all subjects on day 1, every 7 days after and on the last day of participation. To measure MIP, a subject will be suctioned, disconnected from the ventilator, and instructed to take a few spontaneous breaths. A 1-way exhalation valve connected to a NICO respiratory monitor will be placed on the ET/tracheotomy tube. The subject will be instructed to inhale and exhale as forcefully as possible for 20 seconds, followed by at least 2 minutes of rest on full mechanical ventilation support. MIP trials will be repeated 3 times, and the greatest negative pressure recorded with a NICO respiratory monitor connected to a laptop computer, which will digitize airway pressure, flow and volume signals at 100Hz. This allows for analysis of the individual pressure waves, facilitating pre-post comparisons of MIP at specific time points during inspiration.
Inspiratory Muscle Strength Training (IMST)Device
Occurs 5 days/wk using threshold IMST device-Respironics model 735. Prior to training, cuff pressure is assessed, FiO2 increased for 2 min. to keep O2 sats ≥92%. The ventilator circuit is disconnected, IMST device is attached to endotracheal or tracheotomy tube and subject is instructed to exhale then forcefully inhale for 10 breaths. The initial setting of device is set to -5cmH2O, subject must generate a negative inspiratory pressure more negative than -5cmH2O to open spring-loaded valve and receive inspiratory airflow. Pressure setting is made more negative/difficult to open by 2-5cm every few breaths until a setting is found where the patient has difficulty fully opening valve, resulting in valve flutter noise. Training pressure is then made more positive /easier by 2-4cm of H2O, so subject can fully open valve, and 4 sets of 6-10 breaths are completed. Training pressures advanced as rapidly as possible, provided the patient is able to open the valve without"valve flutter"noise.
SHAM Inspiratory Muscle Strength Training (IMST)Device
Training will also be conducted 5 days/wk with an identical IMST device that has been modified by removing the valve leaflet, which essentially removes all inspiratory loading by the device. The modified SHAM IMST device makes a whistling sound during inspiration, which enhances the sham effect. For SHAM treatment, supplemental oxygen FiO2 will be increased for two minute prior to each bout. The ventilator will be disconnected and a SHAM device will be attached to the endotracheal or tracheostomy tube. The subject will be instructed to take 6-10 breaths with a normal tidal volume through the SHAM device and will be reconnected to the ventilator for a 2-minute rest period. The process will be repeated 3 more times for a total of 4 sets of 6-10 breaths.
Diaphragm thickness measurementProcedure or surgery
Ultrasound will be used to obtain measurements of the thickness of the right hemidiaphragm. Ultrasonography of the diaphragm will be performed upon enrollment, every 2-4 days during hospitalization and as long as the patient is hospitalized or up to 28 days of participation.
Blood and Urine samplesOther
Peripheral blood and urine samples will be collected once upon study entry day (+/- 2 days), once every 2-4 days and once on final day of study participation (+/- 2days).
| Study group | Role | What they receive |
|---|---|---|
| IMST Intervention group | Experimental | IMST will be conducted 5 days per week by study staff using a threshold inspiratory muscle training device (Respironics model 735). Prior to training, the tracheal cuff pressure is assessed to ensure no air leakage and appropriate inflation. The IMST training takes approximately 15 minutes to complete. To perform IMST, FiO2 is increased for 2 minutes prior to each training bout to maintain oxygen saturation more than 92%. Receives: Procedure: Bilateral phrenic nerve stimulation and measurement of transdiaphragmatic pressure; Drug: Midazolam; Procedure: Volitional Measurement of Maximal Inspiratory Pressure (MIP); Device: Inspiratory Muscle Strength Training (IMST); Procedure: Diaphragm thickness measurement; Other: Blood and Urine samples |
| SHAM group | Sham comparator | SHAM training will also be conducted five days per week with an identical training device that has been modified by removing the valve leaflet, which essentially removes all inspiratory loading by the device. The modified SHAM device makes a whistling sound during inspiration, which enhances the sham effect. For SHAM treatment, supplemental oxygen FiO2 will be increased for two minute prior to each bout. Receives: Procedure: Bilateral phrenic nerve stimulation and measurement of transdiaphragmatic pressure; Drug: Midazolam; Procedure: Volitional Measurement of Maximal Inspiratory Pressure (MIP); Device: SHAM Inspiratory Muscle Strength Training (IMST); Procedure: Diaphragm thickness measurement; Other: Blood and Urine samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
A Change in Diaphragm Strength From Baseline as an Effect of Inspiratory Muscle Strength Training (IMST) Intervention and Sham Patients
In this randomized, interventional study, 24 CCI patients will be assigned to either a sham group or to receive IMST for up to 28 days. Evaluation of diaphragm/inspiratory muscle strength and muscle thickness will be made with three techniques: 1) non-volitional magnetic stimulation of the phrenic nerves, 2) noninvasive measurement of diaphragm thickness with ultrasound and 3) the standard, clinical method of measuring maximal inspiratory pressure (MIP). Investigators hypothesize that IMST will lead to improvements in all three measures. This study will provide information about possible effective respiratory muscle rehabilitation techniques that are likely to lead to reduced time patients will require mechanical ventilation and improved MIP and weaning outcome in long-term, failure to wean patients
Measured: Day 1, Day 3, Day 5, Day 7, Day 9, Day 11, Day 13, Day 14, Day 15, Day 17, Day 19, Day 21, Day 23, Day 25, Day 28
Secondary outcomes (2)
A Change in the Results of the Biomarkers of Inflammation From Baseline
Investigators will determine the effects of IMST on biomarkers of inflammation in patients with CCI. Investigators hypothesize that exercise will decrease markers of inflammation compared to the SHAM condition.
Measured: Day 1, Day 3, Day 5, Day 7, Day 9, Day 11, Day 13, Day 15, Day 17, Day 19, Day 21
A Change in the Urinary Excretion Markers of Muscle Catabolism From Baseline
Investigators will determine the effects of IMST on urinary excretion markers of muscle catabolism in patients with CCI. Investigators hypothesize that exercise will decrease urinary markers of catabolism compared to the SHAM condition.
Measured: Day 1, Day 3, Day 5, Day 7, Day 9, Day 11, Day 13, Day 15, Day 17, Day 19, Day 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2015 (estimated)
- Study startMar 2015
- Primary completionJul 2015
- Study completionJul 2015
Why it stopped: Unable to recruit sufficient number of patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by University of FloridaThe 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 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Responsible party
- Sponsor
- Investigators
- Daniel Martin, Ph.D., PT, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02367170
- Sponsor's protocol ID
- IRB201400889-N
- Other IDs
- GM111152
- Status last verified
- Apr 2018
- First submitted
- 21 Jan 2015
- Last updated
- 7 May 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study: Persistent Inflammation, Immunosuppression and Catabolism Syndrome (PICS): A New Horizon for Surgical Critical Care: Project 4A: Inspiratory Muscle Training and Diaphragm Strength
- ClinicalTrials.gov ID
- NCT02367170
- Acronym / sponsor ID
- IRB201400889-N
- Conditions
- Sepsis
- Keywords
- respiratory dysfunction, chronic critical illness, diaphragm weakness, sepsis, ventilator dependance
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unable to recruit sufficient number of patients
- Enrolment
- 1 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Study start
- Mar 2015
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 20 Feb 2015 (estimated)
- Results
- Posted 26 Jan 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Investigators will assess the effect of exercise on markers of inflammation and protein catabolism. This research study will further our understanding of how treating Chronic Critical illness (CCI) - related respiratory muscle weakness with strength training can not only improve muscle function, but also potentially blunt the inflammation and catabolism of Peristent Inflammation/Immunosuppression and Catabolism (PICS).
Detailed description
In this research study, investigators will assign study participants to two groups: high intensity inspiratory muscle training and low intensity inspiratory muscle training group. This research study will last up to 28 days in 24 mechanically ventilated patients with CCI. The goal is to determine if the research participants can respond to a training program by improving weaning outcomes from the ventilator. This will be determined by measurement of breathing muscle strength with magnetic stimulation, measurement of diaphragm thickness with ultrasound, inspiratory muscle training, and blood and urine samples.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IMST Intervention group | Experimental | Procedure: Bilateral phrenic nerve stimulation and measurement of transdiaphragmatic pressure, Drug: Midazolam, Procedure: Volitional Measurement of Maximal Inspiratory Pressure (MIP), Device: Inspiratory Muscle Strength Training (IMST), Procedure: Diaphragm thickness measurement, Other: Blood and Urine samplesIMST will be conducted 5 days per week by study staff using a threshold inspiratory muscle training device (Respironics model 735). Prior to training, the tracheal cuff pressure is assessed to ensure no air leakage and appropriate inflation. The IMST training takes approximately 15 minutes to complete. To perform IMST, FiO2 is increased for 2 minutes prior to each training bout to maintain oxygen saturation more than 92%. |
| SHAM group | Sham comparator | Procedure: Bilateral phrenic nerve stimulation and measurement of transdiaphragmatic pressure, Drug: Midazolam, Procedure: Volitional Measurement of Maximal Inspiratory Pressure (MIP), Device: SHAM Inspiratory Muscle Strength Training (IMST), Procedure: Diaphragm thickness measurement, Other: Blood and Urine samplesSHAM training will also be conducted five days per week with an identical training device that has been modified by removing the valve leaflet, which essentially removes all inspiratory loading by the device. The modified SHAM device makes a whistling sound during inspiration, which enhances the sham effect. For SHAM treatment, supplemental oxygen FiO2 will be increased for two minute prior to each bout. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- presence in the surgical or trauma ICU
- age of ≥18 years
- received mechanical ventilation (MV) for 3 days and expected to survive ICU stay
- ability to obtain informed consent from patient or proxy
Key exclusion criteria (22 listed)
- Inability to speak and understand English
- Uncontrollable source of sepsis with imminent death (e.g., irreversible disease state, unresectable dead bowel)
- Receiving "comfort care only" or have advanced care directives limiting resuscitative efforts
- Known HIV infection with CD4 count < 200 cells/mm
- Organ transplant recipients on immunosuppressive agent(s),
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 |
|---|---|---|
| Bilateral phrenic nerve stimulation and measurement of transdiaphragmatic pressurePressure changes are recorded. The phrenic nerves are stimulated with bilateral magnetic stimulators over the neck. Measurements will be performed on day 1, every 7 days after and on last day of participation. The FiO2 will be increased (at least 20%) for at least 2 min. prior to measurement to maintain oxygen saturation >92%. Prior to activating the stimulator, the artificial airway will be occluded with a pneumatic valve to create a quasi-isometric diaphragm contraction. The airway will be occluded for 3 seconds or less for each stimulation. The procedure will be repeated up to a maximum of 5 times per testing day. | Procedure or surgery | IMST Intervention group, SHAM group |
| MidazolamAlso: VersedIn the event a subject shows signs of distress during the Bilateral phrenic nerve stimulation and measurement of transdiaphragmatic pressures, a dose of Midazolam is available. IV (in the vein) dose from 0.5 mg to 2 mg. | Drug | IMST Intervention group, SHAM group |
| Volitional Measurement of Maximal Inspiratory Pressure (MIP)MIP is tested on all subjects on day 1, every 7 days after and on the last day of participation. To measure MIP, a subject will be suctioned, disconnected from the ventilator, and instructed to take a few spontaneous breaths. A 1-way exhalation valve connected to a NICO respiratory monitor will be placed on the ET/tracheotomy tube. The subject will be instructed to inhale and exhale as forcefully as possible for 20 seconds, followed by at least 2 minutes of rest on full mechanical ventilation support. MIP trials will be repeated 3 times, and the greatest negative pressure recorded with a NICO respiratory monitor connected to a laptop computer, which will digitize airway pressure, flow and volume signals at 100Hz. This allows for analysis of the individual pressure waves, facilitating pre-post comparisons of MIP at specific time points during inspiration. | Procedure or surgery | IMST Intervention group, SHAM group |
| Inspiratory Muscle Strength Training (IMST)Occurs 5 days/wk using threshold IMST device-Respironics model 735. Prior to training, cuff pressure is assessed, FiO2 increased for 2 min. to keep O2 sats ≥92%. The ventilator circuit is disconnected, IMST device is attached to endotracheal or tracheotomy tube and subject is instructed to exhale then forcefully inhale for 10 breaths. The initial setting of device is set to -5cmH2O, subject must generate a negative inspiratory pressure more negative than -5cmH2O to open spring-loaded valve and receive inspiratory airflow. Pressure setting is made more negative/difficult to open by 2-5cm every few breaths until a setting is found where the patient has difficulty fully opening valve, resulting in valve flutter noise. Training pressure is then made more positive /easier by 2-4cm of H2O, so subject can fully open valve, and 4 sets of 6-10 breaths are completed. Training pressures advanced as rapidly as possible, provided the patient is able to open the valve without"valve flutter"noise. | Device | IMST Intervention group |
| SHAM Inspiratory Muscle Strength Training (IMST)Training will also be conducted 5 days/wk with an identical IMST device that has been modified by removing the valve leaflet, which essentially removes all inspiratory loading by the device. The modified SHAM IMST device makes a whistling sound during inspiration, which enhances the sham effect. For SHAM treatment, supplemental oxygen FiO2 will be increased for two minute prior to each bout. The ventilator will be disconnected and a SHAM device will be attached to the endotracheal or tracheostomy tube. The subject will be instructed to take 6-10 breaths with a normal tidal volume through the SHAM device and will be reconnected to the ventilator for a 2-minute rest period. The process will be repeated 3 more times for a total of 4 sets of 6-10 breaths. | Device | SHAM group |
| Diaphragm thickness measurementUltrasound will be used to obtain measurements of the thickness of the right hemidiaphragm. Ultrasonography of the diaphragm will be performed upon enrollment, every 2-4 days during hospitalization and as long as the patient is hospitalized or up to 28 days of participation. | Procedure or surgery | IMST Intervention group, SHAM group |
| Blood and Urine samplesPeripheral blood and urine samples will be collected once upon study entry day (+/- 2 days), once every 2-4 days and once on final day of study participation (+/- 2days). | Other | IMST Intervention group, SHAM group |
Primary outcome
A Change in Diaphragm Strength From Baseline as an Effect of Inspiratory Muscle Strength Training (IMST) Intervention and Sham Patients
Time frame: Day 1, Day 3, Day 5, Day 7, Day 9, Day 11, Day 13, Day 14, Day 15, Day 17, Day 19, Day 21, Day 23, Day 25, Day 28
In this randomized, interventional study, 24 CCI patients will be assigned to either a sham group or to receive IMST for up to 28 days. Evaluation of diaphragm/inspiratory muscle strength and muscle thickness will be made with three techniques: 1) non-volitional magnetic stimulation of the phrenic nerves, 2) noninvasive measurement of diaphragm thickness with ultrasound and 3) the standard, clinical method of measuring maximal inspiratory pressure (MIP). Investigators hypothesize that IMST will lead to improvements in all three measures. This study will provide information about possible effective respiratory muscle rehabilitation techniques that are likely to lead to reduced time patients will require mechanical ventilation and improved MIP and weaning outcome in long-term, failure to wean patients
2 secondary outcomes
A Change in the Results of the Biomarkers of Inflammation From Baseline
Time frame: Day 1, Day 3, Day 5, Day 7, Day 9, Day 11, Day 13, Day 15, Day 17, Day 19, Day 21
A Change in the Urinary Excretion Markers of Muscle Catabolism From Baseline
Time frame: Day 1, Day 3, Day 5, Day 7, Day 9, Day 11, Day 13, Day 15, Day 17, Day 19, Day 21
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Daniel Martin, Ph.D., PT principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Bilateral phrenic nerve stimulation and measurement of transdiaphragmatic pressure, Midazolam and Volitional Measurement of Maximal Inspiratory Pressure (MIP) in people with Sepsis, run by University of Florida at 1 site in United States.
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 22 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: stopped early, as of the sponsor's last update on 7 May 2018. 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 United States. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Jan 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
A Change in Diaphragm Strength From Baseline as an Effect of Inspiratory Muscle Strength Training (IMST) Intervention and Sham Patients (time frame: Day 1, Day 3, Day 5, Day 7, Day 9, Day 11, Day 13, Day 14, Day 15, Day 17, Day 19, Day 21, Day 23, Day 25, Day 28). 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 7 May 2018.