Respiratory Distress Syndrome, AdultNCT03712215
STUDY OF ELECTRICAL STIMULATION IN PULMONARY FUNCTION IN INTENSIVE CARE UNIT
A study testing Rehabilitation in people with Respiratory Distress Syndrome, Adult, run by Universidade Metodista de Piracicaba at 1 site in Brazil.
Trial summary
Introduction: The Mechanical Ventilation (MV), a support method used in Intensive Care Units (ICU), reaches approximately 90% of critical patients whose withdrawal process represents 40% of the total time of their use. Read more about this study
- Who is it for?
- Ages 60 to 80 years
- Conditions the study is for
- Respiratory Distress Syndrome, Adult
- What is being tested?
- Rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- 4 Sep 2018to 31 Jan 2019
- 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 60 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals of both sexes aged 60 years and older up to 80 years,
- in invasive MV for more than 48 hours,
- with respiratory drive,
- using MV in the mode of intermittent mandatory synchronized ventilation (VMIS) or (VPS),
- connected to the orotracheal tube or via tracheostomy,
- hemodynamically stable,
- neuromuscular junction of the entire diaphragm,
- absence of sedatives.
Who cannot join
- presence of pacemaker, hyperthermia (temperature> 38 ° C),
- use of neuromuscular blockers,
- use of thoracic drains, generalized edema,
- cutaneous lesion in the area of intervention with TEDS.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: ELECTRICAL DIAPHRAGMATIC STIMULATION IN PULMONARY FUNCTION OF CRITICAL PATIENTS
Introduction: The Mechanical Ventilation (MV), a support method used in Intensive Care Units (ICU), reaches approximately 90% of critical patients whose withdrawal process represents 40% of the total time of their use. For this purpose Transcutaneous electrical diaphragmatic stimulation (TEDS), which by means of electrodes placed in motor action points on the phrenic nerve tend to provide improvement of the diaphragm muscle function. Objective: To analyze the effect of two protocols of transcutaneous electrical diaphragmatic stimulation on the ventilatory and cardiorespiratory parameters of critically ill patients. Method: Clinical, longitudinal, prospective, quantitative, single center trial will be performed with 30 (thirty) participants in invasive mechanical ventilatory support, randomly divided into three groups: Experimental Group 1 (GE-1; n = 10) where they will be submitted to the TEDS protocol; Experimental Group 2 (GE-2; n = 10), where they will be submitted to the TEDS protocol based on the studies of Cancelliero et al. (2012); Control Group (GC; n = 10) where they will not be submitted to TEDS. All groups will receive physiotherapeutic care from the staff of the adult ICU of the FHCGV. The interventions will consist of ten sessions of Physical Therapy in each participant in the afternoon shift, for ten consecutive days, 1 time a day. For the TEDS procedure, the Orion TENS II (Orion-SP-Brazil) model will be used, the Wright analogue respirometer (Spire-SP-Brazil) will be used for the minute volume evaluation (V'). The variables of systolic blood pressure (SBP), diastolic blood pressure (DBP), heart rate (HR) and peripheral oxygen saturation (SpO2) will also be monitored in order to verify if the TEDS application interferes with the hemodynamic variables of these patients. The data collected will be linked to Microsoft Office Excel® 2010 software and later transformed into tables and graphs. The information collected will be submitted to statistical analysis through the statistical package SPSS 22.0, applying the descriptive statistics for the characterization of the sample and then selecting the specific tests for the respective variances, adopting a level of significance of p≤0.05 for statistical inferences.
- Conditions
- Respiratory Distress Syndrome, Adult
- Being tested
- Rehabilitation
- Keywords
- Mechanical Ventilation, Electrical Stimulation, Diaphragm, Ventilometry, Physiotherapy
- Medical subject headings
- Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RehabilitationOther
diaphragmatic electrical stimulation
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group 1 | Experimental | synchronized FES mode, according to the parameters based on the Gueddes et al., (1991): current frequency (F) 30 Hz; pulse width (T) 0,4 ms; upload time (Rise) 1s; time of muscle contraction (On time) 1 s; down time (Decay) 2s e muscle relaxation time (Off time) 1 s. Receives: Other: Rehabilitation |
| Experimental Group 2 | Experimental | the same apparatus will be used, differing in the parameters that will be based on the studies of Cancelliero et al., (2012) for the EDET procedure, being used in synchronized FES mode, with frequency of 30 Hz; pulse width (T) 0,4 ms, climb (ramp) of 0,7 s (maximum value). The support was of 0.4 s, already standardized and fixed in the apparatus Receives: Other: Rehabilitation |
| Control Group | No intervention | The control group (CG) with the same characteristics of the experimental groups will perform conventional physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Minute volume
For the evaluation of the minute volume will be used Wright analog breathing apparatus. This analysis will occur during the initial evaluation and at the end of each service. For measurement, the ventilometer will be connected to a filter of the brand HMEF UNDIS MEDICAL for adults with extensible trachea of 15 cm, and it is attached directly to the tracheostomy cannula. The patient will remain for a maximum of one minute outside the MV, obstructing the nose with nose clip to thus measure the minute volume spontaneously.
Measured: From date of randomization until the date of first documented progression, assessed up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2018
- Study start4 Sep 2018
- Primary completion31 Jan 2019
- Study completion31 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Respiratory Distress Syndrome, AdultStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Metodista de Piracicaba
- Sponsor type
- University, hospital or other
- Collaborators
- Universidade do Estado do Pará
- Responsible party
- Principal investigator, Rodrigo Santiago Barbosa Rocha, Phd, Universidade Metodista de Piracicaba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03712215
- Sponsor's protocol ID
- 1.762.021
- Status last verified
- Aug 2020
- First submitted
- 3 Sep 2018
- Last updated
- 13 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Yabek SM, Jarmakani JM. Sinus node dysfunction in children, adolescents, and young adults. Pediatrics. 1978 Apr;61(4):593-8.
PubMed 662485Wachtel SS, Basrur P, Koo GC. Recessive male-determining genes. Cell. 1978 Sep;15(1):279-81. doi: 10.1016/0092-8674(78)90103-4.
PubMed 699047Geddes LA, Voorhees WD, Bourland JD, Riscili CE. Optimum stimulus frequency for contracting the inspiratory muscles with chest-surface electrodes to produce artificial respiration. Ann Biomed Eng. 1990;18(1):103-8. doi: 10.1007/BF02368420.
PubMed 2306029Krymskii LD, Nestaiko GV. [Scanning electron microscopy of vessels in normal and pathologic states]. Vestn Akad Med Nauk SSSR. 1975;(11):71-6. No abstract available. Russian.
PubMed 775835Arguelles JE, Franatovic Y, Romo-Salas F, Aldrete JA. Intrabiliary pressure changes produced by narcotic drugs and inhalation anesthetics in guinea pigs. Anesth Analg. 1979 Mar-Apr;58(2):120-3.
PubMed 35040
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ELECTRICAL DIAPHRAGMATIC STIMULATION IN PULMONARY FUNCTION OF CRITICAL PATIENTS
- ClinicalTrials.gov ID
- NCT03712215
- Acronym / sponsor ID
- 1.762.021
- Conditions
- Respiratory Distress Syndrome, Adult
- Keywords
- Mechanical Ventilation, Electrical Stimulation, Diaphragm, Ventilometry, Physiotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Universidade Metodista de PiracicabaUniversity, hospital or other
- Collaborators
- Universidade do Estado do Pará
- Study start
- 4 Sep 2018 (actual)
- Primary completion
- 31 Jan 2019 (actual)
- Study completion
- 31 Jan 2019 (actual)
- First posted
- 19 Oct 2018 (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.
Introduction: The Mechanical Ventilation (MV), a support method used in Intensive Care Units (ICU), reaches approximately 90% of critical patients whose withdrawal process represents 40% of the total time of their use. For this purpose Transcutaneous electrical diaphragmatic stimulation (TEDS), which by means of electrodes placed in motor action points on the phrenic nerve tend to provide improvement of the diaphragm muscle function. Objective: To analyze the effect of two protocols of transcutaneous electrical diaphragmatic stimulation on the ventilatory and cardiorespiratory parameters of critically ill patients. Method: Clinical, longitudinal, prospective, quantitative, single center trial will be performed with 30 (thirty) participants in invasive mechanical ventilatory support, randomly divided into three groups: Experimental Group 1 (GE-1; n = 10) where they will be submitted to the TEDS protocol; Experimental Group 2 (GE-2; n = 10), where they will be submitted to the TEDS protocol based on the studies of Cancelliero et al. (2012); Control Group (GC; n = 10) where they will not be submitted to TEDS. All groups will receive physiotherapeutic care from the staff of the adult ICU of the FHCGV. The interventions will consist of ten sessions of Physical Therapy in each participant in the afternoon shift, for ten consecutive days, 1 time a day. For the TEDS procedure, the Orion TENS II (Orion-SP-Brazil) model will be used, the Wright analogue respirometer (Spire-SP-Brazil) will be used for the minute volume evaluation (V'). The variables of systolic blood pressure (SBP), diastolic blood pressure (DBP), heart rate (HR) and peripheral oxygen saturation (SpO2) will also be monitored in order to verify if the TEDS application interferes with the hemodynamic variables of these patients. The data collected will be linked to Microsoft Office Excel® 2010 software and later transformed into tables and graphs. The information collected will be submitted to statistical analysis through the statistical package SPSS 22.0, applying the descriptive statistics for the characterization of the sample and then selecting the specific tests for the respective variances, adopting a level of significance of p≤0.05 for statistical inferences.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Experimental Group 1 | Experimental | Other: Rehabilitationsynchronized FES mode, according to the parameters based on the Gueddes et al., (1991): current frequency (F) 30 Hz; pulse width (T) 0,4 ms; upload time (Rise) 1s; time of muscle contraction (On time) 1 s; down time (Decay) 2s e muscle relaxation time (Off time) 1 s. |
| Experimental Group 2 | Experimental | Other: Rehabilitationthe same apparatus will be used, differing in the parameters that will be based on the studies of Cancelliero et al., (2012) for the EDET procedure, being used in synchronized FES mode, with frequency of 30 Hz; pulse width (T) 0,4 ms, climb (ramp) of 0,7 s (maximum value). The support was of 0.4 s, already standardized and fixed in the apparatus |
| Control Group | No intervention | –The control group (CG) with the same characteristics of the experimental groups will perform conventional physiotherapy |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Individuals of both sexes aged 60 years and older up to 80 years,
- in invasive MV for more than 48 hours,
- with respiratory drive,
- using MV in the mode of intermittent mandatory synchronized ventilation (VMIS) or (VPS),
- connected to the orotracheal tube or via tracheostomy,
Key exclusion criteria (4 listed)
- presence of pacemaker, hyperthermia (temperature> 38 ° C),
- use of neuromuscular blockers,
- use of thoracic drains, generalized edema,
- cutaneous lesion in the area of intervention with TEDS.
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 |
|---|---|---|
| Rehabilitationdiaphragmatic electrical stimulation | Other | Experimental Group 1, Experimental Group 2 |
Primary outcome
Minute volume
Time frame: From date of randomization until the date of first documented progression, assessed up to 24 months
For the evaluation of the minute volume will be used Wright analog breathing apparatus. This analysis will occur during the initial evaluation and at the end of each service. For measurement, the ventilometer will be connected to a filter of the brand HMEF UNDIS MEDICAL for adults with extensible trachea of 15 cm, and it is attached directly to the tracheostomy cannula. The patient will remain for a maximum of one minute outside the MV, obstructing the nose with nose clip to thus measure the minute volume spontaneously.
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 13 Aug 2020.
- Results publication: PubMed 662485Yabek SM, Jarmakani JM. Sinus node dysfunction in children, adolescents, and young adults. Pediatrics. 1978 Apr;61(4):593-8.
- Results publication: PubMed 699047Wachtel SS, Basrur P, Koo GC. Recessive male-determining genes. Cell. 1978 Sep;15(1):279-81. doi: 10.1016/0092-8674(78)90103-4.
- Results publication: PubMed 2306029Geddes LA, Voorhees WD, Bourland JD, Riscili CE. Optimum stimulus frequency for contracting the inspiratory muscles with chest-surface electrodes to produce artificial respiration. Ann Biomed Eng. 1990;18(1):103-8. doi: 10.1007/BF02368420.
- Results publication: PubMed 775835Krymskii LD, Nestaiko GV. [Scanning electron microscopy of vessels in normal and pathologic states]. Vestn Akad Med Nauk SSSR. 1975;(11):71-6. No abstract available. Russian.
- Results publication: PubMed 35040Arguelles JE, Franatovic Y, Romo-Salas F, Aldrete JA. Intrabiliary pressure changes produced by narcotic drugs and inhalation anesthetics in guinea pigs. Anesth Analg. 1979 Mar-Apr;58(2):120-3.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rehabilitation in people with Respiratory Distress Syndrome, Adult, run by Universidade Metodista de Piracicaba 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 8 inclusion and 4 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 13 Aug 2020. 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?
Minute volume (time frame: From date of randomization until the date of first documented progression, assessed up to 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03712215, which also lists 5 linked publications.
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 13 Aug 2020.