Spinal Cord Injury CervicalT-PEPNCT04142814
Randomized Controlled Study on T-PEP Versus IPV Method for Lower Respiratory Airways Clearance in Tetraplegic Tracheotomized Spinal Cord Injured Patients
A study testing T-PEP and IPV in people with Spinal Cord Injury Cervical, run by Montecatone Rehabilitation Institute S.p.A. at 1 site in Italy.
Trial summary
In tetraplegic patients with complete cervical spinal cord injury, respiratory complications are very frequent, especially in the sub-acute phase: the lungs often become obstructed due to the accumulation of secretions and the contemporary inefficiency of the cough mechanism. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injury Cervical
- What is being tested?
- T-PEP and IPV
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteItaly
- Study dates
- Feb 2022to Aug 2023
- 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
- spinal cord injury due to traumatic or non-traumatic etiology;
- neurological level from C4 to C7 (included)
- complete spinal cord injury, classifiable as "A" grade according to the Asia Impairment Scale (AIS);
- distance from the spinal cord injury event from 1 to 5 weeks;
- first admission to Montecatone R.I. (in particular to the Critical Care Unit);
- patients with middle-basal hypoventilation;
Show all 10Show fewer
- patients in partial or continuous mechanical ventilation;
- patients with tracheotomy;
- patients capable of giving meaningful consent;
- collaborating patients.
Who cannot join
- thoracic trauma with non-drained thoracic fractures and / or pneumothorax and / or hemorrhage;
- pleural effusion;
- significant hemodynamic instability needing amines administration and / or Shock Index > 1.5;
- patients with tracheoesophageal fistulae;
- patients with severe acquired brain injury;
- patients with ongoing sepsis;
- patients with ongoing pregnancy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Controlled Study on the Evaluation of the T-PEP Method Based on Positive Expiratory Pressure Versus Intrapulmonary Percussive Ventilation for Lower Respiratory Airways Clearance in Sub-acute, Tetraplegic, Tracheotomized Spinal Cord Injured Patients
In tetraplegic patients with complete cervical spinal cord injury, respiratory complications are very frequent, especially in the sub-acute phase: the lungs often become obstructed due to the accumulation of secretions and the contemporary inefficiency of the cough mechanism. The present pilot study aims, in the context of a rehabilitative Critical Care Unit, at evaluating a not yet published method, called "T-PEP" and based on the principle of Positive Expiratory Pressure, applicable to tracheotomised and mechanically ventilated patients. This method, conceptually simple and low cost, is compared with a known method based on the principle of Percussive Intrapulmonary Ventilation (IPV). Safety and efficacy issues are covered.
Read the detailed description
Respiratory complications are very frequent, especially in the sub-acute phase following a spinal cord injury and must be treated to avoid even very serious outcomes. In the patient with a complete cervical spinal cord injury (and therefore tetraplegic, from a motor perspective), the lungs often become obstructed due to the accumulation of secretions and the contemporary inefficiency of the physiological mechanism of the cough. Various methods for bronchial clearance are known, but when the patient is tracheotomized and the secretions accumulate in the deepest part of the lung, nowadays the only described method available to mobilize such secretions and allow more efficient respiratory exchanges is based on the principle of Percussive Intrapulmonary Ventilation (IPV). It requires a special device, equipped with a pneumatic air generator, connected to the tracheal cannula. Such treatment needs the assistance of highly trained and expert operators, moreover IPV is a quite complex and expensive technique which has to be applied in a prudential manner in such tetraplegic patients, especially because they show significant hemodynamic instability in the acute/sub-acute phase after the spinal cord lesion.
The principle of Positive Expiratory Pressure (PEP) is already known for its efficacy in the secretions' clearance of the lower respiratory airways in other pathological conditions. However, in its classic modalities, it requires the preservation of the functionality of the respiratory muscles. To circumvent this limit in tetraplegic and tracheotomized patients, a respiratory physiotherapeutic procedure called "T-PEP" has been developed at the Montecatone Rehabilitation Institute. Such method is conceptually simple and low cost, it requires the manual assistance of a trained physiotherapist and the use of some components of common use in the clinical practice of Critical Care Units.
The present pilot randomized controlled trial aims at comparing the T-PEP and IPV methods, assigned to 2 parallel arms (1:1 allocation ratio), in the context of the Critical Care Unit of the Montecatone Rehabilitation Institute hospital, in sub-acute, tetraplegic, tracheotomized, mechanically ventilated, spinal cord injured patients. The trial covers safety and efficacy issues; cognitive performances are also addressed.
- Conditions
- Spinal Cord Injury Cervical
- Being tested
- T-PEP, IPV
- Keywords
- Lower respiratory airways clearance, Deep lung clearance, Secretions overproduction, Positive Expiratory Pressure, Intrapulmonary Percussive Ventilation, Tetraplegia, Tracheotomy, Critical Care Unit, Mechanical ventilation, Respiratory physiotherapy
- Medical subject headings
- Quadriplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
T-PEPProcedure or surgery
First of all, a corrugated tube for ventilation is assembled: in one end with an antibacterial filter for ventilation and then an inflation system (like Auxiliary Manual Breathing Unit - AMBU); in the other end with a connector and then a one-way PEP Valve. The latter holds a junction for the tracheal cannula and a pressure gauge. A Venturi Resistor is placed in the expiratory part of the PEP Valve.
After connection to the tracheal cannula, the disostructive maneuver is manually executed by a respiratory physiotherapist.
IPVProcedure or surgery
IPV is delivered via a commercial device that can be set by frequency, duration of inspiratory time, inspiratory-expiratory ratio and positive end-expiratory pressure, based on patients characteristics and clinical needs. It is connected to the patient's tracheal cannula via a Mount catheter. The air supplied is sterile, due to the presence of an antibacterial filter present in the device.
| Study group | Role | What they receive |
|---|---|---|
| T-PEP | Experimental | Each T-PEP session includes 10 inspiratory/expiratory cycles, repeated 3 times and interspersed by a pause of about 3 minutes.
Each session will be immediately followed by bronchoaspiration and/or Mechanical Insufflation-Exsufflation (MI-E).
Sessions will take place at least twice a day for a number of days until the attainment of an effective pulmonary ventilation (as detected by thoracic auscultation), then continued for a further 3 days (at least 2 times a day) for the outcome stabilization, as confirmed also by arterial-blood gas test (ABG), spirometry, chest X-ray and chest ultrasound.
T-PEP sessions will take place at least 1 hour after meals or nutrition via nasogastric tube.
Tracheal cannula will be kept constantly cuffed during the sessions. Ipratropium Bromide treatment will be on place from study entry until at least 4 weeks after the attainment of a stabilized effective pulmonary ventilation. Receives: Procedure: T-PEP |
| IPV | Active comparator | Each IPV session includes 3 treatment cycles, interspersed with a pause, consisting of a first high-frequency steps, lasting about 5 minutes, immediately followed by a second low-frequency step lasting approximately one minute.
Each session will be immediately followed by bronchoaspiration and/or Mechanical Insufflation-Exsufflation (MI-E).
Sessions will take place at least twice a day for a number of days until the attainment of an effective pulmonary ventilation (by thoracic auscultation), then continued for a further 3 days (at least 2 times a day) for outcome stabilization, as confirmed by ABG test, spirometry, chest X-ray and chest ultrasound.
IPV sessions will take place at least 1 hour after meals or nutrition via nasogastric tube.
Tracheal cannula will be kept constantly cuffed during the sessions. Ipratropium Bromide treatment will be on place from study entry until at least 4 weeks, after the attainment of a stabilized effective pulmonary ventilation. Receives: Procedure: IPV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events
Incidence of adverse events in the treatment period and during the subsequent follow-up, directly correlated with the lower airways cleaning treatments under investigation
Measured: Through the whole period of clearance treatment to attain a stabilized effective pulmonary ventilation (whole period length is 2 weeks on average) until the following 4 weeks
Secondary outcomes (16)
Time needed for attainment of a stabilized effective pulmonary ventilation
Number of days needed to attain the stabilization of an effective pulmonary ventilation, as confirmed simultaneously by all the following examinations: chest auscultation, ABG (for respiratory exchanges efficiency), spirometry (in particular: Forced Expiratory Flow 75% [FEF 75], for pulmonary patency), chest X-ray and chest ultrasound.
Measured: Through the whole period of clearance treatment to attain a stabilized effective pulmonary ventilation (whole period length is 2 weeks on average)
Recurrence of lower airways obstruction
Incidence of recurrence of lower airways obstructions requiring retreatment with the lower airways treatments under investigation, in the study period following the attainment of stabilized effective pulmonary ventilation
Measured: From the attainment of stabilized effective pulmonary ventilation until 3 months later
Incidence of infections of lower respiratory airways
Incidence of acute infections of the lower respiratory airways, throughout the study period.
Measured: Through the whole period of clearance treatment to attain a stabilized effective pulmonary ventilation (whole period length is 2 weeks on average) and through the following 3 months
Incidence of sepsis
Incidence of sepsis related to acute infections of the lower respiratory airways, throughout the study period
Measured: Through the whole period of clearance treatment to attain a stabilized effective pulmonary ventilation (whole period length is 2 weeks on average) and through the following 3 months
Time needed for weaning from mechanical ventilation, from its start
Number of days needed to wean from mechanical ventilation, starting from the mechanical ventilation starting date (also if previously occurred in a sending hospital)
Measured: From mechanical ventilation start date until mechanical ventilation end date (up to 1 year)
Time needed for weaning from mechanical ventilation, from hospital admission
Number of days needed to wean from mechanical ventilation, starting from the date of admission to the Montecatone R.I. hospital
Measured: From admission date to Montecatone R.I. until mechanical ventilation end date (up to 1 year)
Evaluation of cognitive performance: attention and memory - 1
Neuropsychological test: Preliminary Neuropsychological Battery
Measured: Baseline (initial visit); day of attainment of stabilized effective pulmonary ventilation; 4 weeks after the day of attainment of stabilized effective pulmonary ventilation; 3 months after the attainment of stabilized effective pulmonary ventilation
Evaluation of cognitive performance: attention and memory - 2
Neuropsychological test: Verbal Span
Measured: Baseline (initial visit); day of attainment of stabilized effective pulmonary ventilation; 4 weeks after the day of attainment of stabilized effective pulmonary ventilation; 3 months after the attainment of stabilized effective pulmonary ventilation
Evaluation of cognitive performance: attention and memory - 3
Neuropsychological test: Immediate Visual Memory
Measured: Baseline (initial visit); day of attainment of stabilized effective pulmonary ventilation; 4 weeks after the day of attainment of stabilized effective pulmonary ventilation; 3 months after the attainment of stabilized effective pulmonary ventilation
Evaluation of cognitive performance: attention and memory - 4
Neuropsychological test: Digit Symbol Substitution test
Measured: Baseline (initial visit); day of attainment of stabilized effective pulmonary ventilation; 4 weeks after the day of attainment of stabilized effective pulmonary ventilation; 3 months after the attainment of stabilized effective pulmonary ventilation
Evaluation of cognitive performance: logical and executive functions - 1
Neuropsychological test: Verbal Fluency
Measured: Day of attainment of stabilized effective pulmonary ventilation; 4 weeks after the day of attainment of stabilized effective pulmonary ventilation; 3 months after the day of attainment of stabilized effective pulmonary ventilation
Evaluation of cognitive performance: logical and executive functions - 2
Neuropsychological test: Progressive Matrices
Measured: Day of attainment of stabilized effective pulmonary ventilation; 4 weeks after the day of attainment of stabilized effective pulmonary ventilation; 3 months after the day of attainment of stabilized effective pulmonary ventilation
Evaluation of cognitive performance: logical and executive functions - 3
Neuropsychological test: Verbal Analogies
Measured: Day of attainment of stabilized effective pulmonary ventilation; 4 weeks after the day of attainment of stabilized effective pulmonary ventilation; 3 months after the day of attainment of stabilized effective pulmonary ventilation
Evaluation of cognitive performance: social cognition
Neuropsychological test: Eyes Test
Measured: 3 months after the day of attainment of stabilized effective pulmonary ventilation
Costs of the T-PEP and IPV treatments - 1
Average costs of equipments used in the overall number of sessions with T-PEP or IPV treatments, needed to attain stabilized effective pulmonary ventilation
Measured: Through the whole period of clearance treatment to attain a stabilized effective pulmonary ventilation (whole period length is 2 weeks on average)
Costs of the T-PEP and IPV treatments - 2
Average costs of consumables used in the overall number of sessions with T-PEP or IPV treatments, needed to attain stabilized effective pulmonary ventilation
Measured: Through the whole period of clearance treatment to attain a stabilized effective pulmonary ventilation (whole period length is 2 weeks on average)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2019
- Study startFeb 2022 (estimated)
- Primary completionJul 2023 (estimated)
- Study completionAug 2023 (estimated)
Why it stopped: Patients case mix changed and did not match anymore with selection criteria
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord Injury CervicalStudies 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
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Montecatone Rehabilitation Institute S.p.A.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carlotta Stopazzoni, MD, Principal investigator, Montecatone Rehanilitation Institute SpA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04142814
- Sponsor's protocol ID
- CE-378/2018/SPER/AUSLIM
- Acronym
- T-PEP
- Status last verified
- Apr 2022
- First submitted
- 22 Oct 2019
- Last updated
- 28 Apr 2022
- Results posted
- No
- Data monitoring committee
- 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 28 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Study on the Evaluation of the T-PEP Method Based on Positive Expiratory Pressure Versus Intrapulmonary Percussive Ventilation for Lower Respiratory Airways Clearance in Sub-acute, Tetraplegic, Tracheotomized Spinal Cord Injured Patients
- ClinicalTrials.gov ID
- NCT04142814
- Acronym / sponsor ID
- T-PEP / CE-378/2018/SPER/AUSLIM
- Conditions
- Spinal Cord Injury Cervical
- Keywords
- Lower respiratory airways clearance, Deep lung clearance, Secretions overproduction, Positive Expiratory Pressure, Intrapulmonary Percussive Ventilation, Tetraplegia, Tracheotomy, Critical Care Unit
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Patients case mix changed and did not match anymore with selection criteria
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Montecatone Rehabilitation Institute S.p.A.University, hospital or other
- Study start
- Feb 2022 (estimated)
- Primary completion
- Jul 2023 (estimated)
- Study completion
- Aug 2023 (estimated)
- First posted
- 29 Oct 2019 (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.
In tetraplegic patients with complete cervical spinal cord injury, respiratory complications are very frequent, especially in the sub-acute phase: the lungs often become obstructed due to the accumulation of secretions and the contemporary inefficiency of the cough mechanism. The present pilot study aims, in the context of a rehabilitative Critical Care Unit, at evaluating a not yet published method, called "T-PEP" and based on the principle of Positive Expiratory Pressure, applicable to tracheotomised and mechanically ventilated patients. This method, conceptually simple and low cost, is compared with a known method based on the principle of Percussive Intrapulmonary Ventilation (IPV). Safety and efficacy issues are covered.
Detailed description
Respiratory complications are very frequent, especially in the sub-acute phase following a spinal cord injury and must be treated to avoid even very serious outcomes. In the patient with a complete cervical spinal cord injury (and therefore tetraplegic, from a motor perspective), the lungs often become obstructed due to the accumulation of secretions and the contemporary inefficiency of the physiological mechanism of the cough. Various methods for bronchial clearance are known, but when the patient is tracheotomized and the secretions accumulate in the deepest part of the lung, nowadays the only described method available to mobilize such secretions and allow more efficient respiratory exchanges is based on the principle of Percussive Intrapulmonary Ventilation (IPV). It requires a special device, equipped with a pneumatic air generator, connected to the tracheal cannula. Such treatment needs the assistance of highly trained and expert operators, moreover IPV is a quite complex and expensive technique which has to be applied in a prudential manner in such tetraplegic patients, especially because they show significant hemodynamic instability in the acute/sub-acute phase after the spinal cord lesion.
The principle of Positive Expiratory Pressure (PEP) is already known for its efficacy in the secretions' clearance of the lower respiratory airways in other pathological conditions. However, in its classic modalities, it requires the preservation of the functionality of the respiratory muscles. To circumvent this limit in tetraplegic and tracheotomized patients, a respiratory physiotherapeutic procedure called "T-PEP" has been developed at the Montecatone Rehabilitation Institute. Such method is conceptually simple and low cost, it requires the manual assistance of a trained physiotherapist and the use of some components of common use in the clinical practice of Critical Care Units.
The present pilot randomized controlled trial aims at comparing the T-PEP and IPV methods, assigned to 2 parallel arms (1:1 allocation ratio), in the context of the Critical Care Unit of the Montecatone Rehabilitation Institute hospital, in sub-acute, tetraplegic, tracheotomized, mechanically ventilated, spinal cord injured patients. The trial covers safety and efficacy issues; cognitive performances are also addressed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| T-PEP | Experimental | Procedure: T-PEPEach T-PEP session includes 10 inspiratory/expiratory cycles, repeated 3 times and interspersed by a pause of about 3 minutes. Each session will be immediately followed by bronchoaspiration and/or Mechanical Insufflation-Exsufflation (MI-E). Sessions will take place at least twice a day for a number of days until the attainment of an effective pulmonary ventilation (as detected by thoracic auscultation), then continued for a further 3 days (at least 2 times a day) for the outcome stabilization, as confirmed also by arterial-blood gas test (ABG), spirometry, chest X-ray and chest ultrasound. T-PEP sessions will take place at least 1 hour after meals or nutrition via nasogastric tube. Tracheal cannula will be kept constantly cuffed during the sessions. Ipratropium Bromide treatment will be on place from study entry until at least 4 weeks after the attainment of a stabilized effective pulmonary ventilation. |
| IPV | Active comparator | Procedure: IPVEach IPV session includes 3 treatment cycles, interspersed with a pause, consisting of a first high-frequency steps, lasting about 5 minutes, immediately followed by a second low-frequency step lasting approximately one minute. Each session will be immediately followed by bronchoaspiration and/or Mechanical Insufflation-Exsufflation (MI-E). Sessions will take place at least twice a day for a number of days until the attainment of an effective pulmonary ventilation (by thoracic auscultation), then continued for a further 3 days (at least 2 times a day) for outcome stabilization, as confirmed by ABG test, spirometry, chest X-ray and chest ultrasound. IPV sessions will take place at least 1 hour after meals or nutrition via nasogastric tube. Tracheal cannula will be kept constantly cuffed during the sessions. Ipratropium Bromide treatment will be on place from study entry until at least 4 weeks, after the attainment of a stabilized effective pulmonary ventilation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- spinal cord injury due to traumatic or non-traumatic etiology;
- neurological level from C4 to C7 (included)
- complete spinal cord injury, classifiable as "A" grade according to the Asia Impairment Scale (AIS);
- distance from the spinal cord injury event from 1 to 5 weeks;
- first admission to Montecatone R.I. (in particular to the Critical Care Unit);
Key exclusion criteria (7 listed)
- thoracic trauma with non-drained thoracic fractures and / or pneumothorax and / or hemorrhage;
- pleural effusion;
- significant hemodynamic instability needing amines administration and / or Shock Index > 1.5;
- patients with tracheoesophageal fistulae;
- patients with severe acquired brain injury;
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 |
|---|---|---|
| T-PEPFirst of all, a corrugated tube for ventilation is assembled: in one end with an antibacterial filter for ventilation and then an inflation system (like Auxiliary Manual Breathing Unit - AMBU); in the other end with a connector and then a one-way PEP Valve. The latter holds a junction for the tracheal cannula and a pressure gauge. A Venturi Resistor is placed in the expiratory part of the PEP Valve. After connection to the tracheal cannula, the disostructive maneuver is manually executed by a respiratory physiotherapist. | Procedure or surgery | T-PEP |
| IPVIPV is delivered via a commercial device that can be set by frequency, duration of inspiratory time, inspiratory-expiratory ratio and positive end-expiratory pressure, based on patients characteristics and clinical needs. It is connected to the patient's tracheal cannula via a Mount catheter. The air supplied is sterile, due to the presence of an antibacterial filter present in the device. | Procedure or surgery | IPV |
Primary outcome
Incidence of adverse events
Time frame: Through the whole period of clearance treatment to attain a stabilized effective pulmonary ventilation (whole period length is 2 weeks on average) until the following 4 weeks
Incidence of adverse events in the treatment period and during the subsequent follow-up, directly correlated with the lower airways cleaning treatments under investigation
16 secondary outcomes
Time needed for attainment of a stabilized effective pulmonary ventilation
Time frame: Through the whole period of clearance treatment to attain a stabilized effective pulmonary ventilation (whole period length is 2 weeks on average)
Recurrence of lower airways obstruction
Time frame: From the attainment of stabilized effective pulmonary ventilation until 3 months later
Incidence of infections of lower respiratory airways
Time frame: Through the whole period of clearance treatment to attain a stabilized effective pulmonary ventilation (whole period length is 2 weeks on average) and through the following 3 months
Incidence of sepsis
Time frame: Through the whole period of clearance treatment to attain a stabilized effective pulmonary ventilation (whole period length is 2 weeks on average) and through the following 3 months
Time needed for weaning from mechanical ventilation, from its start
Time frame: From mechanical ventilation start date until mechanical ventilation end date (up to 1 year)
Time needed for weaning from mechanical ventilation, from hospital admission
Time frame: From admission date to Montecatone R.I. until mechanical ventilation end date (up to 1 year)
Evaluation of cognitive performance: attention and memory - 1
Time frame: Baseline (initial visit); day of attainment of stabilized effective pulmonary ventilation; 4 weeks after the day of attainment of stabilized effective pulmonary ventilation; 3 months after the attainment of stabilized effective pulmonary ventilation
Evaluation of cognitive performance: attention and memory - 2
Time frame: Baseline (initial visit); day of attainment of stabilized effective pulmonary ventilation; 4 weeks after the day of attainment of stabilized effective pulmonary ventilation; 3 months after the attainment of stabilized effective pulmonary ventilation
Evaluation of cognitive performance: attention and memory - 3
Time frame: Baseline (initial visit); day of attainment of stabilized effective pulmonary ventilation; 4 weeks after the day of attainment of stabilized effective pulmonary ventilation; 3 months after the attainment of stabilized effective pulmonary ventilation
Evaluation of cognitive performance: attention and memory - 4
Time frame: Baseline (initial visit); day of attainment of stabilized effective pulmonary ventilation; 4 weeks after the day of attainment of stabilized effective pulmonary ventilation; 3 months after the attainment of stabilized effective pulmonary ventilation
Evaluation of cognitive performance: logical and executive functions - 1
Time frame: Day of attainment of stabilized effective pulmonary ventilation; 4 weeks after the day of attainment of stabilized effective pulmonary ventilation; 3 months after the day of attainment of stabilized effective pulmonary ventilation
Evaluation of cognitive performance: logical and executive functions - 2
Time frame: Day of attainment of stabilized effective pulmonary ventilation; 4 weeks after the day of attainment of stabilized effective pulmonary ventilation; 3 months after the day of attainment of stabilized effective pulmonary ventilation
Evaluation of cognitive performance: logical and executive functions - 3
Time frame: Day of attainment of stabilized effective pulmonary ventilation; 4 weeks after the day of attainment of stabilized effective pulmonary ventilation; 3 months after the day of attainment of stabilized effective pulmonary ventilation
Evaluation of cognitive performance: social cognition
Time frame: 3 months after the day of attainment of stabilized effective pulmonary ventilation
Costs of the T-PEP and IPV treatments - 1
Time frame: Through the whole period of clearance treatment to attain a stabilized effective pulmonary ventilation (whole period length is 2 weeks on average)
Costs of the T-PEP and IPV treatments - 2
Time frame: Through the whole period of clearance treatment to attain a stabilized effective pulmonary ventilation (whole period length is 2 weeks on average)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2022.
- 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.
Carlotta Stopazzoni, MD principal investigator
Montecatone Rehanilitation Institute SpA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing T-PEP and IPV in people with Spinal Cord Injury Cervical, run by Montecatone Rehabilitation Institute S.p.A. at 1 site in Italy.
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 10 inclusion and 7 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: withdrawn, as of the sponsor's last update on 28 Apr 2022. 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 Italy. 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 was withdrawn before enrolling participants, so there are no results.
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?
Incidence of adverse events (time frame: Through the whole period of clearance treatment to attain a stabilized effective pulmonary ventilation (whole period length is 2 weeks on average) until the following 4 weeks). 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 28 Apr 2022.