Randomized Controlled Study on T-PEP Versus IPV Method for Lower Respiratory Airways Clearance in Tetraplegic Tracheotomized Spinal Cord Injured Patients

2019-11-03 15:11:01 | BioPortfolio


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.


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


Spinal Cord Injury Cervical




Montecatone Rehabilitation Institute S.p.A.


Not yet recruiting


Montecatone Rehabilitation Institute S.p.A.

Results (where available)

View Results


Published on BioPortfolio: 2019-11-03T15:11:01-0500

Clinical Trials [3757 Associated Clinical Trials listed on BioPortfolio]

Study to Assess the Efficacy and Safety of VX-210 in Subjects With Acute Traumatic Cervical Spinal Cord Injury

The purpose of this study is to determine the efficacy and safety of VX-210 in subjects with Acute Traumatic Cervical Spinal Cord Injury, and whether VX-210 is effective in Neurological re...

Systemic Hypothermia in Acute Cervical Spinal Cord Injury

This study is a prospective multi-center trial designed to determine the safety profile and efficacy of modest (33ºC) intravascular hypothermia following acute cervical (C1 to C8) Spinal ...

A Safety Study for Cethrin (BA-210) in the Treatment of Acute Thoracic and Cervical Spinal Cord Injuries

This trial is a multi-center, open-label, dose-escalation study designed to evaluate the safety, tolerability and pharmacokinetics of Cethrin in two types of spinal cord injury patients: t...

Dose Escalation Study of AST-OPC1 in Spinal Cord Injury

The purpose of this study is to evaluate the safety of 3 sequential escalating doses of AST-OPC1 administered at a single time-point between 14 and 30 days post injury, inclusively, to sub...

Association of Quantitative and Functional Imaging With Clinical Outcome After Spinal Cord Injury

The overall study aim is to provide additional magnetic resonance imaging parameters of the cervical spinal cord, brainstem and brain and a better understanding of changes after spinal cor...

PubMed Articles [7657 Associated PubMed Articles listed on BioPortfolio]

Susceptibility of Cervical Spinal Stenosis to Hypoxic Ischemic Cord Injury.

The adult spinal cord is typically resistant to hypoxic ischemic injury (HII) because of collateral blood supply; however, congenital or acquired stenosis may result in baseline maximal vasodilatation...

Time of Surgery in the Outcome of Cervical Spinal Cord Injury: the University of Puerto Rico Experience.

The purpose of this study was to determine the effect of the timing of surgery on the neurological function of patients with a cervical spinal cord injury.

Novel Nerve Transfers for Motor and Sensory Restoration in High Cervical Spinal Cord Injury: Report of 2 Cases.

Tetraplegia caused by cervical spinal cord injury is devastating for patients and represents a significant public health problem in both developed and developing countries. Improved functional outcome...

Iatrogenic spinal cord injury with tetraplegia after an elective non-spine surgery with underlying undiagnosed cervical spondylotic myelopathy: Literature review and case report.

Cervical spondylotic myelopathy (CSM) can predispose to acute spinal cord injury and post-operative quadriparesis during non-spine procedures, although few accounts of this phenomenon exist within the...

Mid-cervical interneuron networks following high cervical spinal cord injury.

Spinal interneuron (IN) networks can facilitate respiratory motor recovery after spinal cord injury (SCI). We hypothesized that excitatory synaptic connectivity between INs located immediately caudal ...

Medical and Biotech [MESH] Definitions

A syndrome associated with traumatic injury to the cervical or upper thoracic regions of the spinal cord characterized by weakness in the arms with relative sparing of the legs and variable sensory loss. This condition is associated with ischemia, hemorrhage, or necrosis involving the central portions of the spinal cord. Corticospinal fibers destined for the legs are spared due to their more external location in the spinal cord. This clinical pattern may emerge during recovery from spinal shock. Deficits may be transient or permanent.

Repair of the damaged neuron function after SPINAL CORD INJURY or SPINAL CORD DISEASES.

A network of nerve fibers originating in the upper four cervical spinal cord segments. The cervical plexus distributes cutaneous nerves to parts of the neck, shoulders, and back of the head, and motor fibers to muscles of the cervical spinal column, infrahyoid muscles, and the diaphragm.

The segment of the spinal cord within the CERVICAL VERTEBRAE.

Longitudinal cavities in the spinal cord, most often in the cervical region, which may extend for multiple spinal levels. The cavities are lined by dense, gliogenous tissue and may be associated with SPINAL CORD NEOPLASMS; spinal cord traumatic injuries; and vascular malformations. Syringomyelia is marked clinically by pain and PARESTHESIA, muscular atrophy of the hands, and analgesia with thermoanesthesia of the hands and arms, but with the tactile sense preserved (sensory dissociation). Lower extremity spasticity and incontinence may also develop. (From Adams et al., Principles of Neurology, 6th ed, p1269)

More From BioPortfolio on "Randomized Controlled Study on T-PEP Versus IPV Method for Lower Respiratory Airways Clearance in Tetraplegic Tracheotomized Spinal Cord Injured Patients"

Quick Search

Relevant Topics

Spinal Cord Disorders
The spinal cord is a bundle of nerves that runs down the middle of the back which carry signals back and forth between the body and brain. It is protected by vertebrae, which are the bone disks that make up the spine. An accident that damages the verte...

Asthma COPD Cystic Fibrosis Pneumonia Pulmonary Medicine Respiratory Respiratory tract infections (RTIs) are any infection of the sinuses, throat, airways or lungs.  They're usually caused by viruses, but they can also ...

Palliative Care
Palliative care is the active holistic care of patients with advanced progressive illness. Management of pain and other symptoms and provision of psychological, social and spiritual support is paramount. The goal of palliative care is achievement of the ...

Searches Linking to this Trial