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

Montecatone Rehabilitation Institute S.p.A.

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Conditions

Spinal Cord Injury Cervical

Interventions

T-PEPPROCEDURE

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

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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; * patients in partial or continuous mechanical ventilation; * patients with tracheotomy; * patients capable of giving meaningful consent; * collaborating patients. Exclusion Criteria: * 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.

Locations (1)

Montecatone Rehabilitation Institute S.p.A.

Imola, BO, Italy

Outcomes

Primary Outcomes

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

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

Secondary Outcomes

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.

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

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

Time frame: 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.

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

Incidence of sepsis related to acute infections of the lower respiratory airways, throughout the study period

Data from ClinicalTrials.gov

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