Clinical trial NCT04142814: Randomized Controlled Study on T-PEP Versus IPV Method for Lower Respiratory Airways Clearance in Tetraplegic Tracheotomized Spinal Cord Injured Patients
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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
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
Mechanical ventilation
Respiratory physiotherapy
Lead sponsor: Montecatone Rehabilitation Institute S.p.A.
Sponsor class: OTHER
First posted: 2019-10-29
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of adverse events
timeFrame: 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:
measure: Time needed for attainment of a stabilized effective pulmonary ventilation
timeFrame: Through the whole period of clearance treatment to attain a stabilized effective pulmonary ventilation (whole period length is 2 weeks on average)
measure: Recurrence of lower airways obstruction
timeFrame: From the attainment of stabilized effective pulmonary ventilation until 3 months later
measure: Incidence of infections of lower respiratory airways
timeFrame: 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
measure: Incidence of sepsis
timeFrame: 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
measure: Time needed for weaning from mechanical ventilation, from its start
timeFrame: From mechanical ventilation start date until mechanical ventilation end date (up to 1 year)
measure: Time needed for weaning from mechanical ventilation, from hospital admission
timeFrame: From admission date to Montecatone R.I. until mechanical ventilation end date (up to 1 year)
measure: Evaluation of cognitive performance: attention and memory - 1
timeFrame: 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
measure: Evaluation of cognitive performance: attention and memory - 2
timeFrame: 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
measure: Evaluation of cognitive performance: attention and memory - 3
timeFrame: 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
measure: Evaluation of cognitive performance: attention and memory - 4
timeFrame: 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
measure: Evaluation of cognitive performance: logical and executive functions - 1
timeFrame: 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
measure: Evaluation of cognitive performance: logical and executive functions - 2
timeFrame: 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
measure: Evaluation of cognitive performance: logical and executive functions - 3
timeFrame: 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
measure: Evaluation of cognitive performance: social cognition
timeFrame: 3 months after the day of attainment of stabilized effective pulmonary ventilation
measure: Costs of the T-PEP and IPV treatments - 1
timeFrame: Through the whole period of clearance treatment to attain a stabilized effective pulmonary ventilation (whole period length is 2 weeks on average)
measure: Costs of the T-PEP and IPV treatments - 2
timeFrame: Through the whole period of clearance treatment to attain a stabilized effective pulmonary ventilation (whole period length is 2 weeks on average)
Other outcomes:
Locations:
city: Imola
country: Italy
facility: Montecatone Rehabilitation Institute S.p.A.
state: BO
Study officials:
affiliation: Montecatone Rehanilitation Institute SpA
name: Carlotta Stopazzoni, MD
role: PRINCIPAL_INVESTIGATOR
References: