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

NCT ID: NCT04142814

Last Updated: 2022-04-28

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-28
• Study Completion Date: 2023-08-31

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.

Conditions

Spinal Cord Injury Cervical

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

T-PEP

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.

Group Type: EXPERIMENTAL

T-PEP

Intervention Type: PROCEDURE

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.

IPV

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.

Group Type: ACTIVE_COMPARATOR

IPV

Intervention Type: PROCEDURE

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.

Interventions

T-PEP

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.

Intervention Type: PROCEDURE

IPV

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.

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Montecatone Rehabilitation Institute S.p.A.

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Carlotta Stopazzoni, MD

Role: PRINCIPAL_INVESTIGATOR

Montecatone Rehanilitation Institute SpA

Locations

Montecatone Rehabilitation Institute S.p.A.

Imola, BO, Italy

Countries

Italy

Other Identifiers

CE-378/2018/SPER/AUSLIM

Identifier Type: -

Identifier Source: org_study_id