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

NCT04142814 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2022-04-28

No results posted yet for this study

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.

Conditions

  • Spinal Cord Injury Cervical

Interventions

PROCEDURE

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.

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.

Sponsors & Collaborators

  • Montecatone Rehabilitation Institute S.p.A.

    lead OTHER

Principal Investigators

  • Carlotta Stopazzoni, MD · Montecatone Rehanilitation Institute SpA

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-28
Primary Completion
2023-07-31
Completion
2023-08-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04142814 on ClinicalTrials.gov