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

NCT04142814 | Withdrawn

• 1 other identifier: CE-378/2018/SPER/AUSLIM
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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

  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 (16)

• Time needed for attainment of a stabilized effective pulmonary ventilation

  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

  From the attainment of stabilized effective pulmonary ventilation until 3 months later

• Incidence of infections of lower respiratory airways

  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

  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

• Time needed for weaning from mechanical ventilation, from its start

  From mechanical ventilation start date until mechanical ventilation end date (up to 1 year)

Study Arms (2)

T-PEP

EXPERIMENTAL

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.

Procedure: T-PEP

IPV

ACTIVE COMPARATOR

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.

Procedure: IPV

Interventions

T-PEP 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.

T-PEP

IPV 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.

IPV

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Montecatone Rehabilitation Institute S.p.A.: lead

Study Sites (1)

Montecatone Rehabilitation Institute S.p.A.

Imola, BO, 40026, Italy

Location

MeSH Terms

Conditions

Quadriplegia

Condition Hierarchy (Ancestors)

Paralysis; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Carlotta Stopazzoni, MD

  Montecatone Rehanilitation Institute SpA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2019
• First Posted: October 29, 2019
• Study Start: February 1, 2022
• Primary Completion: July 1, 2023
• Study Completion: August 1, 2023
• Last Updated: April 28, 2022

Record last verified: 2022-04

Locations

IT (1)