Pulmonary Expansion Device in Tracheostomized Patients Therapies in Tracheostomized Patients

PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

February 29, 2024

Primary Completion Date

June 30, 2025

Study Completion Date

November 30, 2025

Conditions
Postoperative ComplicationsRehabilitationPostoperative Care
Interventions
COMBINATION_PRODUCT

Pulmonary Expansion Device (PED)

The Pulmonary Expansion Device constitutes an innovative instrumental technique for lung expansion, designed for use in patients with or without an artificial airway. This device is attached to the artificial airway, the oronasal mask, or the patient's mouth. It enables voluntary control through a system of one-way valves that restrict the air's escape from the lungs to the outside. This creates an environment conducive to retaining air within the lungs, thereby increasing intrapulmonary pressure. Additionally, it reduces the risk of pulmonary complications associated with conventional management, employing a strategy free from exogenous application of positive pressure to the airway. This approach doesn't necessitate expensive equipment or electrical power.

PROCEDURE

Conventional management

The conventional management includes: Adequate postoperative pain control, global postural reeducation, reeducation of breathing pattern, airway hygiene, early mobilization, respiratory and scapular waist exercises, and in patients with evidence of lung atelectasis or mild persistent hypoxemia, conventional management will involve the use of intermittent positive pressure ventilation in the airway.

All Listed Sponsors
lead

Fundacion Clinica Valle del Lili

OTHER