Status:
UNKNOWN
Pulmonary Expansion Device in Tracheostomized Patients Therapies in Tracheostomized Patients
Lead Sponsor:
Fundacion Clinica Valle del Lili
Conditions:
Postoperative Complications
Rehabilitation
Eligibility:
All Genders
18-99 years
Phase:
PHASE2
Brief Summary
The goal of this clinical trial is to evaluate the safety and efficacy of using PED (Pulmonary Expansion Device) in tracheostomized patients requiring lung reexpansion therapy within a single institut...
Detailed Description
Sample size: Considering that the utilization of the PED introduces an innovative approach to the standard postoperative care of tracheostomized patients, who inherently face an elevated risk of pulmo...
Eligibility Criteria
Inclusion
- Adults aged 18 and older.
- Patients with a tracheostomy tube equipped with a functional cuff.
- Patients exhibiting spontaneous breathing for a period exceeding 24 hours.
- Patients requiring lung reexpansion techniques (Postoperative period following thoracic or high abdominal surgery, thoracic trauma, rib fracture, among others).
- Chest imaging confirming the absence of pulmonary parenchyma alterations.
Exclusion
- Presence of signs of respiratory distress.
- Alteration in consciousness and loss of decision-making autonomy.
- Cervical spinal cord injury up to T1.
- Muscular weakness due to neuro-demyelinating or peripheral nerve disease.
- Complete dependence on ventilatory support.
- Intracranial pressure greater than 20 mmHg.
- Poorly controlled pain with a Visual Analog Scale (VAS) score of 5 or more.
- Presence of nausea or vomiting.
- Active hemoptysis.
- Pulmonary edema.
- Decompensated congestive heart failure New York Heart Association (NYHA) III-IV.
- Severe physical deconditioning.
- Chronic Obstructive Pulmonary Disease (COPD) Gold E.
- Patients for whom lung reexpansion techniques are contraindicated (pulmonary bullae, pulmonary fistulas, unresolved pneumothorax or hemothorax, medically managed primary spontaneous pneumothorax, platelet count \<50,000, among others).
Key Trial Info
Start Date :
February 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2025
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06075381
Start Date
February 1 2024
End Date
November 1 2025
Last Update
October 10 2023
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