Pulmonary Expansion Device in Tracheostomized Patients Therapies in Tracheostomized Patients

Launched by FUNDACION CLINICA VALLE DEL LILI · Oct 3, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new device called the Pulmonary Expansion Device (PED) to see if it can help patients with a tracheostomy breathe better after surgery. The main aim is to find out if using the PED alongside standard care can improve oxygen levels and lung function while reducing complications after surgery, compared to using standard care alone.

To participate in this trial, you need to be at least 18 years old and have a tracheostomy tube that is working properly. You should also be breathing on your own for more than 24 hours and need help with lung expansion after certain surgeries or injuries. However, there are some conditions that would prevent you from joining, like severe breathing difficulties or certain heart and lung issues. If you take part, you can expect to receive either the new device treatment with standard care or just standard care alone, and the researchers will monitor your progress to see how well you respond. This trial is currently not recruiting participants, so it will start accepting volunteers soon.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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).