Pulmonary Expansion Device in Tracheostomized Patients Therapies in Tracheostomized Patients

NCT06075381 | Unknown Phase 2 DMC

• 1 other identifier: 02129
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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 institution. The main question it aims to answer is: In tracheostomized patients requiring lung reexpansion therapy, does the utilization of PED (Pulmonary Expansion Device) alongside conventional management constitute a safe and effective strategy for improving oxygenation, lung volumes, and reducing postoperative pulmonary complications, as compared to traditional management alone? Researchers will compare lung expansion therapy with PED plus conventional management versus lung expansion therapy through conventional management in tracheostomized patients to assess the safety and efficacy in terms of improvement in oxygenation, lung volumes, and reduction of postoperative pulmonary complications.

Conditions

Postoperative Complications; Rehabilitation; Postoperative Care

Keywords

Inspiratory Capacity; Breathing Exercises; Self-help Devices; Inventions

Outcome Measures

Primary Outcomes (1)

• Lung volumes

  Describe the lung volumes through measurements with a Wright respirometer in tracheostomized patients requiring lung reexpansion therapy, where the use of PED plus conventional management is compared to conventional management alone.

  At three different time points: Day one, day three and day six following the removal of invasive ventilatory support

Secondary Outcomes (2)

• Arterial oxygen pressure

  At three different time points: Day one, day three and day six following the removal of invasive ventilatory support

• Postoperative pulmonary complication

  Follow-up throughout hospitalization and up to 28 days from randomization

Study Arms (2)

Conventional management plus Pulmonary Expansion Device (PED)

EXPERIMENTAL

The conventional management used in the intensive care unit as a lung expansion strategy in patients with tracheostomy plus Pulmonary Expansion Device (PED).

Combination Product: Pulmonary Expansion Device (PED); Procedure: Conventional management

Conventional management alone

ACTIVE COMPARATOR

Conventional management employed in the intensive care unit as a lung expansion strategy in tracheostomized patients, without utilizing the Pulmonary Expansion Device (PED).

Procedure: Conventional management

Interventions

Pulmonary Expansion Device (PED) COMBINATION_PRODUCT

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.

Conventional management plus Pulmonary Expansion Device (PED)

Conventional management PROCEDURE

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.

Conventional management alone; Conventional management plus Pulmonary Expansion Device (PED)

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Fundacion Clinica Valle del Lili: lead

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• MAURICIO VELASQUEZ GALVIS

  Fundacion Clinica Valle del Lili

  STUDY CHAIR

Central Study Contacts

ALVARO I SANCHEZ ORTIZ

CONTACT

+57 3183593663; alvaro.sanchez@fvl.org.co

ASTRID C ALVAREZ ORTEGA

CONTACT

+57 3175688544; astrid.alvarez.or@fvl.org.co

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Due to the nature of the intervention, it is not feasible to mask the treatment in the control group and intervention group, although both groups will receive a standard treatment. One group will receive treatment through the use of the PED, while the other group will receive treatment through intermittent positive pressure in cases of lung atelectasis or mild persistent hypoxemia. After obtaining informed consent from eligible participants, the assignment to the therapeutic group will be carried out using a code that does not openly indicate the assigned group. Individuals aware of the assignment will be the physiotherapists administering the interventions and collecting data in the electronic format, which will be isolated from the data analysis. Generating these codes for each patient aims to blind the interventions during the statistical analysis process. All information will be recorded in electronic format.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Controlled, randomized, blinded, parallel-group, Phase II clinical study of applying conventional management plus the use of a lung reexpansion device versus conventional management alone as a lung reexpansion strategy in tracheostomized patients.

Study Record Dates

• First Submitted: October 3, 2023
• First Posted: October 10, 2023
• Study Start: February 1, 2024
• Primary Completion: June 1, 2025
• Study Completion: November 1, 2025
• Last Updated: October 10, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share