Hyperinflation Respiratory Therapies in Cardiac Surgery Patients

Postoperative Complications Clinical Trial

Official title:

Hyperinflation Respiratory Therapies in Cardiac Surgery Patients: A Randomized, Observer-Blinded, Prospective Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04164173
• Other study ID #: STU-2019-1242
• Status: Recruiting
• Phase: N/A
• Start date: June 15, 2020
• Est. completion date: December 31, 2024

Study information

• Verified date: February 2024
• Source: University of Texas Southwestern Medical Center
• Contact: Jaffer Odeh, MD
• Phone: 214-786-1067
• Email: Jaffer.Odeh[@]UTSouthwestern.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this prospective randomized clinical trial is to evaluate three different types of hyperinflation respiratory therapies, Intermittent Positive Pressure Breathing (IPPB), Intermittent positive end expiratory pressure (EzPAP), Metaneb. Investigators will examine which hyperinflation therapy provides better lung expansion and may improve lung recovery after surgery.

Description:

Postoperative pain due to surgical incision may limit lung expansion. After cardiac surgery, all patients receive respiratory therapies, because it is critical to expand lung after surgery to prevent respiratory complications such as lung collapse (atelectasis) due to shallow breathing or accumulation of airway secretions. Although incentive spirometer is the most common method used for lung recovery after cardiac surgery, some studies were not able to find any benefits from the use of incentive spirometer. Inspiratory positive-pressure breathing (IPPB), Intermittent positive end expiratory pressure (EzPAP), and chest airway clearance (Metaneb) are hyperinflation therapies used after surgery. The purpose of this research study is to determine which hyperinflation respiratory therapy provide better lung recovery after cardiac surgery. Hyperinflation Respiratory Therapies:Participants will be randomly assigned one of the hyperinflation respiratory therapy, intermittent positive pressure breathing (IPPB) and the EzPAP or the Metaneb. 1. Intermittent positive pressure breathing (IPPB) is a respiratory therapy technique which will support your breathing by providing pressure support. This respiratory method will increase air volume breathing in. 2. The EzPAP is another respiratory treatment and participants will breath against to resistance in order to prolong the time the lung remain open. 3. The Metaneb will provide resistance when patients breathing in order to prolong the lung opening. Hyperinflation therapy will be performed every 4 hours in the intensive care unit (ICU). Each respiratory therapy session will take about 15 minutes. Participants' pulmonary function will be evaluated daily to monitor the lung recovery with microspirometer which will take place approximately 5 minutes. Total study duration is about 96 hours after surgery or until discharge from the Intensive Care Unit. Risk for Lung over expansion (hyperinflation) therapy: Hyperinflation respiratory treatments target to expand your lung to prevent complication such as collapse of small airway after surgery. This over expansion of your lung may increase work of breathing. All expected complications are typical in the post-operative cardiac patients and not unique to hyperinflation therapy. The possible complications listed below: 1. Over distention of air sucks (alveoli). Sometimes pressure trauma in your lung may cause pneumothorax. 2. Infection 3. Bloody sputum (hemoptysis) 4. Blood gas changes such as decrease carbon dioxide or increase oxygen in your blood. 5. Sometimes stomach may distend 6. Impaction of airway secretions if gas mixture not humidified enough. 7. Your blood return to the heart maybe decreased which may affect your blood pressure. 8. Exacerbation of low blood oxygen level (hypoxemia), 9. Decreased or increased respiration 10. Air trapping in your airway 11. You may psychologically dependence to device

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 324
• Est. completion date: December 31, 2024
• Est. primary completion date: August 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Age 18 years and older

2. Admitted to Cardiovascular ICU (CVICU) after coronary artery bypass grafting (CABG), isolated valve repair/replacement, or CABG + valve repair/replacement

3. Cardiac surgery performed via median sternotomy

Exclusion Criteria:

1. BMI>40

2. Refusal to be consented

3. Prior or current lung transplant patients

Related Conditions & MeSH terms

• Postoperative Complications
• Pulmonary Disease

Intervention

Device:
• EzPAP
Patient will receive 10 min EzPAP 4 times daily
• Metaneb
Patient will receive 10 min Metaneb 4 times daily
• Intermittent Positive Pressure Breathing (IPPB)
Patient will receive 10 min IPPB 4 times daily

Locations

Country	Name	City	State
United States	UT Southwestern Clements University Hospital	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative lung function as assessed by the changes in FEV1/FVC	The postoperative changes in the Forced Expiratory Volume in one second (FEV1)/the Forced Vital Capacity (FVC) in microspirometry	Up to 96 hours postoperatively or until discharge from the intensive care unit (ICU), whichever came first.