Hyperinflation Respiratory Therapies in Cardiac Surgery Patients

NCT ID: NCT04164173

Last Updated: 2025-11-04

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 324 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-15
• Study Completion Date: 2028-12-31

Brief 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.

Detailed 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

Conditions

Pulmonary Disease; Postoperative Complications

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

EzPAP

The patient will have EzPAP postoperative respiratory therapy as 3 x 10 breaths at a 1:4 ratio four times daily

Group Type: EXPERIMENTAL

EzPAP

Intervention Type: DEVICE

Patient will receive 10 min EzPAP 4 times daily

Metaneb

The patient will have Metaneb postoperative respiratory therapy as 10 minutes Continuous Positive End Expiratory Pressure (CPEP) four times daily

Group Type: EXPERIMENTAL

Metaneb

Intervention Type: DEVICE

Patient will receive 10 min Metaneb 4 times daily

Intermittent Positive Pressure Breathing (IPPB)

The patient will have Intermittent positive pressure breathing (IPPB) postoperatively for 10 minutes four times daily

Group Type: EXPERIMENTAL

Intermittent Positive Pressure Breathing (IPPB)

Intervention Type: DEVICE

Patient will receive 10 min IPPB 4 times daily

Interventions

EzPAP

Patient will receive 10 min EzPAP 4 times daily

Intervention Type: DEVICE

Metaneb

Patient will receive 10 min Metaneb 4 times daily

Intervention Type: DEVICE

Intermittent Positive Pressure Breathing (IPPB)

Patient will receive 10 min IPPB 4 times daily

Intervention Type: DEVICE

Other Intervention Names

Postoperative hyperinflation therapy-EzPAP; Postoperative hyperinflation therapy-Metaneb; Postoperative hyperinflation therapy-IPPB

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Texas Southwestern Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Jaffer Odeh

Assistant Profesor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jaffer Odeh, MD

Role: STUDY_CHAIR

UT Southwestern Medical Center

Locations

UT Southwestern Clements University Hospital

Dallas, Texas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Jaffer Odeh, MD

Role: CONTACT

Jaffer.Odeh@UTSouthwestern.edu

214-786-1067

Emily Melikman, RN

Role: CONTACT

Emily.Melikman@UTSouthwestern.edu

214-645-7011

Facility Contacts

Cheryl Mansir, RT

Role: primary

Cheryl.Mansir@UTSouthwestern.edu

214/633-4791

Gabriel Rodriguez, RT

Role: backup

Gabriel.Rodriguez@utsouthwestern.edu

214/633-4791

Other Identifiers

STU-2019-1242

Identifier Type: -

Identifier Source: org_study_id