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NCT Number: NCT04164173

Hyperinflation Respiratory Therapies in Cardiac Surgery Patients

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UT Southwestern Clements University Hospital

Dallas, Texas, 75390, United States

Location status: Recruiting

Location contact

Cheryl Mansir, RT

CONTACT

[email protected]

214/633-4791

Gabriel Rodriguez, RT

CONTACT

[email protected]

214/633-4791

About this study

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.

  • 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.
  • The EzPAP is another respiratory treatment and participants will breath against to resistance in order to prolong the time the lung remain open.
  • 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:

  • Over distention of air sucks (alveoli). Sometimes pressure trauma in your lung may cause pneumothorax.
  • Infection
  • Bloody sputum (hemoptysis)
  • Blood gas changes such as decrease carbon dioxide or increase oxygen in your blood.
  • Sometimes stomach may distend
  • Impaction of airway secretions if gas mixture not humidified enough.
  • Your blood return to the heart maybe decreased which may affect your blood pressure.
  • Exacerbation of low blood oxygen level (hypoxemia),
  • Decreased or increased respiration
  • Air trapping in your airway
  • You may psychologically dependence to device

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18 years and older
  • Admitted to Cardiovascular ICU (CVICU) after coronary artery bypass grafting (CABG), isolated valve repair/replacement, or CABG + valve repair/replacement
  • Cardiac surgery performed via median sternotomy

Exclusion criteria

  • BMI>40
  • Refusal to be consented
  • Prior or current lung transplant patients

Treatment and study plan

EzPAP

Device

Patient will receive 10 min EzPAP 4 times daily

Other names: Postoperative hyperinflation therapy-EzPAP

MetaNeb

Device

Patient will receive 10 min Metaneb 4 times daily

Other names: Postoperative hyperinflation therapy-Metaneb

Intermittent Positive Pressure Breathing (IPPB)

Device

Patient will receive 10 min IPPB 4 times daily

Other names: Postoperative hyperinflation therapy-IPPB

Primary outcomes

  1. Postoperative lung function as assessed by the changes in FEV1/FVC

    Time frame: Up to 96 hours postoperatively or until discharge from the intensive care unit (ICU), whichever came first.

    The postoperative changes in the Forced Expiratory Volume in one second (FEV1)/the Forced Vital Capacity (FVC) in microspirometry

Study contacts

Contact information is provided by the study sponsor or research team.

Emily Melikman, RN

CONTACT

[email protected]

214-645-7011

Jaffer Odeh, MD

CONTACT

[email protected]

214-786-1067

Sponsors and collaborators

Lead sponsor

University of Texas Southwestern Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2028
Study completion
2028
First posted
Nov 15, 2019
Registry last updated
Nov 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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