Respiratory Therapies for Postoperative Lung Recovery

Overseen By Jaffer Odeh, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Texas Southwestern Medical Center

Disqualifiers: Bmi>40, Lung transplant, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 96 hours or until discharge from ICU

324 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment EzPAP, Intermittent Positive Pressure Breathing (IPPB), and MetaNeb for postoperative lung recovery?

The research suggests that while intermittent positive pressure breathing (IPPB) has limited benefits for preventing postoperative lung problems, it may be useful in severe asthma cases that don't respond to other treatments. However, its effectiveness for general postoperative lung recovery remains uncertain, and further studies are needed to improve these methods. ^{1 2 3 4 5}

Is the treatment generally safe for humans?

Intermittent Positive Pressure Breathing (IPPB) therapy has some rare risks, such as infection, lung collapse (pneumothorax), and reduced heart function, which could extend hospital stays. However, these risks are uncommon, and the treatment is generally considered safe for most patients. ^{2 3 4 6 7}

How is the treatment for postoperative lung recovery unique?

The treatment combines different positive pressure techniques like EzPAP and IPPB, which help expand the lungs and improve breathing after surgery. This approach is unique because it uses a combination of methods to enhance lung function and reduce complications, unlike standard treatments that may focus on a single method. ^{3 4 5 8 9}

What is the purpose of this trial?

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.

Research Team

Jaffer Odeh, MD

Principal Investigator

UT Southwestern Medical Center

Eligibility Criteria

This trial is for adults over 18 who are in the Cardiovascular ICU after certain heart surgeries like bypass or valve repair. They must have had their surgery through a cut down the middle of the chest. It's not for those with a BMI over 40, those who don't consent to participate, or patients with past or current lung transplants.

Inclusion Criteria

I had heart surgery through a cut down the center of my chest.

I was admitted to the CVICU after heart surgery.

Exclusion Criteria

I have had a lung transplant.

I do not agree to participate in this study.

My BMI is over 40.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive hyperinflation respiratory therapies (IPPB, EzPAP, or Metaneb) every 4 hours in the ICU for lung recovery after cardiac surgery

96 hours or until discharge from ICU

Continuous monitoring in ICU

Follow-up

Participants are monitored for safety and effectiveness after treatment

1-2 weeks

Treatment Details

Interventions

• EzPAP
• Intermittent Positive Pressure Breathing (IPPB)
• Metaneb

Trial Overview The study is comparing three breathing treatments—IPPB, EzPAP, and Metaneb—to see which one helps lungs recover better after heart surgery. Patients will be randomly assigned to receive one of these therapies as they recuperate.

Participant Groups

Group I: Metaneb Experimental Treatment 1 Intervention

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

Group II: Intermittent Positive Pressure Breathing (IPPB) Experimental Treatment 1 Intervention

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

Group III: EzPAP Experimental Treatment 1 Intervention

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

EzPAP is already approved in United States for the following indications:

Approved in United States as EzPAP for:

• Mobilization of secretions
• Lung expansion therapy
• Treatment and prevention of pulmonary atelectasis

Who Is Running the Clinical Trial?

University of Texas Southwestern Medical Center

Lead Sponsor

Trials

1,102

Recruited

1,077,000+

Findings from Research

Intermittent positive pressure breathing (IPPB) has been a controversial treatment for asthma, but it may be beneficial for severe cases that do not respond to standard beta-agonist inhalation methods.

Despite its potential benefits, IPPB carries risks such as pulmonary infection and pneumothorax, highlighting the need for careful consideration before use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intermittent positive pressure breathing and the treatment of acute asthma. Eggertsen, SC.[2004]

Intermittent positive pressure breathing (IPPB) is an expensive therapy that uses positive-pressure ventilation to deliver medication to the lungs, but it has been found to offer no significant advantages over cheaper and safer alternatives like nebulizers or metered-dose inhalers for most patients with obstructive airway diseases.

While IPPB can be beneficial for severely ill patients with weak respiratory muscles, it carries risks such as infection and pneumothorax, which could lead to longer hospital stays, making its cost-effectiveness questionable.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Review of the status of intermittent positive pressure breathing therapy. Gonzalez, ER., Burke, TG.[2019]

Mechanical insufflation-exsufflation (MI-E) therapy resulted in better pulmonary function outcomes, such as higher force vital capacity and forced expiratory volume, compared to intermittent positive pressure breathing (IPPB) therapy in cardiac surgery patients.

Despite the improved lung function with MI-E, it was associated with a higher incidence of chest pain compared to IPPB, indicating a potential trade-off between efficacy and discomfort.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of mechanical insufflation-exsufflation on lung function and complications in cardiac surgery patients: a pilot study. Wu, MF., Wang, TY., Chen, DS., et al.[2021]

Intermittent positive pressure breathing combined with therapeutic aerosol inhalation (IPPB/I) did not show significant improvements in respiratory function or prevent postoperative pulmonary complications in patients with carcinoma after 7 days of treatment.

In fact, there was a notable decrease in arterial PO2 immediately following the IPPB/I treatment, indicating that further research is needed to enhance the effectiveness of this method.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Prophylactic and therapeutic intermittent positive pressure breathing with combined therapeutic aerosols (IPPB/I)--functional and morphological effects. I. Functional effects of prophylactic IPPB/I (author's transl)]. Kleinau, H., Scholz, V.[2013]

Intermittent positive-pressure breathing (IPPB) has limited effectiveness and is not recommended for preventing postoperative pulmonary issues like pneumonia or atelectasis.

IPPB does not provide significant benefits over voluntary hyperventilation or deep breathing for delivering aerosol medications or treating stable chronic obstructive pulmonary disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intermittent positive-pressure breathing. A critical appraisal. Fouts, JB., Brashear, RE.[2019]

Two patients experienced acute alveolar hypoventilation after receiving Intermittent Positive Pressure Breathing (IPPB) therapy, suggesting a potential safety concern with this treatment.

The hypoventilation may have been caused by respiratory center depression due to excessive oxygen administration, as switching to compressed air during therapy revealed this complication in one patient.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Insidious onset of acute alveolar hypoventilation following intermittent positive-pressure breathing (IPPB). Israel, RH., Poe, RH.[2018]

A controlled trial is currently underway to evaluate the efficacy of home Intermittent Positive Pressure Breathing (IPPB) therapy in patients with chronic airflow obstruction, specifically those with chronic hypercapnia (high carbon dioxide levels in the blood).

Patients will be randomly assigned to receive either IPPB therapy or standard care for at least 1 to 2 hours daily over a 2-year period, with evaluations based on five predetermined criteria to assess treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[A control trial of home I.P.P.B. therapy in patients with chronic obstructive respiratory insufficiency. Protocol and state of the study (author's transl)]. Kompalitch, M., Brille, D., Diaz, M., et al.[2013]

Intermittent positive pressure breathing (IPPB) is not supported for postoperative prophylaxis, but it can be beneficial in the acute phase for patients with low lung volumes due to neuromuscular diseases or spinal injuries, improving tidal volume and cough effectiveness.

Continuous positive airway pressure (CPAP) is well-documented for improving lung volumes and is used by physiotherapists as a second-line treatment for patients with low lung volumes after surgery, particularly in cases of refractory atelectasis and poor gas exchange.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of positive pressure devices by physiotherapists. Denehy, L., Berney, S.[2022]

Postoperative noninvasive positive pressure ventilation (NIPPV) can significantly improve oxygenation and ventilation in high-risk patients who develop respiratory issues after surgery, particularly those with atelectasis or obesity.

If a patient does not respond to NIPPV within 20 minutes, it typically indicates the need for intubation and mechanical ventilation, highlighting the importance of timely intervention in managing postoperative respiratory failure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postoperative noninvasive ventilation. Neligan, PJ.[2012]

References

1. United States pubmed.ncbi.nlm.nih.gov

Intermittent positive pressure breathing and the treatment of acute asthma. [2004]

2. United States pubmed.ncbi.nlm.nih.gov

Review of the status of intermittent positive pressure breathing therapy. [2019]

3. England pubmed.ncbi.nlm.nih.gov

The effects of mechanical insufflation-exsufflation on lung function and complications in cardiac surgery patients: a pilot study. [2021]

4. Germany pubmed.ncbi.nlm.nih.gov

[Prophylactic and therapeutic intermittent positive pressure breathing with combined therapeutic aerosols (IPPB/I)--functional and morphological effects. I. Functional effects of prophylactic IPPB/I (author's transl)]. [2013]

5. England pubmed.ncbi.nlm.nih.gov

Intermittent positive-pressure breathing. A critical appraisal. [2019]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Insidious onset of acute alveolar hypoventilation following intermittent positive-pressure breathing (IPPB). [2018]

7. France pubmed.ncbi.nlm.nih.gov

[A control trial of home I.P.P.B. therapy in patients with chronic obstructive respiratory insufficiency. Protocol and state of the study (author's transl)]. [2013]

8. England pubmed.ncbi.nlm.nih.gov

The use of positive pressure devices by physiotherapists. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Postoperative noninvasive ventilation. [2012]