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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine which of three breathing therapies—EzPAP, Metaneb, or Intermittent Positive Pressure Breathing (IPPB)—best aids lung recovery after surgery. These therapies help expand the lungs and may improve breathing following heart surgeries such as bypass or valve repairs. Patients recovering in a cardiovascular ICU after heart surgery through the chest might be suitable candidates.

As an unphased trial, this study provides patients the chance to contribute to important research that could improve recovery options after heart surgery.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the EzPAP device, which helps keep airways open, is generally easy for most people to use. One study found that it can make breathing easier, suggesting it's safe for most users. However, like any device, it might carry some risks, though these are not often reported.

For Metaneb, studies have shown it is well-tolerated and often preferred by patients over other similar treatments. It has been used safely in patients who have undergone major surgery, indicating it is generally safe.

Intermittent Positive Pressure Breathing (IPPB) carries some rare risks, such as infection or lung collapse, but these are uncommon. Overall, IPPB helps keep lungs open and improves breathing after surgery, and many people handle it well.

In summary, current research generally considers all three treatments safe. However, as with any medical treatment, there can be risks. It's important to discuss these with healthcare providers before starting therapy. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these respiratory therapies because they offer innovative ways to aid lung recovery after surgery. Unlike traditional methods like incentive spirometry, EzPAP uses a unique approach by delivering positive air pressure during exhalation, helping to keep airways open and improve ventilation. Metaneb combines continuous positive airway pressure with oscillation, which may enhance mucus clearance more effectively. Additionally, Intermittent Positive Pressure Breathing (IPPB) provides periodic boosts of air, potentially improving lung expansion and gas exchange. These techniques could provide quicker and more effective postoperative lung recovery compared to existing options.

What evidence suggests that this trial's treatments could be effective for postoperative lung recovery?

This trial will compare different postoperative respiratory therapies. Studies have shown that EzPAP therapy, one treatment participants may receive, effectively improves oxygen levels after surgery by helping the lungs expand, making breathing easier. Another treatment option, Metaneb therapy, uses gentle air pressure, and research indicates it can reduce lung problems and shorten hospital stays after surgery. Additionally, some participants will receive IPPB, which has been found to increase the depth of breathing, though it might not be more effective than simply encouraging deeper breaths. Overall, these therapies aim to help lungs recover faster by providing extra support for better breathing after surgery. ^{1 4 6 7 8}

Who Is on the Research Team?

Jaffer Odeh, MD

Principal Investigator

UT Southwestern Medical Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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) 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]

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]

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]

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]

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) 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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/23011043/

[EzPAP® therapy of postoperative hypoxemia in the ... The EzPAP® system represents a well-tolerated, effective, cost-effective and easily operated tool to improve postoperative oxygenation.

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0954611125004469

EzPAP therapy versus non-invasive ventilation for ... In our study, we found that EzPAP significantly improved oxygen saturation and alleviated respiratory acidosis more rapidly than NIV in participants with mild ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT02262182

Interest of Positive Expiratory Pressure (PEP) Delivery by ... Our objective is to evaluate the interest of association of positive end expiratory delivery sessions with the EzPAP® device.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12220370/

Comparison of positive expiratory pressure device versus ... These findings suggest that EzPAP® may be effective in improving lung volumes in COPD. However, since standardization of spirometry in emergency ...

5. withpower.com withpower.com/trial/phase-postoperative-complications-5-2020-c9661

Respiratory Therapies for Postoperative Lung Recovery The treatment combines different positive pressure techniques like EzPAP and IPPB, which help expand the lungs and improve breathing after surgery. This ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9198711/

Positive end-expiratory pressure and risk of postoperative ... The primary outcome was a composite of PPCs within the first 7 postoperative days. The secondary outcomes included reintubation and unplanned ...

7. researchgate.net researchgate.net/publication/270729779_P68_A_study_to_investigate_the_clinical_use_and_outcomes_of_EZPAP_positive_pressure_device

P68 A study to investigate the clinical use and outcomes of ... Additionally, this study yielded results to suggest that EZPAP also reduces the work of breathing with a mean decrease of respiratory rate of ...

8. jtcvs.org jtcvs.org/article/S0022-5223(19)39689-8/pdf

Postoperative intermittent positive-pressure breathing ... positive end-respiratory pressure is effective in patients with stiff lungs, marked shunting, and poor respiratory compliance. It is safe to use muscle ...