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Procedure

Protocolized protective mechanical ventilation in prone position for Lung Transplant (P-POD Trial)

N/A

Waitlist Available

Research Sponsored by Lorenzo delSorbo

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age ≥ 18 years

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 90 days

Awards & highlights

P-POD Trial Summary

This trial aims to investigate whether positioning neurologically deceased lung donors on their stomach (prone position) instead of their back (supine position) can improve lung function and reduce complications. The ultimate

Who is the study for?

This trial is for brain-dead individuals who are potential lung donors. It aims to see if laying them on their stomachs (prone position) instead of their backs can improve the quality of lungs for transplant.Check my eligibility

What is being tested?

The study tests a method called protocolized protective mechanical ventilation in prone position, comparing it with traditional back-lying (supine) positioning to see which is better for preserving donor lung function.See study design

What are the potential side effects?

Since this trial involves individuals who are neurologically deceased, there are no side effects experienced by the participants. The focus is on improving outcomes for lung transplant recipients.

P-POD Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 years old or older.

P-POD Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 90 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~90 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 90 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

This pilot randomized controlled trial will assess the feasibility of conducting a future full randomized clinical trial, specifically, to determine whether donor accrual will be adequate (if we recruit 40 donors from 4 sites over 1 year)

To document adherence to the explicit prone positioning and mechanical ventilation protocol (if more than 80% of donors have no major protocol violations then considered adequate)

To document the number of those who cross over to the alternate strategy (if fewer than 10% of donors cross over to the alternate strategy, when not allowed by protocol then considered adequate)

P-POD Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Protocolized protective mechanical ventilation in prone positionExperimental Treatment1 Intervention

Group II: Protocolized protective mechanical ventilation in supine positionActive Control1 Intervention

0 / 1Eligibility criteria met

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Who is running the clinical trial?

Lorenzo delSorboLead Sponsor

1 Previous Clinical Trials

299 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are researchers currently enrolling participants for this medical study?

"As per the details on clinicaltrials.gov, recruitment for this clinical trial is presently closed. The initial posting date was 4/1/2024 with the most recent update made on 2/6/2024. Despite this trial not accepting candidates currently, there are a total of 83 other ongoing studies actively seeking participants."

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Recent research and studies

clinicaltrials.govStudy

Prone Positioning in Neurologically Deceased Potential Organ Donors to Improve Donor Lung Function and Lung Transplant Recipient Outcomes

Lorenzo delSorbo 2024. "Prone Positioning in Neurologically Deceased Potential Organ Donors to Improve Donor Lung Function and Lung Transplant Recipient Outcomes". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06259357.