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NCT01539135 · ClinicalTrials.gov registry record · NA
The Influence of Endotracheal Tube Design on Fluid Leakage Into the Lungs During Surgery
A NA study, sponsored by Medtronic - MITG.
- Completed
- Registry status
- NA
- Development phase
- 80
- Enrollment target
NCT01539135: Completed NA study, sponsored by Medtronic - MITG.
NCT01539135 is a NA study that has completed, run by Medtronic - MITG. The registered enrollment target is 80 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01539135, a NA study, has completed, sponsored by Medtronic - MITG.
- COMPLETED
- Registry status
- NA
- Development phase
- 80 participants
- Enrollment target
Study Summary
Surgical patients have an endotracheal tube inserted into their windpipe to help them breathe while under general anesthesia. These tubes have a "cuff" on the outside that is inflated in the trachea to help prevent fluids from leaking into the lungs. These cuffs come in different shapes and sizes. The TaperGuard endotracheal tube has a taper-shaped cuff that has been shown in animals to decrease the leakage of fluid past the cuff better than a traditional tube that has a barrel-shaped cuff. This study is designed to examine whether the use of the TaperGuard tube during surgery on humans decreases the amount of leakage past the cuff to a greater degree than the traditional barrel-shaped cuff. In addition, the study will investigate whether the use of the TaperGuard tube is associated with a decrease in respiratory complications often seen following surgery which may be related to fluid leaking past the cuff and into the lungs. It is thought that the use of the TaperGuard endotracheal tube will result in a decrease in fluid leakage past the cuff and that it will be associated with a decrease in respiratory complications during the 30 days after surgery.
Primary Outcome
Blue dye will be instilled above the endotracheal tube cuff immediately after intubation where it will remain for the duration of the surgery. The presence of dye leakage past the endotracheal tube cuff will be determined via analysis of bronchoscopic images taken at the end of the surgical procedure when surgical closure has begun.
Interventions
- DRUG Methylene Blue
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2012-04 |
| Est. Completion | 2013-05 |
| Phase | NA |
What the finished NCT01539135 record still lists
NCT01539135 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 1 intervention - of which Methylene Blue is the first listed.
NCT01539135 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01539135 about?
NCT01539135 is a clinical study titled "The Influence of Endotracheal Tube Design on Fluid Leakage Into the Lungs During Surgery". Surgical patients have an endotracheal tube inserted into their windpipe to help them breathe while under general anesthesia. These tubes have a "cuff" on the outside that is inflated in the trachea to help prevent fluids from leaking into the lungs. These cuffs come in different shapes and sizes. T...
What is the current status of trial NCT01539135?
This trial is currently completed. It is a NA study. The enrollment target is 80 participants. The study started on 2012-04. Estimated completion is 2013-05.
What interventions are being tested in trial NCT01539135?
The interventions under investigation include: Methylene Blue (DRUG).
Who is sponsoring clinical trial NCT01539135?
This trial is sponsored by Medtronic - MITG, which has 119 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01539135's enrollment target sits among peer trials
80 994th of 2000 higher than 941 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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