The Influence of Endotracheal Tube Design on Fluid Leakage Into the Lungs During Surgery

What Was Tested

The trial (not phased) is built around Methylene blue (non-peptide stack partner).

Surgical patients have an endotracheal tube inserted into their windpipe to help them breathe while under general anesthesia.

These cuffs come in different shapes and sizes.

It had two arms (groups): Hi-Lo endotracheal tube (active comparator) and TaperGuard endotracheal tube (experimental).

The registry classes the interventions as drug.

More on the Plan

This study is designed to yield data on the intraoperative use of TaperGuard™endotracheal tubes and its potential influence on postoperative pulmonary complications and outcomes.

The intraoperative use of this tube (i.e. during short term intubation), and its impact on postoperative complications and outcomes has not been investigated.

Who Took Part

The registry lists 80 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Male or Female of all races. Older than 18 years old. Scheduled for an elective surgical procedure under general anesthesia for no less than 2hr and no more than 12hr with planned endotracheal intubation via the oral route. Willing and able to give informed consent for participation in the study. Expected hospital stay of greater than or equal to 23hrs.

The full record lists 6 inclusion and 16 exclusion criteria; among the exclusions: preexisting acute respiratory illness requiring antibiotic treatment within the two weeks prior to surgery; temperature of over 101 degrees f (38.3 c) at time of scheduled surgery; surgical requirement for naso-tracheal intubation.

How the Study Was Run

The set-up was randomized, parallel-group and triple-blind.

Random assignment meant chance, not the researchers, decided who got Methylene blue (non-peptide stack partner) and who got the comparison, which limits bias.

Groups ran in parallel: each of the participants stayed in one arm throughout.

As a double-blind Methylene blue (non-peptide stack partner) study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant, care provider and outcomes assessor.

It started in 2012-04 with completion listed for 2013-05.

It ran at 1 site in United States.

Its stated primary purpose is prevention.

What Was Measured

Researchers chose this as the main measure: Number of Participants With Dye Leakage (time frame: Duration of surgical procedure - from 2 to 12 hours).

It also tracked 3 secondary outcomes, for example Length of Hospital Stay, Number of Participants With Postoperative Pneumonia and Number of Participants With Unanticipated Intensive Care Unit Admission.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Methylene blue (non-peptide stack partner) in 80 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Methylene blue (non-peptide stack partner) compound page, all human trials.