Evaluation of Above the Cuff Suctioning During General Anesthesia

What Was Tested

In this phase 4 trial, researchers set out to test Methylene blue (non-peptide stack partner).

It had three arms (groups): TaperGuard Evac ETT (experimental), one (experimental) and Standard ETT (active comparator).

Trachea will be intubated with Mallinckrodt™TaperGuard™ Evac Endotracheal Tube with a suction port to facilitate removal of secretions from the region of the trachea below the vocal cords and above the inflated ETT cuff.

Control group of patients will be intubated with a standard ETT without a suction port above the cuff (The Mallinckrodt Intermediate Hi-Lo Endotracheal Tube).

The registry classes the interventions as drug.

Who Took Part

50 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: Scheduled for elective abdominal surgery with an anticipated duration longer than 2 hours. ASA (American Society of Anesthesiologists) Physical status Classification 1 to 3. (1 - normal healthy patient, 2 - patients with mild systemic disease, 3 - patients with severe systemic disease). Endotracheal intubation anticipated to be routine (not difficult) based upon preoperative airway assessment.

The full record lists 3 inclusion and 9 exclusion criteria; among the exclusions: short duration surgery (anticipated \< 2 hours) or emergency (non-elective) surgery; anticipated difficult airway requiring technique other than direct laryngoscopy for intubation of the trachea; history of allergic reaction to methylene blue medication.

How the Study Was Run

It was run as a randomized, parallel-group and single-blind study.

The participants were allocated by chance, so the Methylene blue (non-peptide stack partner) group and the comparison group should start out alike.

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

In this single-blind Methylene blue (non-peptide stack partner) study one party knew the assignments and the other did not.

Those kept unaware of assignments: participant.

It started in 2011-07 with completion listed for 2012-10.

It ran at 1 site in United States.

Its stated primary purpose is prevention.

What Was Measured

It also tracked 5 secondary outcomes, for example Evaluation of pH of Secretions Collected Above Endotracheal Tube Cuff During Surgery, the Ease of Tracheal Intubation Following the Induction of General Anesthesia Among the 3 Types of ETT, Evaluation of Volume of Secretions Collected Above Endotracheal Tube Cuff During Surgery and Evaluation of Bacterial Load of Secretions Collected Above Endotracheal Tube Cuff During Surgery.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Methylene blue (non-peptide stack partner) in 50 people.

It ended early (terminated); 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.