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NCT01386879 · ClinicalTrials.gov registry record · Phase 4
Evaluation of Above the Cuff Suctioning During General Anesthesia
A Phase 4 study, sponsored by Thomas Jefferson University.
- Terminated
- Registry status
- Phase 4
- Development phase
- 50
- Enrollment target
NCT01386879: Clinical Trial Phase 4 study, sponsored by Thomas Jefferson University.
NCT01386879 is a Phase 4 study that was terminated before completion, run by Thomas Jefferson University. The registered enrollment target is 50 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01386879, a Phase 4 study, was terminated before completion, sponsored by Thomas Jefferson University.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 50 participants
- Enrollment target
Study Summary
The aim of this prospective, randomized, pilot study is compare ease of tracheal intubation, amount of microaspiration and efficacy of secretion removal using three FDA (Food and Drug Administration)-cleared endotracheal tubes (ETT) after the induction of general anesthesia in the operating room (OR). Studies in the intensive care unit (ICU) have demonstrated a significant reduction in the incidence of ventilator acquired pneumonia when a ETT with suction above the cuff is used to remove secretions that accumulate above the inflated cuff. This will be the first study to evaluate the efficacy of above the cuff suctioning during general anesthesia and surgery. One hundred and ten adult patients undergoing elective abdominal surgery (general, colorectal or gynecological) requiring general anesthesia with an endotracheal tube and mechanical ventilation will be randomized into 3 groups to receive one of the following three endotracheal tubes: 1. Teleflex ISIS HVT Cuffed Tracheal Tube with Subglottic Secretion Suction Port Endotracheal Tube (Teleflex ISIS ETT). 2. Mallinckrodt TaperGuard Evac Endotracheal Tube (TaperGuard Evac ETT). 3. Mallinckrodt Intermediate Hi-Lo Endotracheal Tube. (Standard ETT) The first two groups will be compared to standard ETT (third group) regarding easy of tracheal intubation, efficacy of suctioning of secretions, efficacy of sealing the trachea with an inflated ETT cuff by preventing the movement of test dye (methylene blue) from the pharynx into the trachea and incidence of post-operative respiratory complications.
Primary Outcome
The primary objective of the pilot study is to evaluate whether there is a difference between the 3 types of ETT in preventing the movement of test dye (methylene blue) from the pharynx into the trachea, past the inflated cuff. After tracheal intubation a small amount of methylene blue will be instilled into patients' pharynx every 60 minutes. The presence or absence of blue dye above and below the ETT cuff will be evaluated every 20 minutes using a video recording fiberoptic bronchoscope.
Interventions
- DRUG methylene blue
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2011-07 |
| Est. Completion | 2012-10 |
| Phase | Phase 4 |
Why NCT01386879 stopped before completion
NCT01386879 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 1 intervention - of which methylene blue is the first listed.
NCT01386879 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01386879 about?
NCT01386879 is a clinical study titled "Evaluation of Above the Cuff Suctioning During General Anesthesia". The aim of this prospective, randomized, pilot study is compare ease of tracheal intubation, amount of microaspiration and efficacy of secretion removal using three FDA (Food and Drug Administration)-cleared endotracheal tubes (ETT) after the induction of general anesthesia in the operating room (OR...
What is the current status of trial NCT01386879?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 50 participants. The study started on 2011-07. Estimated completion is 2012-10.
What interventions are being tested in trial NCT01386879?
The interventions under investigation include: methylene blue (DRUG).
Who is sponsoring clinical trial NCT01386879?
This trial is sponsored by Thomas Jefferson University, which has 292 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01386879's enrollment target sits among peer trials
50 1255th of 2000 higher than 678 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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