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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 is a Phase 4 study that was terminated before completion, run by Thomas Jefferson University. The registered enrollment target is 50 participants.
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.
Interventions
- DRUG methylene blue
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2011-07 |
| Est. Completion | 2012-10 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01386879
The ClinicalTrials.gov registry entry for NCT01386879 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Thomas Jefferson University, which has 292 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which methylene blue is the first listed.
NCT01386879 reports 0 study locations.
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.
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