NCT01386879

Evaluation of Above the Cuff Suctioning During General Anesthesia

Evaluation of Microaspiration and Efficacy of Above the Cuff Suctioning During General Anesthesia: A Comparison of Two Endotracheal Tubes With Suction Above Cuff With a Standard Endotracheal Tube

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Thomas Jefferson University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Secretion Removal Above ETT Cuff

Interventions

Type	Name	Description
DRUG	methylene blue	A dilute solution of methylene blue (5 ml of 1 % methylene blue solution in saline, 1:1 dilution) will be gently delivered into the hypopharynx using a flexible suction catheter approximately once per hour until trachea is extubated.

Timeline

• Start date: 2011-07-01
• Primary completion: 2012-10-01
• Completion: 2012-10-01
• First posted: 2011-07-01
• Last updated: 2022-06-08
• Results posted: 2022-06-08

Locations

1 site across 1 country: United States