TerminatedPhase 4

Evaluation of Above the Cuff Suctioning During General Anesthesia

Stopped: The study was terminated because of slower than anticipated enrollment

United States50 participantsStarted 2011-07

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Exclusion Criteria: * Short duration surgery (anticipated \< 2 hours) or emergency (non-elective) surgery * ASA Physical status Classification 4 to 5. (4 - patients with severe systemic diseases that is a constant threat to life, 5 - Moribund patients who are not expected to survive without the operation) * Anticipated difficult airway requiring technique other than direct laryngoscopy for intubation of the trachea. * Pregnancy * History of allergic reaction to Methylene Blue medication * Methemoglobinemia, glucose-6-phosphate dehydrogenase (G6PD) deficiency * History of symptomatic chronic obstructive pulmonary disease (asthma, bronchitis, emphysema) or recent pneumonia (\< 6 months prior to surgery). * Hypoxemia (hemoglobin oxygen saturation \< 90% room air or on O2 at home or in hospital) * History of coagulopathy, IV heparin therapy, or coumadin therapy (INR \> 2.5)

What they're measuring

Prevention of the Movement of Test Dye (Methylene Blue) From the Pharynx Into Patients' Trachea During Surgery

Timeframe: 4 hours

Trial details

NCT IDNCT01386879

SponsorThomas Jefferson University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2012-10

Results submitted2021-11-16