Evaluation of Above the Cuff Suctioning During General Anesthesia
Condition: Secretion Removal Above ETT Cuff
Intervention: methylene blue
Intervention description: 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.
Intervention MeSH terms: Methylene Blue
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 50.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: suction; aspiration; general anesthesia; intubation; endotracheal tube; respiratory complications

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.
    

Eligibility criteria:

        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)