Evaluation of Above the Cuff Suctioning During General Anesthesia

Thomas Jefferson University

Status and phase: Terminated; Phase 4

Conditions: Secretion Removal Above ETT Cuff

Treatments: Drug: methylene blue

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01386879

11D.48

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 3 patient groups

TaperGuard Evac ETT

Experimental group

Description:

Trachea will be intubated with Mallinckrodt™TaperGuard™ Evac Endotracheal Tube with a suction port to facilitate removal of secretions from the region of the trachea below the vocal cords and above the inflated ETT cuff

Treatment:

Drug: methylene blue

Teleflex ISIS ETT

Experimental group

Description:

Trachea will be intubated with Teleflex ISIS HVT Cuffed Tracheal Tube with Subglottic Secretion suction port to facilitate removal of secretions from the region of the trachea below the vocal cords and above the inflated ETT cuff

Treatment:

Drug: methylene blue

Standard ETT

Active Comparator group

Description:

Control group of patients will be intubated with a standard ETT without a suction port above the cuff (The Mallinckrodt Intermediate Hi-Lo Endotracheal Tube)

Treatment:

Drug: methylene blue