Clinical trial NCT01386879: Evaluation of Above the Cuff Suctioning During General Anesthesia
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Secretion Removal Above ETT Cuff
Keywords: suction
aspiration
general anesthesia
intubation
endotracheal tube
respiratory complications
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
Collaborators: name: Teleflex
First posted: 2011-07-01
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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)

Primary outcomes:
measure: Prevention of the Movement of Test Dye (Methylene Blue) From the Pharynx Into Patients' Trachea During Surgery
timeFrame: 4 hours
Secondary outcomes:
measure: Evaluation of pH of Secretions Collected Above Endotracheal Tube Cuff During Surgery
timeFrame: 4 hours
measure: the Ease of Tracheal Intubation Following the Induction of General Anesthesia Among the 3 Types of ETT
timeFrame: 1 hour
measure: Evaluation the Trachea and Vocal Cords at the Time of ETT Extubation to Determine Whether There is a Difference in the Amount of Mucosal Injury Between the 3 Types of ETT.
timeFrame: 4 hours
measure: Evaluation of Volume of Secretions Collected Above Endotracheal Tube Cuff During Surgery
timeFrame: 4 hours
measure: Evaluation of Bacterial Load of Secretions Collected Above Endotracheal Tube Cuff During Surgery
timeFrame: 4 hours
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Thomas Jefferson University Hospital
state: Pennsylvania
Study officials:
affiliation: Thomas Jefferson University
name: Boris Mraovic, MD
role: PRINCIPAL_INVESTIGATOR
References: