Evaluation of Above the Cuff Suctioning During General Anesthesia

This study has been terminated.
(The study was terminated because of slower than anticipated enrollment)
Sponsor:
Collaborator:
Teleflex
Information provided by (Responsible Party):
Thomas Jefferson University
ClinicalTrials.gov Identifier:
NCT01386879
First received: June 27, 2011
Last updated: June 3, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
Secretion Removal Above ETT Cuff
Drug: methylene blue
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by Thomas Jefferson University:

Primary Outcome Measures:
  • Prevention of the movement of test dye (methylene blue) from the pharynx into patients' trachea during surgery [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    The primary objective of the pilot study is to evaluate whether there is a difference between the 3 types of ETT in preventing the movement of test dye (methylene blue) from the pharynx into the trachea, past the inflated cuff. After tracheal intubation a small amount of methylene blue will be instilled into patients' pharynx every 60 minutes. The presence or absence of blue dye above and below the ETT cuff will be evaluated every 20 minutes using a video recording fiberoptic bronchoscope.


Secondary Outcome Measures:
  • Evaluation of pH of secretions collected above endotracheal tube cuff during surgery [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    Secretions will be continuously suctioned from suction port of the two ETT with suction above the cuff port (TaperGard Evac ETT and Telefles ISIS ETT) into a Luken's trap. We will evaluate whether there is a difference in the volume, pH and bacterial load of the aspirate between two ETT with suction above the cuff port.

  • the ease of tracheal intubation following the induction of general anesthesia among the 3 types of ETT [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
  • 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. [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
  • Evaluation whether there is a difference in combined postoperative respiratory complications among the 3 types of ETT. [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
  • Evaluation of volume of secretions collected above endotracheal tube cuff during surgery [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    Secretions will be continuously suctioned from suction port of the two ETT with suction above the cuff port (TaperGard Evac ETT and Telefles ISIS ETT) into a Luken's trap. We will evaluate whether there is a difference in the volume, pH and bacterial load of the aspirate between two ETT with suction above the cuff port.

  • Evaluation of bacterial load of secretions collected above endotracheal tube cuff during surgery [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    Secretions will be continuously suctioned from suction port of the two ETT with suction above the cuff port (TaperGard Evac ETT and Telefles ISIS ETT) into a Luken's trap. We will evaluate whether there is a difference in the volume, pH and bacterial load of the aspirate between two ETT with suction above the cuff port.


Enrollment: 60
Study Start Date: July 2011
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TaperGuard Evac ETT
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
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.
Other Name: Urolene Blue
Experimental: Teleflex ISIS ETT
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
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.
Other Name: Urolene Blue
Active Comparator: Standard ETT
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)
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.
Other Name: Urolene Blue

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01386879

Locations
United States, Pennsylvania
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Thomas Jefferson University
Teleflex
Investigators
Principal Investigator: Boris Mraovic, MD Thomas Jefferson University
  More Information

No publications provided

Responsible Party: Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT01386879     History of Changes
Other Study ID Numbers: 11D.48
Study First Received: June 27, 2011
Last Updated: June 3, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Thomas Jefferson University:
suction
aspiration
general anesthesia
intubation
endotracheal tube
respiratory complications

Additional relevant MeSH terms:
Anesthetics
Methylene Blue
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 22, 2014