Evaluation of Above the Cuff Suctioning During General Anesthesia

NCT01386879 | Terminated Phase 4 Results

• 1 other identifier: 11D.48
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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. 1.Teleflex ISIS HVT Cuffed Tracheal Tube with Subglottic Secretion Suction Port Endotracheal Tube (Teleflex ISIS ETT).
2. 2.Mallinckrodt TaperGuard Evac Endotracheal Tube (TaperGuard Evac ETT).
3. 3.Mallinckrodt Intermediate Hi-Lo Endotracheal Tube. (Standard ETT)

Conditions

Secretion Removal Above ETT Cuff

Keywords

suction; aspiration; general anesthesia; intubation; endotracheal tube; respiratory complications

Outcome Measures

Primary Outcomes (1)

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

  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.

  4 hours

Secondary Outcomes (5)

• Evaluation of pH of Secretions Collected Above Endotracheal Tube Cuff During Surgery

  4 hours

• the Ease of Tracheal Intubation Following the Induction of General Anesthesia Among the 3 Types of ETT

  1 hour

• 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.

  4 hours

• Evaluation of Volume of Secretions Collected Above Endotracheal Tube Cuff During Surgery

  4 hours

• Evaluation of Bacterial Load of Secretions Collected Above Endotracheal Tube Cuff During Surgery

  4 hours

Study Arms (3)

TaperGuard Evac ETT

EXPERIMENTAL

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

Teleflex ISIS ETT

EXPERIMENTAL

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

Standard ETT

ACTIVE COMPARATOR

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

Interventions

methylene blue DRUG

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.

Also known as: Urolene Blue

Standard ETT; TaperGuard Evac ETT; Teleflex ISIS ETT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Thomas Jefferson University: lead
• Teleflex: collaborator

Study Sites (1)

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Interventions

Methylene Blue

Intervention Hierarchy (Ancestors)

Phenothiazines; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Boris Mraovic
• Organization: University of Missouri Columbia

mraovicb@health.missouri.edu

573-882-2568

Study Officials

• Boris Mraovic, MD

  Thomas Jefferson University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2011
• First Posted: July 1, 2011
• Study Start: July 1, 2011
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: June 8, 2022
• Results First Posted: June 8, 2022

Record last verified: 2022-05

Locations

US (1)