The Influence of Endotracheal Tube Design on Fluid Leakage Into the Lungs During Surgery

NCT01539135 | Completed Results

• 1 other identifier: COVAIPR0235
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Surgical patients have an endotracheal tube inserted into their windpipe to help them breathe while under general anesthesia. These tubes have a "cuff" on the outside that is inflated in the trachea to help prevent fluids from leaking into the lungs. These cuffs come in different shapes and sizes. The TaperGuard endotracheal tube has a taper-shaped cuff that has been shown in animals to decrease the leakage of fluid past the cuff better than a traditional tube that has a barrel-shaped cuff. This study is designed to examine whether the use of the TaperGuard tube during surgery on humans decreases the amount of leakage past the cuff to a greater degree than the traditional barrel-shaped cuff. In addition, the study will investigate whether the use of the TaperGuard tube is associated with a decrease in respiratory complications often seen following surgery which may be related to fluid leaking past the cuff and into the lungs. It is thought that the use of the TaperGuard endotracheal tube will result in a decrease in fluid leakage past the cuff and that it will be associated with a decrease in respiratory complications during the 30 days after surgery.

Conditions

Respiratory Aspiration

Keywords

Aspiration, Respiratory

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Dye Leakage

  Blue dye will be instilled above the endotracheal tube cuff immediately after intubation where it will remain for the duration of the surgery. The presence of dye leakage past the endotracheal tube cuff will be determined via analysis of bronchoscopic images taken at the end of the surgical procedure when surgical closure has begun.

  Duration of surgical procedure - from 2 to 12 hours

Secondary Outcomes (3)

• Length of Hospital Stay

  Time from discharge from PACU to discharge from hospital up to 72 hours

• Number of Participants With Postoperative Pneumonia

  Up to 30 days after surgery

• Number of Participants With Unanticipated Intensive Care Unit Admission

  Time from discharge from PACU to discharge from hospital up to 72 hours

Study Arms (2)

Hi-Lo endotracheal tube

ACTIVE COMPARATOR

Hi-Lo endotracheal tube with barrel shaped cuff with 20 cc of methylene blue instilled above the cuff once post intubation for the duration of the surgical procedure

Drug: Methylene Blue

TaperGuard endotracheal tube

EXPERIMENTAL

TaperGuard endotracheal tube with taper shaped cuff with 20 cc methylene blue instilled above the cuff once post intubation for the duration of the surgical procedure

Drug: Methylene Blue

Interventions

Methylene Blue DRUG

20 cc methylene blue instilled above the cuff once after intubation for the duration of the surgical procedure

Also known as: Methylene Blue Dye

Hi-Lo endotracheal tube; TaperGuard endotracheal tube

Eligibility Criteria

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

You may qualify if:

• Male or Female of all races
• Older than 18 years old
• Scheduled for an elective surgical procedure under general anesthesia for no less than 2hr and no more than 12hr with planned endotracheal intubation via the oral route
• Willing and able to give informed consent for participation in the study
• Anticipated extubation at the conclusion of general anesthesia in the operating room and prior to admission to the PACU
• Expected hospital stay of greater than or equal to 23hrs

You may not qualify if:

• Preexisting acute respiratory illness requiring antibiotic treatment within the two weeks prior to surgery
• Temperature of over 101 degrees F (38.3 C) at time of scheduled surgery
• Surgical requirement for naso-tracheal intubation
• Patients undergoing surgical procedures directly on the lungs, trachea, or airways
• Presence of tracheostomy
• History of allergic reaction to methylene blue
• Methemoglobinemia, glucose-6-phosphate (G6PD) deficiency
• Renal insufficiency or failure
• Requirement for prolonged intubation and/or ventilation beyond the point of PACU admission
• Intraoperative use of nitrous oxide, to avoid the increase in cuff pressure due to diffusion of gas over time
• Psychiatric drugs of the following classifications: selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), and monoamine oxidase inhibitors (MAOIs).
• Patients younger than 18 years of age
• Prone positioning during surgery
• Pregnant or lactating women based on standardized preoperative screening protocols
• Legally detained prisoner status

Sponsors & Collaborators

• Medtronic - MITG: lead

Study Sites (1)

Tulane University Hospital and Clinics

New Orleans, Louisiana, 70112, United States

Location

MeSH Terms

Conditions

Respiratory Aspiration

Interventions

Methylene Blue

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Limitations and Caveats

This was a feasibility study and based on the results, we do not believe that a larger, multicenter randomized controlled trial would be appropriate. The study wasn't powered to find any significant differences.

Results Point of Contact

• Title: Dr. Sabrina Bent
• Organization: Tulane University Hospital and Clinics

sabrina.bent@hcahealthcare.com

5049887137

Study Officials

• Sabrina Bent, MD

  Tulane University

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2012
• First Posted: February 27, 2012
• Study Start: April 1, 2012
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: August 13, 2015
• Results First Posted: August 13, 2015

Record last verified: 2015-08

Locations

US (1)