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

Primary Purpose

Respiratory Aspiration

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Methylene Blue

About this trial

This is an interventional prevention trial for Respiratory Aspiration focused on measuring Aspiration, Respiratory

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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
Unwilling or unable to give informed consent for participation in the study

Sites / Locations

Tulane University Hospital and Clinics

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Hi-Lo endotracheal tube

TaperGuard endotracheal tube

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Length of Hospital Stay

Time of readiness for discharge from PACU, defined as when an Aldrete score of greater than or equal to 8 is given, to the time at which discharge (from the hospital) orders are written. The inpatient period may extend up to 72 hours.

Number of Participants With Postoperative Pneumonia

Diagnosis of postoperative pneumonia during the 30 day follow up period after surgery

Number of Participants With Unanticipated Intensive Care Unit Admission

Incidence of unscheduled Intensive Care Unit admission after surgery and length of ICU stay if applicable.

Full Information

NCT ID

NCT01539135

First Posted

February 6, 2012

Last Updated

August 5, 2015

Sponsor

Medtronic - MITG

1. Study Identification

Unique Protocol Identification Number

NCT01539135

Brief Title

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

Official Title

The Influence of Endotracheal Tube Cuff Design on Intraoperative Microaspiration and Postoperative Respiratory Complications

Study Type

Interventional

2. Study Status

Record Verification Date

August 2015

Overall Recruitment Status

Completed

Study Start Date

April 2012 (undefined)

Primary Completion Date

May 2013 (Actual)

Study Completion Date

May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Medtronic - MITG

4. Oversight

Data Monitoring Committee

5. Study Description

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.

Detailed Description

This study is designed to yield data on the intraoperative use of TaperGuard™endotracheal tubes and its potential influence on postoperative pulmonary complications and outcomes. The TaperGuard Basic tube has a taper-shaped cuff and has been shown, via bench and animal testing, to decrease microaspiration, which has been associated with respiratory difficulties. The intraoperative use of this tube (i.e. during short term intubation), and its impact on postoperative complications and outcomes has not been investigated. This study will determine whether the intraoperative use of the TaperGuard tube results in a decrease in microaspiration compared to the Hi-Lo endotracheal tube having a barrel-shaped cuff. Moreover, the relationship between a decrease in microaspiration and subsequent decrease in postoperative respiratory complications will be explored.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Respiratory Aspiration

Keywords

Aspiration, Respiratory

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderOutcomes Assessor

Allocation

Randomized

Enrollment

80 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Hi-Lo endotracheal tube

Arm Type

Active Comparator

Arm Description

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

Arm Title

TaperGuard endotracheal tube

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Methylene Blue

Other Intervention Name(s)

Methylene Blue Dye

Intervention Description

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

Primary Outcome Measure Information:

Title

Number of Participants With Dye Leakage

Description

Time Frame

Duration of surgical procedure - from 2 to 12 hours

Secondary Outcome Measure Information:

Title

Length of Hospital Stay

Description

Time Frame

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

Title

Number of Participants With Postoperative Pneumonia

Description

Diagnosis of postoperative pneumonia during the 30 day follow up period after surgery

Time Frame

Up to 30 days after surgery

Title

Number of Participants With Unanticipated Intensive Care Unit Admission

Description

Incidence of unscheduled Intensive Care Unit admission after surgery and length of ICU stay if applicable.

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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 Unwilling or unable to give informed consent for participation in the study

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sabrina Bent, MD

Organizational Affiliation

Tulane University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Tulane University Hospital and Clinics

City

New Orleans

State/Province

Louisiana

ZIP/Postal Code

70112

Country

United States

12. IPD Sharing Statement

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

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