Trial · Interventional

CompletedNot applicableResults postedRegistry data

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

NCTNCT01539135Other idCOVAIPR0235

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Overview

Status: Completed
Phase: Not applicable
Enrollment: 80 participants (actual)
Sponsor: Medtronic - MITG · Industry
Design: Randomized · Triple masking
Countries: 1 country
United States
Start: Apr 2012
Primary completion: May 2013
Completion: May 2013
First posted: 27 Feb 2012 (estimated)
Last update posted: 13 Aug 2015 (estimated)
Conditions: Respiratory Aspiration

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

201220132014

N/A
The Influence of Endotracheal Tube Design on Fluid Leakage Into the Lungs During Surgery
NCT01539135
Apr 2012 to May 2013

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

Methylene BlueDrug

Arms2

Active comparator
Hi-Lo endotracheal tube
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
Experimental
TaperGuard endotracheal tube
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

Primary outcomes1

Outcomes the sponsor listed as primary.

Number of Participants With Dye Leakage
Time frame · Duration of surgical procedure - from 2 to 12 hours
Registry description
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 outcomes(3)

Length of Hospital Stay
Time frame · Time from discharge from PACU to discharge from hospital up to 72 hours
Registry description
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
Time frame · Up to 30 days after surgery
Registry description
Diagnosis of postoperative pneumonia during the 30 day follow up period after surgery
Number of Participants With Unanticipated Intensive Care Unit Admission
Time frame · Time from discharge from PACU to discharge from hospital up to 72 hours
Registry description
Incidence of unscheduled Intensive Care Unit admission after surgery and length of ICU stay if applicable.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeNumber· Duration of surgical procedure - from 2 to 12 hours

Number of Participants With Dye Leakage

Group	Value (participants)
Hi-Lo Endotracheal Tube	3
TaperGuard Endotracheal Tube	2

Secondary and other outcome results(3)

Secondary outcomeMean· Time from discharge from PACU to discharge from hospital up to 72 hours

Length of Hospital Stay

Group	Value (hours)	Spread
Hi-Lo Endotracheal Tube	42.4	19.6
TaperGuard Endotracheal Tube	34.9	16.7

Secondary outcomeNumber· Up to 30 days after surgery

Number of Participants With Postoperative Pneumonia

Group	Value (participants)
Hi-Lo Endotracheal Tube	1
TaperGuard Endotracheal Tube	0

Secondary outcomeNumber· Time from discharge from PACU to discharge from hospital up to 72 hours

Number of Participants With Unanticipated Intensive Care Unit Admission

Group	Value (participants)
Hi-Lo Endotracheal Tube	3
TaperGuard Endotracheal Tube	3

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
Hi-Lo Endotracheal TubeHi-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 Methylene Blue: 20 cc methylene blue instilled above the cuff once after intubation for the duration of the surgical procedure	–	0 / 43	0 / 43
TaperGuard Endotracheal TubeTaperGuard 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 Methylene Blue: 20 cc methylene blue instilled above the cuff once after intubation for the duration of the surgical procedure	–	0 / 37	0 / 37

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

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

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