Ignite Creation Date:
2025-12-25 @ 3:20 AM
Ignite Modification Date:
2025-12-26 @ 1:58 AM
Study NCT ID:
NCT07017205
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-15
First Post:
2025-06-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Microaspiration and Endotracheal Tubes
Sponsor:
Argentinian Intensive Care Society
Organization:
Study Overview
Official Title:
Automated Versus Manual Cuff Pressure Control for Preventing Microaspiration With TaperGuard Endotracheal Tubes in Elective Surgery: A Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial is to learn if a new method for managing breathing tube pressure is better at preventing fluid from leaking into patients' lungs during surgery. It will also check if it causes fewer side effects like a sore throat.
The main questions it aims to answer are:
Does using a continuous pressure controller reduce fluid leakage past the breathing tube cuff compared to the standard manual method? Does the continuous pressure controller lead to fewer and less severe sore throats and voice changes after surgery?
Researchers will compare two groups:
Group 1: Patients whose breathing tube cuff pressure is managed with a continuous automatic controller.
Group 2: Patients whose breathing tube cuff pressure is managed with the standard manual method.
Participants will:
Be randomly assigned to one of the two groups before their surgery. Receive a small, safe amount of blue dye in their mouth during the procedure to help measure leakage.
Have two small secretion samples collected from their breathing tube during surgery.
Be asked about sore throat and voice changes at 1, 2, 3, and 24 hours after the breathing tube is removed.
The main questions it aims to answer are:
Does using a continuous pressure controller reduce fluid leakage past the breathing tube cuff compared to the standard manual method? Does the continuous pressure controller lead to fewer and less severe sore throats and voice changes after surgery?
Researchers will compare two groups:
Group 1: Patients whose breathing tube cuff pressure is managed with a continuous automatic controller.
Group 2: Patients whose breathing tube cuff pressure is managed with the standard manual method.
Participants will:
Be randomly assigned to one of the two groups before their surgery. Receive a small, safe amount of blue dye in their mouth during the procedure to help measure leakage.
Have two small secretion samples collected from their breathing tube during surgery.
Be asked about sore throat and voice changes at 1, 2, 3, and 24 hours after the breathing tube is removed.
Detailed Description:
1. The Clinical Challenge: Microaspiration and the Breathing Tube
Endotracheal intubation is a life-saving procedure, but it inherently bypasses the body's natural defenses against lung infection. A critical, yet often overlooked, problem is microaspiration. This is the silent leakage of small amounts of oropharyngeal secretions past the cuff of the breathing tube and into the lower airways and lungs. This phenomenon is a primary contributor to the development of Ventilator-Associated Pneumonia (VAP), a serious complication that increases patient morbidity, mortality, and healthcare costs.
The cuff's primary role is to create a seal within the trachea. However, conventional cylindrical cuffs can form folds or channels when inflated, creating a direct pathway for secretions to leak through. Furthermore, maintaining the correct cuff pressure (recommended 25-30 cmH₂O) is challenging; pressure can fluctuate due to patient movement, changes in anesthesia gas volume, and surgical positioning.
2. Technological Innovations and the Evidence Gap
To address these issues, manufacturers have developed advanced endotracheal tubes. This study focuses on the TaperGuard™ Evac tube (Covidien/Medtronic), which features a uniquely shaped tapered cuff. This design is intended to inflate more uniformly against the tracheal wall, theoretically reducing the formation of leakage channels compared to traditional cylindrical cuffs.
Concurrently, technology for pressure management has evolved. While the current standard of care involves intermittent manual checks with a manometer, automated cuff pressure controllers (like the Pressure Easy® device) have been introduced. These devices continuously monitor and adjust the pressure, maintaining it within a pre-set target range throughout the entire procedure without manual intervention.
While laboratory (bench-top) studies strongly suggest that tapered cuffs are superior at preventing fluid leakage, and some early clinical studies are promising, there is a lack of robust, in-vivo evidence from a controlled surgical setting. This study aims to fill that gap by directly testing the combined effect of the advanced tube design with two different levels of pressure management sophistication.
3. The Study's Core Investigation: A Two-Factor Comparison
This trial is not just testing a new device, but rather investigating a clinical management strategy. The central question is: Does moving from a manual, intermittent pressure management protocol to a continuous, automated one provide a significant clinical benefit when using a modern, tapered-cuff endotracheal tube?
To answer this, we are employing a rigorous model to objectively quantify microaspiration:
The Blue Dye Model: A small, safe volume of blue dye is instilled into the patient's oropharynx above the cuff after intubation. The presence or absence of this dye in tracheal aspirate samples, collected later from below the cuff, serves as an objective, binary measure (Yes/No) of whether leakage has occurred.
4. Broader Impact and Secondary Patient-Centered Outcomes
Beyond the primary goal of preventing pneumonia, the study also investigates patient comfort and safety post-operatively. Damage to the tracheal mucosa from improper cuff pressure or physical irritation from the tube can lead to:
Post-extubation sore throat: A common and uncomfortable complaint.
Post-extubation dysphonia: Hoarseness or voice changes resulting from vocal cord irritation.
By ensuring more stable and optimal cuff pressure, the continuous controller may mitigate these issues. We will track these outcomes using standardized, validated scales (a Numeric Rating Scale for pain and the GRBAS scale for voice quality) to determine if the intervention leads to a tangible improvement in the patient's immediate recovery experience.
5. Methodological Rigor
To ensure the results are reliable and unbiased, the study employs key methodological safeguards:
Randomization: Patients are randomly assigned to a study group using a computer-generated sequence to ensure groups are comparable.
Partial Blinding: While the clinical team at the bedside cannot be blinded to the monitoring device, the laboratory analysis of the tracheal secretion samples is performed by personnel who are completely unaware of which group the sample came from. This prevents bias in determining the primary outcome.
In summary, this study seeks to provide high-quality evidence to guide clinical practice in operating rooms, determining if an investment in automated pressure control technology yields measurable benefits in patient safety and comfort when using state-of-the-art endotracheal tubes.
Endotracheal intubation is a life-saving procedure, but it inherently bypasses the body's natural defenses against lung infection. A critical, yet often overlooked, problem is microaspiration. This is the silent leakage of small amounts of oropharyngeal secretions past the cuff of the breathing tube and into the lower airways and lungs. This phenomenon is a primary contributor to the development of Ventilator-Associated Pneumonia (VAP), a serious complication that increases patient morbidity, mortality, and healthcare costs.
The cuff's primary role is to create a seal within the trachea. However, conventional cylindrical cuffs can form folds or channels when inflated, creating a direct pathway for secretions to leak through. Furthermore, maintaining the correct cuff pressure (recommended 25-30 cmH₂O) is challenging; pressure can fluctuate due to patient movement, changes in anesthesia gas volume, and surgical positioning.
2. Technological Innovations and the Evidence Gap
To address these issues, manufacturers have developed advanced endotracheal tubes. This study focuses on the TaperGuard™ Evac tube (Covidien/Medtronic), which features a uniquely shaped tapered cuff. This design is intended to inflate more uniformly against the tracheal wall, theoretically reducing the formation of leakage channels compared to traditional cylindrical cuffs.
Concurrently, technology for pressure management has evolved. While the current standard of care involves intermittent manual checks with a manometer, automated cuff pressure controllers (like the Pressure Easy® device) have been introduced. These devices continuously monitor and adjust the pressure, maintaining it within a pre-set target range throughout the entire procedure without manual intervention.
While laboratory (bench-top) studies strongly suggest that tapered cuffs are superior at preventing fluid leakage, and some early clinical studies are promising, there is a lack of robust, in-vivo evidence from a controlled surgical setting. This study aims to fill that gap by directly testing the combined effect of the advanced tube design with two different levels of pressure management sophistication.
3. The Study's Core Investigation: A Two-Factor Comparison
This trial is not just testing a new device, but rather investigating a clinical management strategy. The central question is: Does moving from a manual, intermittent pressure management protocol to a continuous, automated one provide a significant clinical benefit when using a modern, tapered-cuff endotracheal tube?
To answer this, we are employing a rigorous model to objectively quantify microaspiration:
The Blue Dye Model: A small, safe volume of blue dye is instilled into the patient's oropharynx above the cuff after intubation. The presence or absence of this dye in tracheal aspirate samples, collected later from below the cuff, serves as an objective, binary measure (Yes/No) of whether leakage has occurred.
4. Broader Impact and Secondary Patient-Centered Outcomes
Beyond the primary goal of preventing pneumonia, the study also investigates patient comfort and safety post-operatively. Damage to the tracheal mucosa from improper cuff pressure or physical irritation from the tube can lead to:
Post-extubation sore throat: A common and uncomfortable complaint.
Post-extubation dysphonia: Hoarseness or voice changes resulting from vocal cord irritation.
By ensuring more stable and optimal cuff pressure, the continuous controller may mitigate these issues. We will track these outcomes using standardized, validated scales (a Numeric Rating Scale for pain and the GRBAS scale for voice quality) to determine if the intervention leads to a tangible improvement in the patient's immediate recovery experience.
5. Methodological Rigor
To ensure the results are reliable and unbiased, the study employs key methodological safeguards:
Randomization: Patients are randomly assigned to a study group using a computer-generated sequence to ensure groups are comparable.
Partial Blinding: While the clinical team at the bedside cannot be blinded to the monitoring device, the laboratory analysis of the tracheal secretion samples is performed by personnel who are completely unaware of which group the sample came from. This prevents bias in determining the primary outcome.
In summary, this study seeks to provide high-quality evidence to guide clinical practice in operating rooms, determining if an investment in automated pressure control technology yields measurable benefits in patient safety and comfort when using state-of-the-art endotracheal tubes.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: