Rotating Breathing Tube for Endotracheal Anesthesia

Recruiting at 1 trial location

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Ohio State University

Disqualifiers: Pregnancy, Prisoners, Difficult airway, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 1 day

357 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if rotating a breathing tube 180 degrees before intubation reduces post-surgery sore throats compared to the usual method. Participants will be divided into groups using different techniques: standard laryngoscopy, video laryngoscopy with rotation, and standard laryngoscopy with rotation. The trial includes those undergoing surgery with a breathing tube (endotracheal tube, or ETT 180) who have no history of difficult airways or throat surgeries. Participants should not have a Body Mass Index (BMI) over 50. As an unphased trial, this study provides an opportunity to contribute to innovative research that could enhance surgical outcomes.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. Please consult with the trial coordinators or your doctor for guidance.

What prior data suggests that this rotating breathing tube technique is safe for endotracheal anesthesia?

Research shows that turning a special breathing tube 180 degrees before insertion is a new method, but direct safety data on it is not yet available. Existing studies do not specifically examine the safety of this 180-degree turn. However, since these breathing tubes and their guides are commonly used in medical procedures and are generally safe, this new turning technique does not immediately appear risky.

It is important to note that this study is not in a specific trial phase, indicating it may still be in the early testing stages. While specific safety data for this 180-degree turn is limited, the concept is based on established medical practices. Prospective participants should discuss any potential risks and benefits with the study team before deciding to join. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the rotating breathing tube trial because it explores innovative techniques to improve endotracheal anesthesia, a routine procedure in surgeries. Unlike traditional methods that use a standard laryngoscope for tube insertion, this trial investigates the potential benefits of rotating the tube 180 degrees during insertion. This maneuver, tested with both direct and video laryngoscopy, could make the process smoother and potentially reduce complications. By refining the method of tube placement, this trial aims to enhance patient safety and comfort during surgeries, making it a promising development in anesthetic management.

What evidence suggests that rotating the endotracheal tube 180 degrees is effective for reducing postoperative throat soreness?

This trial will compare different methods of inserting the endotracheal tube. Studies have shown that rotating the breathing tube 180 degrees significantly increases the likelihood of correct placement on the first attempt, achieving a 100% success rate. This technique may also reduce the risk of sore throat after surgery, a common issue for patients. The rotation helps prevent injuries from the stylet, a tool used during the procedure. Research suggests this method could make the process smoother and less irritating for the throat. Although more studies are needed, early results are promising for reducing discomfort after surgery. ^{1 2 5 6 7}

Are You a Good Fit for This Trial?

This trial is for individuals who are undergoing anesthesia through an endotracheal tube, a common procedure during surgery. There's no specific information on inclusion or exclusion criteria provided, so it's assumed that participants should be in good enough health to undergo the surgical procedure and anesthesia.

Inclusion Criteria

BMI < 50

My health is good to moderate, with some serious but not life-threatening conditions.

I am able to walk and will have general anesthesia with a breathing tube.

Exclusion Criteria

History of difficult airway

Critically ill patients requiring intensive care

Prisoners

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants undergo endotracheal intubation with different techniques to assess the incidence of postoperative sore throat

1 day

1 visit (in-person)

Follow-up

Participants are monitored for symptoms of hoarseness or sore throat in the Post Anesthesia Care Unit and 24 hours after endotracheal tube removal

24 hours

1 visit (in-person or phone-call)

What Are the Treatments Tested in This Trial?

Interventions

• ETT 180

Trial Overview

The study is testing if rotating the endotracheal tube (a breathing tube) 180 degrees before inserting it with the help of tools like Direct Laryngoscope or Video laryngoscope can reduce throat soreness after surgery compared to the standard method.

How Is the Trial Designed?

Group I: Direct Laryngoscopy (DL) Active Control 1 Intervention

Standard laryngoscope use to insert the endotracheal tube and removing the stylet without any rotation.

Group II: Video laryngoscopy plus Endotracheal Tube (ETT) 180 maneuver (VLE) Active Control 2 Interventions

Video laryngoscope use to insert the endotracheal tube and removing the stylet using a 180-degree rotation.

Group III: Direct laryngoscopy (DLE) plus Endotracheal Tube (ETT) 180 maneuver Active Control 2 Interventions

Standard laryngoscope use to insert the endotracheal tube and removing the stylet using a 180-degree rotation.

Who Is Running the Clinical Trial?

Ohio State University

Lead Sponsor

Trials

891

Recruited

2,659,000+

Published Research Related to This Trial

In a study of 108 patients, rotating the endotracheal tube (ETT) 180 degrees to direct the bevel to the right significantly improved first-attempt intubation success to 100%, compared to 56% in the control group and 83% in the manufacturer-recommended method.

The new method of angulating the ETT can be applied to any ETT, enhancing the likelihood of successful intubation in patients with airway difficulties, as all patients who initially failed were successfully intubated on the second attempt using this technique.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[A better method to attach an endotracheal tube to the stylet of the Bullard laryngoscope]. Katoh, H., Nishiyama, J., Takiguchi, M., et al.[2006]

In a study of 110 infants and neonates, using a C-curved stylet for endotracheal intubation significantly reduced tube handling time and total intubation duration compared to a hockey stick-shaped stylet.

The C-curved stylet also resulted in a higher success rate of intubation within 30 seconds and was rated as easier to use by laryngoscope operators, indicating its potential advantages in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Usefulness of C-curved stylet for intubation with the C-MAC® Miller videolaryngoscope in neonates and infants: a prospective randomized controlled trial. Park, JB., Kang, PY., Kim, T., et al.[2023]

Using the Endotrol® tracheal tube with the McGrath® video laryngoscope significantly reduced intubation time compared to using a rigid stylet with the same laryngoscope or a direct laryngoscope, with a median time of 32 seconds for the Endotrol group versus 37 seconds for the others.

Patients intubated with the Endotrol experienced no sore throats, while those in the other groups reported higher rates of sore throat, indicating that this combination not only improves efficiency but also enhances patient comfort post-procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endotrol tracheal tube and McGrath Mac are an effective combination for oral tracheal intubation. Shimazaki, A., Ueshima, H., Otake, H.[2022]

In a study of 128,977 adults receiving mechanical ventilation in ICUs, endotracheal tubes (ETT) were associated with higher mortality rates compared to tracheostomy tubes (TT) after 9 days of ventilation, indicating potential safety concerns for long-term use of ETT.

The analysis showed that while ETT is commonly used for short-term ventilation, its safety beyond 9 days remains uncertain, suggesting a need for further research to evaluate the risks associated with prolonged ETT use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of the endotracheal tube for prolonged mechanical ventilation. Duke, GJ., Moran, JL., Santamaria, JD., et al.[2022]

In a study involving 12 patients in a general ICU, measuring airway pressure 2 cm below the endotracheal tube (ETT) provided significantly lower resistance values compared to measurements taken at the distal end of the ETT, indicating that ETT positioning affects airflow resistance.

The findings suggest that for accurate evaluation of respiratory system mechanics during mechanical ventilation, measurements should be taken from the tracheal level to exclude the additional resistance caused by the ETT itself.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of respiratory system resistance in mechanically ventilated patients: the role of the endotracheal tube. Conti, G., De Blasi, RA., Lappa, A., et al.[2019]

In a study of 15,388 surgical patients, the TaperGuard™ endotracheal tube (ETT) did not significantly reduce the incidence of postoperative pneumonia compared to the standard ETT, with rates of 1.62% and 1.79% respectively.

The use of the TaperGuard™ ETT was associated with a higher hospital mortality rate (1.5%) compared to the standard ETT (1.0%), suggesting that simply modifying ETT design may not improve outcomes in surgical patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of the TaperGuard™ endotracheal tube in an unselected surgical population to reduce postoperative pneumonia. Martini, RP., Yanez, ND., Treggiari, MM., et al.[2021]

In a study comparing the Nellcor Puritan-Bennett 840 and Dräger Evita 4 ventilators using a model lung, neither ventilator could fully compensate for the work of breathing imposed by an endotracheal tube (ETT), even at 100% tube compensation (TC).

The research indicated that a small amount of pressure support ventilation was equally effective in reducing inspiratory effort compared to TC, suggesting that physicians should consider this when planning weaning trials for mechanically ventilated patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does the tube-compensation function of two modern mechanical ventilators provide effective work of breathing relief? Maeda, Y., Fujino, Y., Uchiyama, A., et al.[2018]

The experimental obstruction remover (OR) significantly reduced endotracheal tube (ETT) resistance in 8 critically ill patients, improving airflow and making ventilation more effective.

Using the OR also decreased the work of breathing required to overcome ETT resistance, demonstrating its potential to safely clear obstructions without interrupting mechanical ventilation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A new device to remove obstruction from endotracheal tubes during mechanical ventilation in critically ill patients. Conti, G., Rocco, M., De Blasi, RA., et al.[2019]

In a case involving an 18-year-old Standardbred gelding undergoing anesthesia for colic, a significant gas leak from the endotracheal tube (ETT) was detected, attributed to a full-thickness laceration likely caused by dental damage.

The incident highlights the critical need for thorough inspection of the ETT before use in equine anesthesia to ensure airway integrity and effective ventilation, especially in emergency situations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Full-thickness endotracheal tube defect resulting in an anaesthetic circuit leak. Miller, L., Lord, S.[2022]

In a study of 293 patients undergoing orotracheal intubation, researchers found that the optimal length for the endotracheal tube (ETT) tip should be positioned 5 cm above the carina, which is the point where the trachea splits into the bronchi.

A formula was developed to estimate the optimal ETT length based on a patient's height, providing a practical guide for clinicians to ensure proper tube placement during intubation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Airway length in adults: estimation of the optimal endotracheal tube length for orotracheal intubation. Cherng, CH., Wong, CS., Hsu, CH., et al.[2022]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10701272/

Postoperative sore throat: prophylaxis and treatment - PMC

A novel intubation technique with endotracheal tube (ETT) rotation 180 degrees (ETT 180°) has been suggested to overcome stylet related injury and, possibly ...

2.

withpower.com

withpower.com/trial/phase-anesthesia-endotracheal-4-2023-205fd

Rotating Breathing Tube for Endotracheal Anesthesia

A study showed that rotating the endotracheal tube (ETT) 180 degrees on the stylet improved the success rate of intubation on the first attempt to 100%, ...

3.

researchgate.net

researchgate.net/figure/ETT-180-intubation-technique_fig1_376407054

ETT 180° intubation technique.

Patients undergoing GA with tracheal intubation may experience a common complication, known as postoperative sore throat (POST). We conducted this study to ...

4.

ctv.veeva.com

ctv.veeva.com/study/ett-180-stylet-loaded-endotracheal-tube-rotation-before-insertion

Stylet-loaded Endotracheal Tube Rotation Before Insertion

The main objective of the proposed study is to clarify whether rotating a stylet-loaded endotracheal tube (ETT) 180 degrees prior to intubation ...

5.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8144872/

Effect of the use of an endotracheal tube and stylet versus an ...

The effect of the routine use of a stylet during tracheal intubation on first-attempt intubation success is unclear.

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8501608/

Is there an optimal place to hold the endotracheal tube ...

The findings of this study will provide scientific evidence for suggesting an appropriate place for holding the ETT during direct laryngoscopy procedures.

7.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S221084402400162X

Unveiling the significance of cuff pressure in anaesthesia

Inadequate pressure in the endotracheal tube (ETT) cuff can lead to compromised ventilation or airway injury. Accurate assessment of ETT cuff pressure is ...