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

Trial Summary

What is the purpose of this trial?

The main objective of the proposed study is to clarify whether rotating a stylet-loaded endotracheal tube (ETT) 180 degrees prior to intubation will decrease the incidence of postoperative throat soreness, when compared to standard technique used in Standard of Care.

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 data supports the effectiveness of the treatment ETT 180, Stylet-loaded Endotracheal Tube, ETT 180?

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%, compared to lower success rates with other methods. This suggests that the ETT 180 technique may enhance the ease and effectiveness of intubation. ^{1 2 3 4 5}

Is the rotating breathing tube for endotracheal anesthesia safe for humans?

The safety of endotracheal tubes (ETTs) for prolonged use in mechanical ventilation is debated, and there are reports of potential issues like circuit leaks due to tube defects. However, specific safety data for the rotating breathing tube or similar designs like ETT 180 is not directly available from the provided research. ^{1 2 6 7 8}

How is the ETT 180 treatment different from other endotracheal intubation methods?

The ETT 180 treatment is unique because it involves rotating the endotracheal tube 180 degrees on the stylet, which improves the alignment and success rate of intubation compared to traditional methods. ^{2 3 5 9 10}

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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]

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 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 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]

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 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]

References

1. England pubmed.ncbi.nlm.nih.gov

Does the tube-compensation function of two modern mechanical ventilators provide effective work of breathing relief? [2018]

2. Korea (South) 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. [2023]

3. Japan pubmed.ncbi.nlm.nih.gov

[A better method to attach an endotracheal tube to the stylet of the Bullard laryngoscope]. [2006]

4. United States pubmed.ncbi.nlm.nih.gov

A new device to remove obstruction from endotracheal tubes during mechanical ventilation in critically ill patients. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Airway length in adults: estimation of the optimal endotracheal tube length for orotracheal intubation. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Safety of the endotracheal tube for prolonged mechanical ventilation. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Implementation of the TaperGuard™ endotracheal tube in an unselected surgical population to reduce postoperative pneumonia. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Full-thickness endotracheal tube defect resulting in an anaesthetic circuit leak. [2022]

9. India pubmed.ncbi.nlm.nih.gov

Endotrol tracheal tube and McGrath Mac are an effective combination for oral tracheal intubation. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Evaluation of respiratory system resistance in mechanically ventilated patients: the role of the endotracheal tube. [2019]