Endoscopic Airway Examination for Predicting Intubation Complications

Overseen By Shanna Graves

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Alabama at Birmingham

Disqualifiers: Under 18, Unwilling or unable examination

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

Approved in 6 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a new endoscopic examination, using a small camera, can better predict intubation complications than the traditional Mallampati test. Researchers believe the new method might provide clearer insights into potential difficulties during the procedure. The study involves a simple airway assessment using a camera and targets individuals classified as ASA status 1-4, indicating they are generally healthy or have mild to severe systemic disease. Participants should be willing and able to undergo this comprehensive airway examination. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance future airway management techniques.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this endoscopic examination is safe for predicting intubation complications?

Research has shown that procedures like the one in this study, called endoscopic exams, are generally safe. A large study found that serious problems occur in only 0.5 to 3 out of every 10,000 procedures. Most issues relate to heart and lung problems during the exam, but they are rare. Thus, most people handle endoscopic exams well. Based on this information, participants in the study can feel confident about the procedure's safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the endoscopic airway examination because it offers a more detailed assessment of the airway, potentially predicting intubation complications better than the traditional Mallampati score alone. This technique provides a direct visual evaluation, which can help identify anatomical variations that might lead to complications during intubation. By improving the accuracy of airway assessments, this method could enhance patient safety and reduce the risk of unexpected issues during medical procedures.

What evidence suggests that this endoscopic examination is effective for predicting intubation complications?

Research has shown that using a camera to examine the throat, as performed in the endoscopic examination in this trial, can help predict problems during breathing tube placement. This method allows doctors to view the airway directly, aiding in the identification of potential issues. Early results suggest that this camera approach might be more accurate than traditional methods like the Mallampati test, which assesses airway accessibility. With clearer visibility, doctors can better anticipate and prepare for challenges during the procedure, potentially leading to fewer unexpected issues and smoother experiences with breathing tube placement. ^{1 2 6 7 8}

Who Is on the Research Team?

Michael Froelich, MD, MS

Principal Investigator

University of Alabama at Birmingham

Are You a Good Fit for This Trial?

This trial is for men and women aged 18 or older who are classified as ASA status 1-4, indicating they're healthy enough for anesthesia. It's not suitable for those under 18, or patients who can't or won't undergo a comprehensive airway examination.

Inclusion Criteria

I am either male or female.

My health status is rated between 1 to 4 on the ASA scale.

Exclusion Criteria

I am unwilling to undergo a thorough airway examination.

I cannot undergo a detailed airway examination.

I am under 18 years old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preoperative Assessment

Participants undergo a comprehensive preoperative airway examination using a 75-degree rigid laryngoscope and traditional airway tests

1 day

1 visit (in-person)

Follow-up

Participants are monitored for any immediate postoperative airway complications

1 week

What Are the Treatments Tested in This Trial?

Interventions

• Endoscopic Examination

Trial Overview The study is testing the effectiveness of a new method called CPAG using a rigid laryngoscope to predict difficulties with intubation during anesthesia, comparing it against the traditional Mallampati test.

How Is the Trial Designed?

Group I: Study Group Experimental Treatment 1 Intervention

Participants will undergo a endoscopic airway assessment in addition to the airway classification using the Mallampati score.

Endoscopic Examination is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:

Approved in European Union as Endoscopy for:

• Diagnostic examination of the upper gastrointestinal tract
• Therapeutic interventions such as biopsy and polyp removal

Approved in United States as Endoscopy for:

• Diagnosis and treatment of gastrointestinal disorders
• Screening for esophageal, stomach, and duodenal cancers

Approved in Canada as Endoscopy for:

• Investigation of symptoms such as dysphagia, abdominal pain, and bleeding
• Monitoring of chronic conditions like gastroesophageal reflux disease

Approved in Japan as Endoscopy for:

• Early detection of gastric cancer
• Treatment of gastrointestinal bleeding and obstruction

Approved in China as Endoscopy for:

• Diagnosis of gastrointestinal diseases
• Therapeutic procedures like variceal ligation and stenting

Approved in Switzerland as Endoscopy for:

• Comprehensive evaluation of the upper GI tract
• Interventional procedures such as dilation and stenting

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

Published Research Related to This Trial

A new grading system for the complexity of endoscopic procedures was established through consensus voting among gastroenterologists in the US, Canada, and Britain, categorizing procedures from level 1 (easiest) to level 4 (most difficult).

This consensus list aims to enhance the understanding of procedure complexity, complementing existing lexicons for adverse events and risk factors, although it is based more on expert opinion than empirical evidence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Grading the complexity of endoscopic procedures: results of an ASGE working party. Cotton, PB., Eisen, G., Romagnuolo, J., et al.[2022]

The complication rates for gastrointestinal endoscopy procedures are low, with upper gastrointestinal endoscopy having a complication rate of about 0.1% and colonoscopy at 0.2%, indicating that these procedures are generally safe when performed by experienced professionals.

Risk factors such as advanced age, chronic obstructive pulmonary disease, and the need for premedication should be carefully considered to minimize complications, and monitoring patients during and after the procedure is crucial for safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Complications of diagnostic gastrointestinal endoscopy. Hart, R., Classen, M.[2022]

Iatrogenic perforations during upper gastrointestinal endoscopy are rare, occurring in only 28 out of 149,792 procedures (0.019%), with a higher risk associated with specific procedures like esophageal endoscopic submucosal dissection (10.7%).

Most electrocoagulation-induced perforations can be effectively managed with endoscopic clips, while blunt trauma-induced perforations carry a higher risk of mortality, necessitating prompt surgical intervention if endoscopic closure fails.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical outcomes of iatrogenic upper gastrointestinal endoscopic perforation: a 10-year study. Kang, DH., Ryu, DG., Choi, CW., et al.[2020]

In a study of 2320 upper endoscopies performed on patients with upper gastrointestinal bleeding, the overall complication rate was 0.9%, which included 12 major complications and 9 minor complications.

There were 3 deaths linked to major complications, all occurring in patients with severe underlying health issues, indicating that while endoscopy carries risks, these are consistent with other studies in similar patient populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

National ASGE survey on upper gastrointestinal bleeding: complications of endoscopy. Gilbert, DA., Silverstein, FE., Tedesco, FJ.[2020]

Virtual endoscopy (VE) significantly improves the diagnostic accuracy of airway assessments in patients with head and neck pathology, which is crucial for predicting difficult intubation.

Incorporating VE into the assessment process helps formulate safer and more effective airway management strategies, potentially reducing complications in this high-risk patient group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhancing airway assessment of patients with head and neck pathology using virtual endoscopy. Ahmad, I., Keane, O., Muldoon, S.[2022]

Endoscopic examination is a valuable but invasive procedure for diagnosing and treating alimentary tract diseases, with potential complications that can arise both from preparation and during the procedure itself.

Preventing complications involves careful patient selection, thorough medical history review, proper preparation, and ensuring that experienced staff conduct the procedure in a well-equipped setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Complications of endoscopy in children]. Krzesiek, E., Iwańczak, B.[2008]

In a study of 374 anesthetics, including 252 with preoperative transnasal videoendoscopy (TVE), the use of TVE significantly improved the prediction of difficult videolaryngoscopic intubation compared to traditional assessments, enhancing the accuracy of the Simplified Airway Risk Index (SARI).

Specific findings from TVE, such as lesions on the vestibular folds and epiglottis, as well as the degree of visibility of the rima glottidis, were identified as important indicators that could alert anesthetists to potential difficulties during intubation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nasendoscopy to Predict Difficult Videolaryngoscopy: A Multivariable Model Development Study. Sasu, PB., Pansa, JI., Stadlhofer, R., et al.[2023]

Flexible endoscopic examination of swallowing, with or without sensory testing, is a very safe and portable procedure that effectively diagnoses aspiration compared to traditional videofluoroscopy.

This technique is particularly useful for identifying laryngopharyngeal sensory deficits, which are linked to issues like cough and reflux, making it a valuable tool in the assessment of patients with swallowing disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Flexible endoscopic evaluation of swallowing with sensory testing. Rees, CJ.[2006]

In a study of 5,680 patients undergoing fiberoptic endoscopic evaluation of swallowing (FEES), the procedure was found to be well tolerated, with a low incidence of serious complications, primarily involving discomfort and gagging.

Complications such as anterior and posterior epistaxis, vasovagal crises, and laryngospasm were rare, with specific risk factors identified including chronic gastrointestinal diseases and neurodegenerative conditions, indicating that while FEES is generally safe, certain patient populations may require closer monitoring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Complications during Fiberoptic Endoscopic Evaluation of Swallowing in 5,680 Examinations. Nacci, A., Simoni, F., Pagani, R., et al.[2022]

In a review of 3033 upper gastrointestinal endoscopy requests, only 74.3% adhered to the American Gastrointestinal Endoscopy Society guidelines, indicating a significant gap in appropriate use.

Despite the low adherence to guidelines, 56.3% of the endoscopies revealed abnormal findings, but only 46.8% of these findings matched the initial clinical diagnoses, suggesting potential issues in diagnostic accuracy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Appropriate use of diagnostic esophagogastroduodenoscopy and its relation with positive results]. Trujillo-Benavides, OE., Navarro-García, AM., Guerrero-Hernández, MM.[2015]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9806027/

Complications of diagnostic upper Gastrointestinal ... Perforation at upper GI endoscopy is a potentially life-threatening complication, with mortality rates of 2%–36% for oesophageal perforation.

2. asge.org asge.org/docs/default-source/education/practice_guidelines/doc-adverse-events-of-upper-gi-endoscopy.pdf

Adverse events of upper GI endoscopy This document is based on a critical review of the available data and expert consensus at the time that the document was drafted.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10948266/

Upper gastrointestinal endoscopy procedure volume trends ... Other complications include bleeding and esophageal perforation, which occurs in only 0.03% of diagnostic EGDs . More invasive procedures, such ...

4. withpower.com withpower.com/trial/phase-7-2021-2bacd

Endoscopic Airway Examination for Predicting Intubation ... Endoscopic Examination is unique because it allows direct visualization of the airway, which can help predict complications during intubation, especially in ...

5. psnet.ahrq.gov psnet.ahrq.gov/web-mm/sudden-collapse-during-upper-gastrointestinal-endoscopy-expect-unexpected

Sudden Collapse During Upper Gastrointestinal Endoscopy The most common complications of endoscopy are bleeding, bowel perforation, infection, and reactions to administered medications.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5042313/

Performance measures for upper gastrointestinal endoscopy This paper describes the first performance measures generated by evidence-based consensus that can be used for UGI endoscopy.

7. giejournal.org giejournal.org/article/S0016-5107(03)70115-1/fulltext

Endotracheal intubation for airway protection during ... Patients with upper GI (UGI) bleeding are at especially high risk for cardiopulmonary complications because of aspiration of blood and/or gastric contents and ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S1052515718303647

Complications of Upper Gastrointestinal Endoscopy The mortality rate is estimated to be between 0.5 and 3 per 10,000 cases. Cardiopulmonary events comprise 50% of all major complications, and most of these ...