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

200 Participants Needed

Trial Summary

What is the purpose of this trial?

Purpose of study: To contrast and compare the Mallampatti test to a comprehensive airway grading test using a rigid 75-degree angle laryngoscope (CPAG) Study Hypothesis: The investigators hypothesize that the CPAG will have greater sensitivity and specificity for predicting difficulty laryngoscopy as compared to the Mallampati test. The investigators plan to test this hypothesis by comparing the correlation of (a) airway Mallampati airway grading (predicted airway difficulty) versus (b) CPAG view grading and Cormack Laryngoscopy assessment (observed airway difficulty).

Will I have to stop taking my current medications?

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

Is endoscopic airway examination generally safe for humans?

Endoscopic procedures, like upper gastrointestinal endoscopy, are generally safe but do carry some risks. Complications are rare, occurring in about 0.1% to 0.9% of cases, and can include perforation (a tear in the organ), bleeding, or reactions to medication. Most serious complications are more likely in patients with severe underlying health issues. ^{1 2 3 4 5}

How is the Endoscopic Examination treatment unique for predicting intubation complications?

Endoscopic Examination is unique because it allows direct visualization of the airway, which can help predict complications during intubation, especially in patients with head and neck issues. This approach is more precise than traditional methods, as it provides a detailed view of the airway, potentially reducing the risk of unexpected difficulties during intubation. ^{6 7 8 9 10}

Research Team

Michael Froelich, MD, MS

Principal Investigator

University of Alabama at Birmingham

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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 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]

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]

References

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

Grading the complexity of endoscopic procedures: results of an ASGE working party. [2022]

2. Germany pubmed.ncbi.nlm.nih.gov

Complications of diagnostic gastrointestinal endoscopy. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Clinical outcomes of iatrogenic upper gastrointestinal endoscopic perforation: a 10-year study. [2020]

4. Mexico pubmed.ncbi.nlm.nih.gov

[Appropriate use of diagnostic esophagogastroduodenoscopy and its relation with positive results]. [2015]

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

National ASGE survey on upper gastrointestinal bleeding: complications of endoscopy. [2020]

6. India pubmed.ncbi.nlm.nih.gov

Enhancing airway assessment of patients with head and neck pathology using virtual endoscopy. [2022]

7. Poland pubmed.ncbi.nlm.nih.gov

[Complications of endoscopy in children]. [2008]

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

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

9. Switzerland pubmed.ncbi.nlm.nih.gov

Nasendoscopy to Predict Difficult Videolaryngoscopy: A Multivariable Model Development Study. [2023]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Complications during Fiberoptic Endoscopic Evaluation of Swallowing in 5,680 Examinations. [2022]