Overview

This trial is active, not recruiting.

Condition difficult intubation
Treatment photographing head and neck
Sponsor Tufts Medical Center
Start date May 2012
End date June 2017
Trial size 310 participants
Trial identifier NCT01612949, IRB#9929

Summary

The aim of this project is to develop a computer algorithm that can accurately predict how easy or difficult it is to intubate a patient based upon digital photographs from three different perspectives. Such an application can provide a consistent, quantitative measure of intubation difficulty by analyzing facial features in captured photographs - features which have previously been shown to correlate with how easy or how hard it would be to perform the intubation procedure. This is in contrast to established subjective protocols that also serve to predict intubation difficulty, albeit with lower accuracy. A digital application has the potential to decrease potential complications related to intubation difficulty and increase patient safety.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
photographing head and neck
Taking three photographs of head and neck-one photograph from front, one from left and one fron right. The photographs are analyzed by facial structure software to create face model.
photographing head and neck
Taking three photographs of head and neck-one photograph from front, one from left and one fron right. The photographs are analyzed by facial structure software to create face model.
photographing head and neck
Taking three photographs of head and neck-one photograph from front, one from left and one fron right. The photographs are analyzed by facial structure software to create face model.
photographing head and neck
Taking three photographs of head and neck-one photograph from front, one from left and one fron right. The photographs are analyzed by facial structure software to create face model.

Primary Outcomes

Measure
Computer algorithm to predict difficulty of endotracheal intubation
time frame: Approximately 1 year, based on current enrollment pattern

Eligibility Criteria

Male or female participants from 18 years up to 64 years old.

Inclusion Criteria: - Patients requiring endotracheal intubation - Patients consenting to acquisition of photographic images of the head and neck Exclusion Criteria: - Patients who had undergone head or neck surgery - Patients in whom central venous catheters or other interventions that prevent full view of the features of the face in frontal and profile views - Patients who were neither easy nor difficult to intubate by our criteria

Additional Information

Official title Comparison of a Computerized Image Analysis to Conventional Airway Examination Techniques to Predict Difficult Endotracheal Intubation
Principal investigator Scott Segal, MD, MHCM
Description Both control and experimental cohorts will be recruited in this study. In order to drive clinical acceptance of this technique, the investigators will need to study and then demonstrate applicability to all patients regardless of race or gender. This will require the recruitment of a control population of patients who have been demonstrated at surgery to be easy to intubate. Such patients are in relative abundance. The experimental group will consist of patients who are found at surgery to be difficult to intubate. Patients are defined as easy to intubate if their anesthetic record described a single attempt with a Macintosh 3 blade resulting in a grade 1 laryngoscopic view (full exposure of the vocal cords). Difficult intubation was defined by at least one of: more than one attempt by an operator with at least one year of anesthesia experience, grade 3 or 4 laryngoscopic view on a 4 point scale, 5 need for a second operator, or non-elective use of an alternative airway device such as a bougie, fiberoptic bronchoscope or intubating laryngeal mask airway. The primary purpose of the study is to develop algorithms capable of discriminating patients who are likely to be difficult to intubate from those who are likely to be easy to intubate based on facial appearance. The primary analysis is the demonstration of statistical significance in the ability of the derived algorithms to determine successfully whether a subject was easy or difficult to intubate. A secondary analysis is the demonstration of a statistical difference in performance between the derived algorithms versus conventional airway assessment tests.
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by Tufts Medical Center.