Recruiting

Observational Study

Sponsor:

Wake Forest University Health Sciences

Code:

NCT01612949

Conditions

Difficult Intubation

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

photographing head and neck

Study Details

Brief 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.

Conditions

Difficult Intubation

Study ID

NCT01612949

Start date

May, 2012

Status verified date

Mar, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

3500 participants

Anticipated

Interventions and Outcome Measures

Arms

easy to intubate, model derivation

easy to intubate, model derivation. photographing head and neck

difficult to intubate, model derivation

difficult to intubate, model derivation.photographing head and neck

easy to intubate, model validation

easy to intubate, model validation. photographing head and neck

difficult to intubate, model validation

difficult to intubate, model validation. photographing head and neck

Test

A group of unlabeled subjects (mix of easy and difficult intubations) to test the reproducibility of the derived and validated model(s)

Interventions

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 outcome measure

  • Computer algorithm to predict difficulty of endotracheal intubation [ Time Frame: Approximately 2 years, based on current enrollment pattern ]

Central Contacts and Locations

Central contacts

Scott Segal, MD, MHCM

(336) 716-7084B.Segal@wfusm.edu

Angela Goodson

336-716-4497agoodson@wakehealth.edu

Locations

Wake Forest Baptist Medical Center

Recruiting

Winston-Salem, North Carolina, United States, 27157

Contacts

Scott Segal, MD

336-716-4497

Principal Investigator:

Scott Segal, MD, MHCM

More Information

Sponsor

Wake Forest University Health Sciences

Last update posted

Apr 1, 2026

Last verified

Mar, 2026

Keywords

  • endotracheal intubation
  • facial structure
  • Mallampati score
  • computerized facial analysis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Wake Forest University Health Sciences on 2026-04-01.