AI-Integrated 3D-Printed Videolaryngoscope for Orotracheal Intubation in Critically Ill Patients

NCT07592702 | Not Yet Recruiting DMC

• 1 other identifier: 406417/2024-5
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 4

Brief Summary

Background: Orotracheal intubation is an essential procedure in critically ill patients requiring ventilatory support, and the use of videolaryngoscopy is recommended as the gold standard in clinical practice. In recent years, the development of videolaryngoscopes through additive manufacturing has demonstrated lower production costs, and their integration with artificial intelligence (AI) has shown promising results in improving procedural success and safety. Aim: To evaluate the clinical performance and usability of a videolaryngoscope developed through additive manufacturing and integrated with artificial intelligence (AI) and computer vision, compared with a commercially available gold-standard videolaryngoscope. Methods: This is a multicenter, randomized, controlled, superiority Phase I/II clinical trial with a single-blind design. A total of 120 critically ill patients admitted to intensive care units at four hospitals in southern Brazil will be enrolled. Participants will be individually randomized in a 1:1 allocation ratio to parallel groups. The interventions will be performed by at least 10 physicians. All physicians will receive standardized training on device use, and procedures will be monitored by trained research staff. Data will be recorded in electronic Excel spreadsheets, and statistical analyses will be conducted using IBM SPSS Statistics. All ethical principles will be strictly observed, including obtaining informed consent from participants or their legal representatives. A Data and Safety Monitoring Committee will be established to oversee the study. Conclusions: If the expected results are confirmed, patients, healthcare professionals, and healthcare institutions may benefit from the improved performance, safety, and usability of the experimental device, particularly in critical care settings and public health emergencies.

Conditions

Orotracheal Intubation

Keywords

orotracheal intubation; videolaryngoscope; artificial intelligence; computer vision; additive manufacturing; medical device; clinical performance; usability

Outcome Measures

Primary Outcomes (4)

• Correct glottis visualization rate (%)

  Refers to the accurate visualization of the glottis and vocal cords on the VL monitor, in agreement with direct visualization - Cormack-Lehane Classification

  immediately after insertion of the videolaryngoscope

• First-attempt intubation success rate (%)

  Defined as the successful establishment of the artificial airway after a single insertion of the VL blade and orotracheal tube.

  immediately after the first intubation

• Number of attempts required for successful intubation (n)

  An attempt is defined as the insertion of the VL blade into the oral cavity, with successful intubation being the correct placement of the tube in the trachea. In the intervention group, up to three attempts with the AI-enhanced VL will be allowed.

  immediately after a successful intubation

• Conversion rate to conventional laryngoscope (%)

  Conversion is defined as the use of a conventional laryngoscope for intubation after discontinuing the use of the allocated VL (intervention or comparator).

  immediately after a failure to use the video laryngoscope

Secondary Outcomes (10)

• Connection time between VL and mobile software (seconds)

  Before intubation

• Glottis visualization time (seconds)

  within 60 seconds after insertion of the videolaryngoscope

• Orotracheal tube insertion time (seconds)

  within 60 seconds after intubation

• Total intubation time (seconds)

  within 60 seconds after intubation

• Adverse events and/or complications rate (%)

  during and immediately after intubation

Study Arms (2)

Videolaryngoscope 3D with artificial intelligence (VL-AI)

EXPERIMENTAL

Patients in the intervention group will receive the usual care for orotracheal intubation, differing only in the use of VLP-IA for opening and visualizing the upper airways.

Device: Orotracheal intubation using a 3D videolaryngoscope integrated with artificial intelligence (VL-IA).

Commercially available gold-standard videolaryngoscope (VL-C)

ACTIVE COMPARATOR

Patients in the comparator group will receive standard care for orotracheal intubation, using the gold-standard VLP-C for airway opening and visualization of the upper airways.

Device: Commercially available gold-standard videolaryngoscope (VL-C)

Interventions

Commercially available gold-standard videolaryngoscope (VL-C) DEVICE

Scientific evidence recommends the use of VL in all cases of intubation, across various clinical scenarios, as the primary intubation technique in clinical practice. The videolaryngoscope incorporates a microcamera at the tip of the blade, allowing visualization of anatomical structures in real time via a monitor.

Commercially available gold-standard videolaryngoscope (VL-C)

Orotracheal intubation using a 3D videolaryngoscope integrated with artificial intelligence (VL-IA). DEVICE

The videolaryngoscope (VL) incorporates a microcamera at the tip of the blade, enabling real-time visualization of anatomical structures via a monitor. The VL to be used in the intervention was manufactured through additive manufacturing using polylactic acid (PLA) and polyethylene terephthalate glycol (PETG). It was validated in high-fidelity simulations for mechanical strength and usability and is patented under number BR 10 2020 026194 with the Brazilian National Institute of Industrial Property (INPI). The VL is currently being enhanced through the integration of artificial intelligence (AI) using computer vision techniques based on Machine Learning and Deep Learning, including convolutional neural networks capable of automatically recognizing upper airway anatomical structures from previously trained image datasets. The embedded system will provide real-time visual and audio guidance during intubation with less than one-second latency.

Videolaryngoscope 3D with artificial intelligence (VL-AI)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient:
• Age ≥18 years.
• Both sexes.
• Clinical indication for orotracheal intubation.
• Physician:
• Both sexes.
• Working in emergency or ICU settings.
• Minimum of one year of experience in laryngoscopy and/or orotracheal intubation.

You may not qualify if:

• Patient:
• Clinically unstable or with contraindications to participation in experimental research.
• Significant airway malformations.
• Previously intubated or with a functioning tracheostomy.
• Pregnant.
• Physicians:
• On vacation or leave during the study period.
• Orthopedic, visual, or cognitive limitations that impair participation.

Sponsors & Collaborators

• Federal University of Pelotas: lead
• Universidade Federal de Santa Catarina: collaborator
• Universidade Católica de Pelotas: collaborator
• Universidade Federal do Rio Grande (FURG): collaborator

Study Sites (4)

Husfp - Ucpel

Pelotas, Rio Grande do Sul, 96020-220, Brazil

Location

Ebserh/Ufpel

Pelotas, Rio Grande do Sul, 96020-360, Brazil

Location

Ebserh/Furg

Rio Grande, Rio Grande do Sul, 96200-190, Brazil

Location

Ebserh/Ufsc

Florianópolis, South Carolina, 88040-370, Brazil

Location

Related Links

• Site

Study Officials

• Camila X Dalcól, PhD

  University Federal of Santa Catarina

  STUDY CHAIR

• Ines M Hirdes, Specialist

  University Catolic of Pelotas

  STUDY CHAIR

• Larissa O Daneluz, Master's degree

  University Federal of Santa Catarina

  STUDY CHAIR

• Andressa S Barboza, PhD

  University Federal of Santa Catarina

  STUDY CHAIR

• Marcelo C Ribeiro, Master's degree

  University federal of Pelotas

  STUDY CHAIR

• Tiago T Primo, PhD

  University Federal of Pelotas

  STUDY CHAIR

Central Study Contacts

Rafael G Lund, PhD

CONTACT

+55 (53) 99125-7668; rglund@ufpel.edu.br

Ana CBK de Moraes, PhD

CONTACT

+55 53 9176-9898; anacristinabkmoraes@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The statistician will be masked.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor PhD

Model Details: Phase II randomized clinical trial to evaluate the efficacy of the medical device. Validation with a device prototype will be performed prior to completion.

Study Record Dates

• First Submitted: April 17, 2026
• First Posted: May 18, 2026
• Study Start (Estimated): March 20, 2027
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): June 1, 2028
• Last Updated: May 18, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: Individual patient data (IPD) will be available at the time of publication of the study results (expected in 2028), for an indefinite period.
• Access Criteria: Individual patient data (IPD) will be accessible to researchers via a link that will be available along with the study results.

Locations

BR (4)