AI-Integrated 3D-Printed Videolaryngoscope for Orotracheal Intubation in Critically Ill Patients
Starting soon · Not applicable
Conditions studied: Orotracheal Intubation
In brief
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.
Key facts
- Study ID
- NCT07592702
- Run by
- Federal University of Pelotas
- People needed
- 120
- Starts
- 2027-03-20
- Expected to finish
- 2028-06-01
- Last updated by the study team
- 2026-05-18
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
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.
Where it is running
- Husfp - Ucpel — Pelotas, Rio Grande do Sul, Brazil
- Ebserh/Ufpel — Pelotas, Rio Grande do Sul, Brazil
- Ebserh/Furg — Rio Grande, Rio Grande do Sul, Brazil
- Ebserh/Ufsc — Florianópolis, South Carolina, Brazil
Full record on ClinicalTrials.gov
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