Highlight
This article presents the design, development, and clinical evaluation of a novel transoral device—the Orocannula—engineered via 3D printing to simultaneously deliver oxygen and monitor carbon dioxide (CO2) during sedation.
Key highlights include the device’s resistance to flow obstruction under external compression, compatibility with existing nasal oxygen cannula tubing, and a high retention rate without displacement during surgery.
Study Background
Procedural sedation, frequently used in a wide range of minimally invasive surgeries, carries inherent risks of respiratory compromise, including hypoventilation and oxygen desaturation. Continuous monitoring of ventilation via CO2 measurement and oxygen delivery is essential to prevent hypoxemia and related complications. Conventional nasal cannulas primarily deliver oxygen but have limited or no ability to reliably monitor expiratory CO2, especially when patients breathe through the mouth. Addressing this gap, a transoral device that integrates oxygen delivery and capnography could enhance airway management and patient safety during sedation.
Study Design
The study involved the engineering of a novel device, the Orocannula, using computer-aided design and 3D printing with thermoplastic polyurethane (TPU), a flexible and biocompatible material commonly used in medical devices. The prototype was designed to accommodate standard oxygen cannula tubing. Preclinical flow testing assessed oxygen flow rates under baseline conditions and with the application of an external 3 kg mass to simulate compression.
Subsequently, a clinical evaluation enrolled twenty adult patients undergoing surgery under sedation. Participants had a mean age of 65.8 years, and 60% were female. The primary outcome measures included intraoperative oxygen saturation and end-tidal CO2 values, device stability, and the need for repositioning or adjustments during the procedure. The average duration of surgeries was 52.7 minutes.
Key Findings
The preclinical testing demonstrated that conventional oxygen cannula tubing was susceptible to flow obstruction under external compression, with mean flow dropping significantly (to 0.04 L/min) when a 3 kg mass was applied (p < 0.01). In contrast, oxygen flow through tubing integrated into the Orocannula showed no significant difference from baseline (mean ~3.57 L/min, p = 0.43) and was unaffected by the same external load (mean ~3.66 L/min, p = 0.52).
Clinical outcomes were encouraging: all patients completed their procedures with satisfactory respiratory parameters. The mean oxygen desaturation nadir recorded was 94.8% (SD ± 2.9), indicating preserved oxygenation during sedation. Notably, the device remained securely in place without any dislodgement or need for repositioning in 75% of cases, reflecting a stable fit during operative conditions.
There were no reported adverse events related to device use, underscoring its safety and feasibility in a perioperative context.
Expert Commentary
The integration of a transoral CO2 monitoring element coupled with oxygen delivery in a single device is a significant advancement for sedation-related airway management. Traditional nasal cannulas can be ineffective if patients breathe predominantly through the mouth or if fit is compromised. The Orocannula’s design appears to overcome these limitations by providing a secure oral route that allows simultaneous oxygen delivery and capnography monitoring.
The use of 3D printing with TPU offers rapid prototyping and customization possibilities, making this device adaptable for various patient anatomies and procedural requirements. However, the current study is limited by a relatively small sample size and single-center design; broader trials are warranted to confirm generalizability and long-term performance.
Additionally, integration with existing monitoring systems and workflow, as well as patient comfort assessments over longer procedures, remain areas for further research.
Conclusion
The Orocannula represents a promising innovation in airway device technology for patients undergoing sedation. It provides reliable oxygen delivery and CO2 monitoring with minimal risk of flow obstruction and high retention during procedures. Its compatibility with standard nasal cannula tubing allows for easy adoption without necessitating entirely new equipment.
Although preliminary data are favorable, further multicenter studies with larger cohorts and diverse procedural contexts are necessary to establish its role in routine anesthetic practice. This device has the potential to enhance patient safety by providing more accurate respiratory monitoring and oxygenation support during sedation, addressing a critical unmet clinical need.
Funding and ClinicalTrials.gov
The report does not specify funding sources or clinical trial registration information.
References
- Oyer SL, Thornton N, Epps M, Hassan K, Sande W, Mandava S, Thames M, Gutierrez C. Design and Development of Novel Airway Device for Transoral Respiratory Monitoring During Sedation. The Laryngoscope. 2026 Jul 9. PMID: 42423283.
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