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Accès ouvert déclaré 2026 preprint

HBCH Varanasi ETT Securement Scaffold (VESS): An Open-Source Hardware Scaffold for Endotracheal Tube and Nasogastric Tube Securement in Critically Ill Patients

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The HBCH Varanasi ETT Securement Scaffold (VESS) is an open-source bedside-fabricated scaffold designed to assist secure fixation of endotracheal tubes (ETT) and nasogastric tubes (NGT) in critically ill patients requiring prolonged mechanical ventilation or enteral feeding support. Poject DOI: https://doi.org/10.17605/OSF.IO/2KES7 The device is fabricated from a medical-grade fenestrated low-temperature thermoplastic material sheet, softened in warm water, cut into a simple rectangular configuration with a central isthmus, molded to the patient’s facial contours over soft tissue paper after application of an alcohol-free silicone skin barrier spray, and secured using cotton tape ties. The central isthmus provides a structured region for securing ETT and NGT using cotton tape, with optional medical-grade adhesive tape reinforcement for rigid free-side knots. The intended advantages are simplicity, low cost, bedside adaptability, same-patient remolding when facial contour changes occur, and reduction of dependence on expensive commercial tube holders. Safety instructions include daily inspection of skin contact points, immediate removal if pressure injury develops, single-patient use only, and same-patient remolding/reuse only when clinically appropriate. The uploaded VESS design sheet specifies approximate material cost in India in 2026 as ₹50–100 per device, with raw material availability through Government e-Marketplace sources. The project is released as Open Source Hardware under CC BY-NC 4.0, permitting free clinical replication while prohibiting commercial use. Primary Designer / Author / Copyright Holder Prof. (Dr.) Jyotirmay Kirtania Professor MPMMCC & HBCH, Varanasi Tata Memorial Centre Department of Atomic Energy, Government of India Homi Bhabha National Institute, India This project is released as open-source hardware under the Creative Commons Attribution–NonCommercial-ShareAlike 4.0 International License. Free clinical replication, teaching, and non-commercial use are permitted with attribution to the designer. Commercial use is prohibited. Hardware Classification Open-source clinical hardware / bedside-fabricated non-powered tube securement scaffold Intended Use Statement The VESS scaffold is intended to support secure fixation of endotracheal tubes and nasogastric tubes in critically ill patients requiring prolonged mechanical ventilation or enteral feeding support. It is intended for use by trained clinical personnel in ICU or high-dependency settings, with appropriate skin protection, daily skin inspection, and clinical judgment. The VESS scaffold is not intended as: A substitute for clinical airway vigilance. A guarantee against accidental extubation or tube displacement. A reusable device across different patients. A commercial product unless separately evaluated, licensed, and approved through applicable regulatory pathways. A device to be used over injured, infected, fragile, burned, ulcerated, or pressure-damaged facial skin without specialist clinical judgment. Materials Required Medical-grade fenestrated low-temperature thermoplastic sheet Thickness: approximately 2–3.2 mm Fenestration: up to approximately 22% Example material: Lyza3D Polycast or equivalent Steel set square Cutting board Precision cutting knife Scissors Warm water bath, approximately 60–70°C Alcohol-free silicone barrier spray, e.g., Esenta Skin Barrier Spray or equivalent Soft tissue paper Cotton tape ties Optional: small segment of medical-grade adhesive tape for rigid free-side knots Fabrication Summary Start with a rectangular low-temperature thermoplastic sheet. Soften the sheet in warm water at approximately 60–70°C until pliable. Cut the scaffold into a rectangular design with a central isthmus. Apply alcohol-free silicone barrier spray to the patient’s facial skin. Place a single layer of soft tissue paper over the cheeks. Mold the warm VESS scaffold to the patient’s facial contours. Attach two pairs of cotton tape ties on each side: One pair at superior zygomatic level above the ear. One pair at inferior mandibular level below the ear. Secure all four lateral ties. Secure the ETT and NGT to the central isthmus using cotton tape ties. Inspect skin-contact points daily. Design Dimensions from Current Version Overall scaffold dimensions: 100 mm × 240 mm Central cut-out: 80 mm length × 12 mm width Isthmus width: 8 mm These dimensions are based on the current uploaded design sheet and may require modification based on patient facial anatomy, age, edema, tube position, local material stiffness, and clinical context. Safety Statement The VESS scaffold must be used with daily skin-integrity monitoring at all contact points. It should be removed immediately if pressure injury, skin discoloration, blistering, pain, edema-related compression, or tissue compromise develops. The scaffold is for single-patient use only. It may be reheated, remolded, and reused for the same patient if the patient’s facial contour changes because of edema or reduction in swelling. Infection Prevention Statement The scaffold should be fabricated and handled using clean clinical technique according to local infection prevention policy. It should not be transferred between patients. If visibly contaminated, structurally damaged, or clinically unsafe, it should be discarded and replaced. Cost Statement The approximate material cost in India in 2026 is ₹50–100 per device, excluding labour, institutional sterilization or cleaning workflow costs, wastage, packaging, and quality assurance overheads.

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