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Efficacy of a 3D-Printed Facemask With Detachable Nasal Cannula for Apneic Oxygenation During Intubation in Adult Patients

A Prospective Randomised Controlled Study To Evaluate The Efficacy Of A Novel 3D Printed Facemask With An Integrated And Detachable Nasal Cannula For Providing Apneic Oxygenation By Assessing Arterial PartialPressure Of Oxygen During Larygoscopy And Intubation In Adult Patients Undergoing Surgical Procedures Under General Anaesthesia - Nil

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/05/087336
Enrollment
80
Registered
2025-05-21
Start date
Unknown
Completion date
Unknown
Last updated
2025-05-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: Novel 3D Printed Facemask with Integrated and Detachable Nasal Cannula: The investigational device is a novel, low-cost 3D printed facemask incorporating an integrated and detachable na

Sponsors

Saveetha Medical College And Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Adult patients aged 18-50 years Scheduled for elective surgery requiring general anesthesia American Society of Anesthesiologists physical status classification I-III

Exclusion criteria

Exclusion criteria: Patients with anticipated difficult mask ventilation Nasal obstruction or recent nasal surgery. Low oxygen saturation preoperatively Pre-existing pulmonary diseases Patient refusal to participate in the study

Design outcomes

Primary

MeasureTime frame
The novel device will maintain higher PaO2 levels at the end of the apneic period compared to the conventional method, indicating better preservation of oxygen levels during the apneic phase. Timepoint: At baseline

Secondary

MeasureTime frame
We expect to prove that the novel device provides both good preoxygenation & apneic oxygenation with a single device. The device will show a more effective reduction in PaCO2 levels during the apneic period than the conventional approach at baseline Timepoint: At baseline

Countries

India

Contacts

Public ContactYachendra

Saveetha Medical College And Hospital

dr_yach@yahoo.co.in9790963362

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026