Comparing video and direct laryngoscopy for nasal intubation in facial injury patients
Comparison Between Nasal and Oropharyngeal Bleeding in Video Laryngoscopy and Direct Laryngoscopy for Nasal Intubation in Maxillofacial Trauma Patients: a Randomized Controlled Trial
This study is testing whether using video laryngoscopy is safer and more effective than direct laryngoscopy for nasal intubation in patients with facial injuries.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 64 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Aswan University Academic / other |
| Locations | 1 site (Aswān, Aswan Governorate) |
| Trial ID | NCT06386757 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness and safety of video laryngoscopy compared to direct laryngoscopy for nasal intubation in patients with maxillofacial fractures. It focuses on measuring outcomes such as bleeding to oral and nasal structures, intubation times, success rates for first attempts, and the need for additional tools like Magill forceps. The study will include patients undergoing maxillofacial surgeries requiring nasotracheal intubation, specifically targeting those with ASA I/II classifications and a BMI under 35. By comparing these two techniques, the study seeks to identify which method provides better airway management in this challenging patient population.
Who should consider this trial
Good fit: Ideal candidates for this study are patients undergoing maxillofacial surgeries who require nasotracheal intubation and are classified as ASA I or II with a BMI less than 35.
Not a fit: Patients with bleeding disorders, those on anticoagulant medications, or those with anticipated difficult airways may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved airway management techniques for patients with maxillofacial injuries, reducing complications and enhancing patient safety.
How similar studies have performed: While there is ongoing research in airway management techniques, this specific comparison of video versus direct laryngoscopy for nasal intubation in maxillofacial injuries is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients who will undergo maxillofacial surgeries with nasotracheal intubation.. * ASA I/II patients. * BMI \<35 Exclusion Criteria: * Having bleeding diathesis and abnormal Prothrombin Time (PT), Partial Thromboplastin Time (PTT), or platelet counts. * Local causes of bleeding as adenoid * On medications that alter blood coagulation as anticoagulants and antiplatlets. * Patients in which either intubation failed on both nostrils or where intubation was only possible with a tube smaller than 6.0 mm internal diameter(ID). * Anticipated difficult airways. * ASA III/IV.
Where this trial is running
Aswān, Aswan Governorate
- Aswan University — Aswān, Aswan Governorate, Egypt (Recruiting)
Study contacts
- Principal investigator: Mohammed A Alazhary, MD — Aswan University
- Study coordinator: Soudy S Hammad, MD
- Email: soudi.salah@aswu.edu.eg
- Phone: +201014761523
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.