Intubation Complication Clinical Trial
Official title:
Comparison Between Nasal and Oropharyngeal Bleeding in Video Laryngoscopy and Direct Laryngoscopy for Nasal Intubation in Maxillofacial Trauma Patients: A Randomized Controlled Trial
The objective of this study is to compare the effectiveness and safety of video laryngoscopy versus direct laryngoscopy for nasal intubation in patients with maxillofacial fractures regarding less bleeding to oral and nasal structures, quicker intubation times, increased success rates for first intubation attempts, fewer uses of the Magill forceps and the less need for cervical spine extension
Status | Recruiting |
Enrollment | 64 |
Est. completion date | January 1, 2025 |
Est. primary completion date | January 1, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Egypt | Aswan University | Aswan |
Lead Sponsor | Collaborator |
---|---|
Aswan University |
Egypt,
Kumar P, Sharma J, Johar S, Singh V. Guiding Flexible-Tipped Bougie Under Videolaryngoscopy: An Alternative to Fiberoptic Nasotracheal Intubation in Maxillofacial Surgeries. J Maxillofac Oral Surg. 2020 Jun;19(2):324-326. doi: 10.1007/s12663-020-01327-w. Epub 2020 Jan 24. — View Citation
Nedrud SM, Baasch DG, Cabral JD, McEwen DS, Dasika J. Combined Video Laryngoscope and Fiberoptic Nasal Intubation. Cureus. 2021 Nov 11;13(11):e19482. doi: 10.7759/cureus.19482. eCollection 2021 Nov. — View Citation
Prasant MC, Kar S, Rastogi S, Hada P, Ali FM, Mudhol A. Comparative Study of Blood Loss, Quality of Surgical Field and Duration of Surgery in Maxillofacial Cases with and without Hypotensive Anesthesia. J Int Oral Health. 2014 Nov-Dec;6(6):18-21. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of nasal and oropharyngeal bleeding | Incidence of nasal and oropharyngeal bleeding using Fromme's ordinal scale which is used for assessment of the surgical field quality( V Rajanigandha, et al. 2023),we will modify this scale to evaluate airway as follows :
0- No bleeding (virtually bloodless field) Minimal bleeding ( not a nuisance to vision , no suctioning required) Mild bleeding (a nuisance to vision but does not compromises laryngeal tube insertion, occasional suctioning required ) Moderate bleeding (slightly compromises laryngeal tube insertion, frequent suctioning required) Severe bleeding (significantly compromises laryngeal tube insertion, frequent suctioning required) Massive bleeding (cannot insert laryngeal tube, constant suctioning required) |
Through study completion, average 60 minutes at 5, 15, 30 minutes | |
Secondary | Time of successful intubation, defined as the time from removal of mask ventilation and beginning of bougie insertion until inflation of tube cuff | Time of successful intubation, defined as the time from removal of mask ventilation and beginning of bougie insertion until inflation of tube cuff | Within minutes | |
Secondary | Overall rate of first trial success. | Overall rate of first trial success. | Within minutes | |
Secondary | The use of magill forceps | The use of magill forceps | Within minutes |
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