An interventional study of Combined Video Laryngoscopy (VL) and Bougie and Combined Direct Laryngoscopy (DL) and Bougie in Maxillofacial Injuries, Nasal Bleeding and Intubation Complication, sponsored by Aswan University. Recruiting at 1 site in Egypt. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-02-21.
Sponsored by Aswan University · Not applicable, Interventional, and Prevention
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
Maxillofacial fractures occur in a significant proportion worldwide and can occur as an isolated injury or in combination with other severe injuries including cranial, spinal, and upper and lower body injuries requiring prompt diagnosis with possible emergency interventions. The epidemiology of facial fractures varies with regard to injury type, severity, and cause and depends on the population studied.
Traumatic maxillofacial fractures are known to have difficulty in airway management due to anatomical and functional reasons. In many situations, treatment of facial fractures requires tracheal intubation. For fractures that involve occlusion, such as mandibular and Lefort fractures, oral intubation inhibits appropriate resolution of the occlusion. In these situations, nasotracheal intubation is indicated.
Direct laryngoscopic (DL) nasal intubations may be challenging if there is altered airway anatomy, difficulty in advancing the endotracheal tube through the glottis or in providers who are in training or those with less experience, even for patients with normal airway anatomy. The presence of cervical spine injury limit neck extension and makes airway manipulation more difficult. The use of Magill forceps is not always successful and is associated with endotracheal tube cuff damage and postoperative pharyngitis.
Video laryngoscopy (VL) is an adjunctive technique in anesthesia that utilizes a camera at the tip of the laryngoscope blade, which provides an indirect view of the glottis and surrounding structures during intubation displayed on a monitor. Use of video laryngoscopes has been shown to result in higher first intubation success, better laryngoscopic views, less mucosal trauma.
A bougie that is a long, stiff plastic wand is required to direct the tube to the glottis through manipulation through nasal route. bougie overcame the limitations of endotracheal tube direction and provided an advantage of rail-roading the tube over the bougie under vision leaving no possibility of trauma caused by direct or magill forceps tube manipulation.
Epistaxis is the most common complication encountered during nasotracheal (NT) intubation and may have serious consequences, such as lifethreatening bleeding and airway obstruction by aspirated blood. In addition, it may occur even when mucosal vasoconstriction, a lubricated tracheal tube and careful manipulation of the tube during insertion are employed.
22 studies on the registry are indexed under Maxillofacial Injuries; 7 are open to participants now.
This study's planned enrollment of 64 is above the median of 28 across 10 interventional studies indexed under Maxillofacial Injuries.
Browse Maxillofacial Injuries studies →Aswan University is the lead sponsor of 47 studies on the registry; 21 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Group Ι Combined Video Laryngoscopy (VL) and Bougie: Nasal intubation will be performed using a video laryngoscope and a bougie.
Nasal intubation will be performed using a traditional direct laryngoscope and a bougie.
Procedure: Combined Direct Laryngoscopy (DL) and Bougie
To compare combined video laryngoscopy and bougie versus direct laryngoscopy and bougie for nasal intubation.
To compare combined video laryngoscopy and bougie versus direct laryngoscopy and bougie for nasal intubation
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) 1. Minimal bleeding ( not a nuisance to vision , no suctioning required) 2. Mild bleeding (a nuisance to vision but does not compromises laryngeal tube insertion, occasional suctioning required ) 3. Moderate bleeding (slightly compromises laryngeal tube insertion, frequent suctioning required) 4. Severe bleeding (significantly compromises laryngeal tube insertion, frequent suctioning required) 5. Massive bleeding (cannot insert laryngeal tube, constant suctioning required)
Time frame: Through study completion, average 60 minutes at 5, 15, 30 minutes
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
Time frame: Within minutes
Overall rate of first trial success.
Overall rate of first trial success.
Time frame: Within minutes
The use of magill forceps
The use of magill forceps
Time frame: Within minutes
Plan to share: No
Ran from Jun 2024 to primary completion in Jan 2025, 7 months.
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