Comparison Between Nasal and Oropharyngeal Bleeding in Video Laryngoscopy and Direct Laryngoscopy for Nasal Intubation

Not Applicable

Recruiting

• Conditions: Nasal Bleeding; Maxillofacial Injuries; Intubation Complication

• Registration Number: NCT06386757
• Lead Sponsor: Aswan University

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study First Submitted: 2024-04-04
• Study First Submitted QC: 2024-04-24
• Study First Posted: 2024-04-26
• Status Verified: 2024-05
• Study Start: 2024-06-01
• Primary Completion: 2025-01-01
• Last Update Submitted: 2025-02-20
• Last Update Posted: 2025-02-21
• Study Completion: 2025-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 64

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Incidence of nasal and oropharyngeal bleeding	Through study completion, average 60 minutes at 5, 15, 30 minutes	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)

Secondary Outcome Measures

Name	Time	Method
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	Time of successful intubation, defined as the time from removal of mask ventilation and beginning of bougie insertion until inflation of tube cuff
Overall rate of first trial success.	Within minutes	Overall rate of first trial success.
The use of magill forceps	Within minutes	The use of magill forceps

Trial Locations

Locations (1)

Aswan University; 🇪🇬 Aswan, Egypt