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

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

Study Overview

• Status: Recruiting
• Conditions: Intubation Complication; Maxillofacial Injuries; Nasal Bleeding
• Intervention / Treatment: Procedure: Combined Video Laryngoscopy (VL) and Bougie; Procedure: Combined Direct Laryngoscopy (DL) and Bougie

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 Type: Interventional
• Enrollment (Estimated): 64
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Soudy S Hammad, MD; Phone Number: +201014761523; Email: soudi.salah@aswu.edu.eg
• Study Contact Backup: Name: Mohammed E Yahia, MSc; Phone Number: 01125257916

Study Locations

• Egypt
  • Aswan, Egypt, 81528
    • Recruiting
    • Aswan University
    • Contact: Soudy S Hammad, MD; Phone Number: +201014761523; Email: soudi.salah@aswu.edu.eg
    • Contact: Mohammed E Yahia, MSc; Phone Number: 01125257916
    • Contact: Mohammed A Alazhary, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group Ι Combined Video Laryngoscopy (VL) and Bougie; Group Ι Combined Video Laryngoscopy (VL) and Bougie: Nasal intubation will be performed using a video laryngoscope and a bougie.	Procedure: Combined Video Laryngoscopy (VL) and Bougie; To compare combined video laryngoscopy and bougie versus direct laryngoscopy and bougie for nasal intubation.
Active Comparator: Group ΙI Direct Laryngoscopy (DL) and 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Overall rate of first trial success.	Overall rate of first trial success.	Within minutes
The use of magill forceps	The use of magill forceps	Within minutes

Collaborators and Investigators

• Sponsor: Aswan University
• Investigators: Principal Investigator: Mohammed A Alazhary, MD, Aswan University; Principal Investigator: Ayman M Eldemrdash, MD, Aswan University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2024
• Primary Completion (Actual): January 1, 2025
• Study Completion (Estimated): March 1, 2025

Study Registration Dates

• First Submitted: April 4, 2024
• First Submitted That Met QC Criteria: April 24, 2024
• First Posted (Actual): April 26, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 20, 2025
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: nasal intubation; videolaryngscopy; direct laryngscopy; bogie stylet
• Additional Relevant MeSH Terms: Nervous System Diseases; Wounds and Injuries; Pathologic Processes; Respiratory Tract Diseases; Nose Diseases; Otorhinolaryngologic Diseases; Signs and Symptoms, Respiratory; Craniocerebral Trauma; Trauma, Nervous System; Facial Injuries; Epistaxis; Hemorrhage; Maxillofacial Injuries
• Other Study ID Numbers: Asw.U. 911/3/24

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No