INTRODUCTION
Flexible nasopharyngolaryngoscopy (F-NPLS) is an easyto-perform, informative office procedure [
1]. This diagnostic tool is utilized for examining the upper airway. F-NPLS, whether performed awake or under sedation, is particularly useful for assessing dynamic abnormalities of the upper airway and is widely practiced by otolaryngologists, anesthesiologists, and other specialties [
2]. Its popularity stems from the significant diagnostic information it provides in an office setting [
3]. The first medically functional fiber-optic scope was designed in 1963 by Hirschowitz, although the technology became prominent in the 1950s [
4]. This procedure is also known as fiber-optic nasendoscopy, F-NPLS, or flexible fiber-optic nasopharyngolaryngoscopy.
The office procedure of F-NPLS is generally comfortable for patients. However, in some cases, passing the flexible scope through the nasal cavity can be challenging. Forcefully pushing the scope without proper navigational skills can traumatize the nasal mucosa, leading to pain, minor mucosal trauma, or bleeding. This, in turn, may reduce patient cooperation and occasionally prompt the consultant to abandon the procedure. Additionally, since the F-NPLS is a delicate device (with an outer diameter of approximately 3.2 mm) that contains sensitive fiber-optics, bending or forcefully pushing the stem or tip of the scope against a fixed structure can permanently damage the endoscope system. Patient factors such as a deviated nasal septum, spur, and turbinate hypertrophy can also contribute to difficulties in smoothly passing the scope during endoscopy. Unlike procedures using rigid nasal endoscopes, the intra-nasal trajectories for F-NPLS are not standardized [
5]. This lack of standardization hinders the teaching and learning process when training in this newly introduced procedure. Therefore, defining clear scope negotiation trajectories from one landmark to another would aid both trainers and trainees in communication. This could facilitate easier intra-nasal passage of the scope with minimal discomfort to the patient.
We undertook this study to determine the better trajectory for the intranasal passage of F-NPLS and to analyze patient/practitioner-related outcomes.
METHODS
This study was designed as a prospective, randomized, double-blind, single-center, parallel-group investigation. Prior to its initiation, approval was obtained from the Institutional Ethics Committee (IEC/Pharmac/49/20). The study was registered prospectively with the Clinical Trial Registry of India (REF/2021/03/042125) before the first patient was enrolled. A patient information sheet was completed, and written consent was obtained from each participant. A total of 114 patients, of either sex and aged between 2 and 80 years, who were scheduled to undergo F-NPLS under local anesthesia, were enrolled in the study. Patients with a history of bleeding disorders or those receiving anticoagulants or similar medications were excluded from the study.
This study was conducted in the Department of Otorhinolaryngology-Head and Neck Surgery at a tertiary care teaching center over a period of 2 years and 4 months.
Intervention
A postgraduate trainee in the department conducted thorough clinical examinations on all patients enrolled in the study. Patients were randomized into two groups, group A and group B, using a computer-generated random number table and the opaque sealed envelope method, with the process overseen by a nursing officer. An ENT surgeon performed the diagnostic F-NPLS and documented the outcomes as authorized by the research cell. For group A patients, the intranasal scope negotiation trajectory followed the route below the middle turbinate (black track) (
Fig. 1). In contrast, for group B patients, the trajectory used was along the inferior turbinate (red track). The same ENT surgeon performed the F-NPLS procedure on patients in both groups.
F-NPLS procedure
All patients underwent F-NPLS under local anesthesia. Before the procedure, the nasal cavity on the roomier side was packed with cotton patties soaked in a 4% lidocaine (Xylocaine) solution and xylometazoline nasal drops for 5 minutes. An Olympus Rhino-Laryngo Fibrescope (Olympus, Tokyo, Japan) camera and light source system with a 3.2 mm flexible NPLS without a channel was used. The procedure was performed with the patient in a supine position and the practitioner standing at the head end of the table. After anesthetizing and decongesting the nose for 5 minutes, the scope tip was positioned along the septum at the nasal valve region (
Fig. 2A). The joystick of the scope was used to direct the tip for flexing and retroflexing. In group A, the scope was directed toward the middle turbinate, stopping short of the anterior end, and later negotiated in the space below the lower surface of the middle turbinate (
Fig. 2B) until its posterior attachment to the lateral wall. It was then directed toward the choana (
Fig. 2C). In group B, the F-NPLS scope was directed toward the anterior end of the inferior turbinate (
Fig. 3A), further negotiated in the nasal cavity space between the septum and the medial surface of the inferior turbinate (
Fig. 3B). Finally, it was directed toward the posterior choana (
Fig. 3C). F-NPLS was completed for evaluating the nasopharynx, oropharynx, larynx, and laryngopharynx as usual.
Definition of primary and secondary outcomes
The objectives of the study were to evaluate patient comfort and practitioner satisfaction. The primary outcome assessed is the unhindered negotiation of the scope on its first passage. Secondary outcomes, including patient-perceived pain, the incidence of mucosal trauma, and reattempted scopy, were evaluated and recorded by the practitioner.
Images of F-NPLS were captured at specific landmarks. Information about outcomes is recorded at the conclusion of the procedure. Any need to withdraw the F-NPLS due to loss of orientation, poor visibility, or patient discomfort is documented as an attempt requiring a repeat F-NPLS (second/third). Patient-perceived pain, measured on a 10-point visual analog scale (VAS), is also recorded at the end of the procedure.
Statistical analysis
A total of 111 patients were included to account for any inadvertent data attrition. Patient demographic characteristics are summarized using means (standard deviations) and frequencies with percentages. The primary outcome, successful F-NPLS on the first attempt, was analyzed using the chi-square test. Similarly, provider comfort, assessed by whether the procedure was completed on the first or a subsequent attempt and the occurrence of mucosal injuries, was also evaluated using the chi-square test. Differences in perceived pain between the groups were measured using the independent t-test, while the distribution of pain based on the number of attempts and types of mucosal injuries was compared using one-way ANOVA. All statistical analyses were conducted using Stata (Version 14.0; Stata Corp., College Station, TX, USA). Statistical significance was established at a p-value of less than 0.05, with exact p-values provided for each comparison.
RESULTS
A total of 114 patients were recruited for the study. Three patients were excluded due to ongoing treatment with antiplatelet medication for underlying medical conditions. The remaining 111 eligible patients were randomized into group A (n=53) and group B (n=58). All participants successfully completed the study. Patient characteristics such as age and sex are detailed in
Table 1, while outcome measures, including attempts for unhindered scope negotiation, pain, and incidence of mucosal trauma, are presented in
Table 2.
Primary outcomes
In total, 111 patients were randomized into two groups: group A (n=53) and group B (n=58). There was no significant difference between the groups in terms of unhindered scope negotiation (p=0.8). Unhindered scope negotiation was possible in 28 subjects from group A (52.8%) and 32 subjects from group B (55.2%) (
Fig. 4).
Secondary outcomes
The incidence of scopy without mucosal trauma was significantly higher in group B (33 [56.9%]) compared to group A (19 [35.9%]) (p=0.004). Mucosal ecchymosis was more commonly encountered in group A (22 [41.5%]) than in group B (8 [13.8%]). However, nasal bleeding was more commonly observed in group B (17 [29.3%]) than in group A (12 [22.6%]). No significant difference was observed in perceived pain between group A, with a VAS score mean (SD) of 4.8 (1.2), and group B, with a VAS score mean (SD) of 4.9 (2.0) (p=0.8). However, pain significantly increased with the number of attempts and the occurrence of mucosal injuries (
Fig. 5).
DISCUSSION
The results of the present study underscore that understanding the intranasal trajectories of F-NPLS is beneficial for safer and more effective scopy. Additionally, subsequent reattempts following an unsuccessful F-NPLS are likely to result in a poorer experience for both the patient and the practitioner.
The F-NPLS procedure is performed under local anesthesia using topical lidocaine in the form of a solution, spray, or gel to reduce discomfort [
6]. Typically, trained and senior consultants can evaluate the entire upper airway in less than 2 minutes. Studies have shown that there is no significant difference in pain and discomfort between using spray and cotton patties for topical anesthetic preparation [
7]. The intranasal mucosa, which is richly supplied by sensory and autonomic nerves, is extremely sensitive. Patient experiences can range from mild discomfort to pain. Additionally, the procedure can lead to increased secretion and engorgement of the nasal cavernous mucosa of the turbinate, reducing the available space and tolerance for the procedure. Achieving cooperation during the procedure is particularly challenging in the pediatric age group [
8]. Anatomic variations, such as a deviated nasal septum or spur, further increase sensitivity when inadvertently touched by the tip or stem of the scope during forceful negotiation. De Boer et al. [
9] recommended oral insertion for non-sedated bronchoscopy with a bronchoscope larger than 6.0 mm when there is no need to inspect the upper airways, as they compared oral and nasal insertion methods.
The insertion of a flexible scope involves flexing and retroflexing the tip of the scope while pushing the stem forward to advance inside the nasal cavity. The necessary hand-eye coordination is a skill that the practitioner develops over time through practice. Conversely, the risk of nasal mucosal trauma is reduced with a rigid sinoscope, as the practitioner does not need to alter the position of the scope’s tip. Traditionally, diagnostic nasal endoscopy with a 4 mm rigid sinoscope is routinely employed in the preoperative evaluation of patients with nasal obstruction to examine hidden areas such as the middle meatus and superior meatus [
10]. The standard teaching for rigid nasal endoscopy has defined landmarks and trajectories for sinoscope movements within the nasal cavity. This standardization facilitates clear communication between the trainee and the trainer, enhancing effective scope negotiation.
The variability in current practices among those performing F-NPLS may indicate uncertainty about what constitutes best practice for this procedure [
11]. To perform any procedure or surgery safely and effectively, knowledge of surgical landmarks is crucial. This knowledge not only aids in teaching trainees who are new to the procedure but also facilitates a smoother and quicker execution of the procedure without the need for repetition. The two trajectories described in this study are supplementary; with complete knowledge, one can use them according to intranasal anatomical variations to enhance the overall experience.
The use of artificial intelligence (AI), machine learning, and robotics within the medical community is continually increasing. AI-supported robotics are already prominent in operating rooms [
12]. Highly infectious respiratory diseases may eliminate the need for specific types of sampling without human intervention in the future. Preparing for similar future needs justifies the establishment of precise standardized data collection methods that can be input into the system to generate algorithms [
13].
In the present study, unhindered scope negotiation occurred more frequently in group B than in group A. However, this difference was not statistically significant (p=0.08), suggesting that both trajectories individually offer better prospects for safe and effective scopy. Additionally, when the practitioner is knowledgeable about the trajectory, the chances of successful scopy on the first attempt are improved.
The incidence of scopy without mucosal trauma was significantly higher in group B (33 [56.9%]) compared to group A, likely due to the relatively straighter trajectory that does not require flexing or retroflexing the scope tip. However, mucosal ecchymosis was more commonly observed in group A (22 [41.5%]) than in group B (8 [13.8%]), which may be attributed to the narrow passage between the septum and the medial surface of the inferior turbinate. Nasal bleeding was more frequent in group B (17 [29.3%]) than in group A (12 [22.6%]), as the tip and stem were in contact with the underside of the middle turbinate, which is covered by a thin layer of mucoperiosteum over the bone, unlike the thick mucosa covering the inferior turbinate.
We acknowledge the potential limitations of this study, including its small sample size and the fact that F-NPLS was performed by the same ENT surgeon for both groups. Future research could benefit from a larger sample size and a multicentre comparative study to analyze reproducibility.
In conclusion, the present study demonstrated that the success rate of unhindered F-NPLS was comparable between the two trajectories. However, patients experienced moderate to severe pain during repeat scopy compared to the initial F-NPLS attempt.