Solving the problem of post-operative airway obstruction in Nasal/Sinus Surgery

Some surgeons choose not to place any packing. However, patients still complain of impaired breathing due to endonasal edema, blood and mucus accumulation. Nasal and Sinus procedures may feature some surgeoninserted “packing,” placed or injected into the nasal fossae, at the conclusion of the operation. In a National Interdisciplinary Rhinoplasty Survey, 39% of surgeons reported using packing 81%–100% of the time, with 81% of the surgeons leaving the packing in place for 0–3 days post-operatively [2].


Introduction
Sinus surgery, septoplasty-with or without turbinate reduction-and rhinoplasty are among the most common surgical procedures performed by our specialty. In 2006, 600,000 sinus surgeries were performed in the United States [1]. A recent paper reported more than 300,000 rhinoplasties done per year [1,2]. Septoplasties and ancillary procedures accounted for an additional 489,000 procedures [1].

Packing or no packing, the Post-operative period is not popular with patients
Some surgeons choose not to place any packing. However, patients still complain of impaired breathing due to endonasal edema, blood and mucus accumulation. Nasal and Sinus procedures may feature some surgeoninserted "packing," placed or injected into the nasal fossae, at the conclusion of the operation. In a National Interdisciplinary Rhinoplasty Survey, 39% of surgeons reported using packing 81%-100% of the time, with 81% of the surgeons leaving the packing in place for 0-3 days post-operatively [2]. • Act as a conduit for topical medications to be instilled after surgery (e.g., nasal decongestant drops to reduce bleeding and/or relieve congestion)

Patients fear the post-op experience more than the surgery
Today it is common knowledge among prospective patients that nasal and sinus surgery may require packing or that even if not, the post-operative experience is not ideal. Such historical "bad press" is not quickly erased. Even contemporary surgical patients, whose surgery did not include packing, still report post-op nasal blockage, which often requires intervention, as the single most burdensome feature of the surgery. Pain, easily controlled with analgesics, ranks lower on the list of negative memories.
Surgeons who favor packing have a variety of excellent packing products. Mesh, clothlike absorbables, gelliquids, or the non-absorbable, non-adherent, and easily removable Telfa varieties. In addition, there are new packing substances on the horizon, as bioscience is learning to impregnate the materials with biologicals that stimulate healing.
For those patients for whom packing is indicated, they report that the standard one-to-fi ve-day period of indwelling packing is the most unpleasant feature of the entire experience [3,4]. Tolerance levels among patients vary greatly, but whether " packed" or " unpacked", a blocked nasal airway can generates some anxiety and even claustrophobia. "It was as if someone left a clothespin on my nose and walked away," reported one unhappy patient.

A guaranteed post-op nasal airfl ow is the Win-Win for patient safety and comfort
Surgeons, tinkerers by nature, tend to fi xate on surgical technique, embrace novel technology, innovative instrumentation in the pursuit of patient safety, and improved surgical results and operating room effi ciency and economy.
But, perhaps tunnel vision has been developed as surgeons labor in the nasal tunnels. Are surgeons losing opportunities to provide more patients with successful operations because they have neglected to also focus on patient comfort and satisfaction? Perhaps, particularly because few have stood in the patient's shoes; "Every so often, a doctor needs to be a patient. He will then be a better doctor."

Are there prospective patients waiting on the sidelines?
Appreciating the face-off between post-operative safety and healing objectives -and comfort -we have examined the products and devices, past and present, that purport to facilitate nasal breathing after nasal/sinus surgery, whether the nose is packed or not. Some products, designed for dual packing-airway function, insinuate a pliable airway within a single piece of solid, foamlike packing material that expands when moistened ( Figure 1).
The veteran and popular "Doyle Septal Splint," rather than a one-piece packing/airway device, is a different variety of airway hybrid: it features pre-shaped and pre-sized soft silicone sheaths that act as septal splints ( Figure 2). While this combination of a removable septal splint and an attached intranasal airway is conceptually attractive, the functional reality is that the nasal airway in-situ always becomes blocked and thus inoperative. Early in the postoperative period, the narrow hemi-tubes promptly and irrevocably clog with blood and mucus. The deep-interior location effectively prohibits the patient or caretaker from gaining access to these anterior openings to keep the tubes from blocking. The air passage is now defunct.
A burden imposed upon the surgeon and staff is that the sutured-in-place Doyle requires an offi ce removal that is not a patient-favorite since the suture removal and delivery generates some discomfort as complete anesthesia is not attainable. Further, there is the additional time/labor cost to the practice. Many MDs delegate to their medical assistant or RN, but, their time is valuable also. As economic realities continue their pressure on MDs, effi ciency and economy of surgical care always has a consequence for the " bottomline".
The commonality to all deep-seated packing/airway hybrid devices -not just the Doyle -are locationbased, post-operative inaccessibility. Other dual-purpose, removable packing devices, as mentioned earlier, are the Pure Pak ® , Slik-Pak ® , and Venti-Pak ®. These products, into whose PVA foam bodies are seated a tube to ostensibly carry air, have been somewhat disappointing. Because immediately after surgery the nasal fossae quickly fi ll with secretions, the relatively narrow airfl ow tube can become blocked. Plus, their openings are not easily accessible for post-op, home-care maintenance.
We need to recognize that patients (who may be sedated by medications), and/or caregivers, are understandably reluctant to explore the nasal interior in the hope of re-opening blocked tubes and reestablishing functionality. Patients and their caregivers are justifi ably intimidated and fearful of causing pain or "ruining" the operation. Realistically, laypeople should not be charged with performing intranasal procedures to reopen an inoperative medical device.  An independent, single-purpose airway device is the best answer for satisfactory post-operative airfl ow and patient comfort We have studied, evaluated, and analyzed the defi ciencies and functional compromises of the dual-mission hybrids: the splint and airway and the packing and airway versions.
Perhaps it is better not to merge two disparate missions into a single device. For better performance and patient comfort and satisfaction, perhaps it is wiser to separate the splinting/ packing and airway roles.
Since there is now an ever-increasing variety of packing devices, it seems advantageous to allow the surgeon to choose from among them. For any of these modern packing products, a dedicated, independent, and reliable device to provide the post-operative airway is an ideal teammate.

A study of airfl ow through the new device versus through existing hybrid airways
The clinical value of any airway appliance rests on the volume of air that passes through the air tube en route to the lungs. Pouiseuille's Law*, which quantitates laminar airfl ow through a defi nable and measurable passage governs the analysis of nasal airway devices [5][6][7].
Poiseuille determined that the wider the tube radius, the lower the airfl ow resistance. More importantly, the change in radius is not proportional to the change in resistance but yields a four-fold increase in resistance for a given reduction in radius. Therefore, a small change in radius signifi cantly affects either fl ow rate or pressure drop required to achieve the same fl ow [8,9]. If the lumen of the airway becomes obstructed or narrowed, the effective radius of air fl ow will be signifi cantly reduced, negatively affecting air fl ow to the patient.   The photo below visually compares the lumena of the Doyle Septal Splint and the new nasal airway device Figure 5.
The Venti-Pak ® , a prototypical airway-packing hybrid, has an air tube inside diameter of 4 mm. Using Poiseuille's Law,the calculated airfl ow through a Venti-Pak ® is 82.5 cm 3 /pa-s. While delivering greater air fl ow than thru the Doyle Septal Splint, the Venti-Pak ® , also delivers more than 50% less air to the nasopharynx than the newer device Figure 6.
The tube is introduced at the conclusion of the operation prior to insertion of any packing, whether solid or gel. After initial, partial insertion, using a standard, thin-tip nasal speculum, inspect the nasal interior to ascertain the position of the airways within the nasal cavity Figure 7.
Under direct vision, advance the airways further into the nose. Next, using the inferior speculum blade or a bayonet forceps, direct each airway downward onto the fl oor. The tube will snap into place onto the fl oor of the nose and maintain that position, lateral to the pre-maxillary bone and medial to the inferior turbinate Figures 8-10.
After insertion and seating of the nasal airway, the surgeon passes the 10Fr plastic suction catheter through each tube and suctions fl uids from the pharynx. This maneuver also confi rms that the back opening of the device is unobstructed. Later, the anesthesia specialist, using the same fl exible suction catheter, will avail himself of this direct pathway to the pharynx for suctioning blood and mucous from throat.
At the end of the procedure, prior to awakening the patient, the same 10Fr. plastic suction catheter is passed by the anesthesiologist through each nasal airway tube to suction the oropharynx. Our anesthesiologists expressed preference for such access into the pharynx for suctioning while the patient is still asleep, rather than having to struggle to perform oralpharyngeal toilet, as the patient is emerging from anesthesia.

The clinical experience: 150 patient case histories
In the senior author's private practice, 150 patients scheduled to undergo reconstructive nasal surgery-nasal septoplasty and bilateral inferior turbinate resection, with or without rhinoplasty-were offered and consented to placement of the nasal airway.
In all septoplasty/turbinate cases, the senior author always inserted two different packings: one absorbable and one nonabsorbable ( Figure 12). The absorbable was a two-ply sheet of either gauzelike Surgicel ® or absorbable hemostatic gauze ActCel ® draped over the turbinate remnant. The removable pack was a folded (thus two-ply) single sheet of non-adherent Telfa ® coated on both sides with tetracycline ointment ( Figure   13). As a means to ease insertion of the absorbable packing (which becomes a bit unmanageable when moistened by mucus or blood), the ointment-coated, now surface-sticky Telfa ® pad was used to "carry and deliver" the gauze to its home over the medial edge of the turbinate (Figures 14-16). Then, the Telfa ® pad was placed against the septum to fulfi ll its overall packing mission. A remnant suture from the surgical procedure is secured to the right and left Telfa ® pads before insertion.
This was tied to its opposite member over the columella or

Analysis of patient experience
Of the 150 patients, 146 sustained the tube placement for one to six days after surgery. Typically, rhinoplasty-only patients require the airway for only 24 hours, the septoplasty/ turbinate patients with or without rhinoplasty patients are scheduled to have the airway and packing in place for fi ve days.
Three septoplasty/turbinate/rhinoplasty patients requested removal because they were not interested in, or capable of, the home irrigation of the tubes necessary to maintain patency and airfl ow. One septoplasty/turbinate/rhinoplasty patient took it upon himself to remove the airway after three days. No adverse consequences ensued from any premature removal.
Of those 146 patients whose airways remained in place the prescribed period of time, there was a subset of 33 patients who had previous surgeries with complete packing and no airway prior. One patient within this subgroup had three failed septorhinoplasty procedures. All 33 reported a positive experience with and preference for the nasal airway.
Of the remaining 113 study patients, there was a voluntary control group of 19. Those patients had identical packing placed  bilaterally, but one nasal passage also had place an airway tube.
All 19 reported preference for the "airway side" vs. the packedwithout-airway side.
Of the 94 patients with the routine, bilateral packing and bilateral airtubes in place, 91 reported a positive experience.
The overall patient satisfaction rate was 98%.

Conclusion
Though nasal and sinus surgery is common and widespread, there is no consensus on choice of nasal packing. Further some surgeons prefer not to pack. Those who pack feel that nasal packing-in some form-is important to prevent postoperative complications such as synechiae, bleeding, and anatomic destabilization.
Despite their importance and value, contemporary packing materials and devices and airway appliances generate patient dissatisfaction. Even those patients who do not endure packing are not satisfi ed with the airway immediately after surgery because of lining mucosal edema,and blood and mucus stasis. Pack or no-pack, nasal obstruction generates anxiety, claustrophobia, and negative public relations. For these routine and generally successful procedures to be rejected by patients because of post-operative dissatisfaction -which need not occur -is unfortunate. There are perhaps tens of thousands of potential patients who would be approaching nasal surgeons requesting the operation had the procedure's bad public image not scared them off.
As a result of investigating the issue of patient comfort and safety in the nasal/sinus surgery post-operative period, the new medical device described in this report provides a safe airway that contributes to patient comfort and, ultimately, provides a more satisfactory post-surgical experience.