Abstract
Objective
The use of aspirin in patients undergoing open tracheostomy is an issue for which there is still no clear conclusion. This uncertainty leads surgeons to make decisions based on the risks and benefits of continuing versus discontinuing aspirin. Therefore, this study aims to investigate complications related to aspirin use. The primary outcome was bleeding complications, while other complications were secondary outcomes.
Methods
This was a retrospective study compiling data from patients who underwent open tracheostomy at the Department of Otolaryngology, Faculty of Medicine, Chulalongkorn university and King Chulalongkorn Memorial Hospital, Thai Red Cross Society, between January 2019 and December 2023. Demographic data, medical conditions, indications for tracheostomy, surgeon characteristics, operative time, aspirin use status, and complications were reviewed.
Results
There were 47 patients in total in this study: 15 patients in the aspirin continuation group and 32 patients in the aspirin discontinuation group. In the aspirin continuation group, there were no major or minor bleeding events. In the discontinuation group, there were two cases of major bleeding and two cases of minor bleeding (an incidence of 6.3% for each), although the differences observed were not statistically significant. There were no other complications that showed statistically significant differences between the two groups.
Conclusion
This study has shown that low-dose aspirin (81 mg) does not increase the risk of bleeding or other complications in patients who undergo open tracheostomy. These results support that the continuation of aspirin may be safe in patients undergoing this procedure.
Introduction
Tracheostomy is a common surgical procedure that provides a safe airway by creating a direct opening into the trachea. Indications for tracheostomy include prolonged mechanical ventilation, upper airway obstruction, the need for pulmonary hygiene, and airway protection.1,2 There are two approaches: open and percutaneous tracheostomy. Although tracheostomy is a common procedure, complications are still frequently detected. Bleeding is one of the most common complications. 2 The incidence of postoperative bleeding has been reported to vary, but tracheostomy is generally defined as a high-risk bleeding procedure according to a 2013 New England Journal of Medicine study. 3
Aspirin 81 mg is commonly prescribed for primary and secondary cardiovascular prevention. The mechanism of aspirin is as an irreversible inhibitor of COX-1, which leads to a reduction in thromboxane A2 production, an important mediator of platelet aggregation and activation.2,4–8 Currently, information from other studies suggests that tracheostomy is safe in patients on dual antiplatelet therapy,6,9–12 while there is a lack of information on the management of patients taking only aspirin. Due to the absence of a gold standard, preoperative decision making about the continuation or discontinuation of antiplatelet therapy is personalized and based on the surgeon's experience, following principles regarding bleeding risk and thromboembolic events.
There is some information from previous research. For example, Markota et al. 6 found no significant difference in bleeding risk between patients on dual antiplatelet therapy and those not receiving antiplatelet therapy when undergoing open tracheostomy. Similarly, Zapata-Contreras et al. 11 reported increased bleeding complications in patients on dual antiplatelet therapy, though without associated mortality. Data on bleeding risk with open tracheostomy related to aspirin alone is lacking. Therefore, this study aims to evaluate bleeding and other complications in patients undergoing open tracheostomy while continuing to take aspirin 81 mg.
Materials and methods
A retrospective review was approved by the Institutional Review Board of the Faculty of Medicine, Chulalongkorn University (COA No.1160/2024). Data of patients who had undergone open tracheostomy at the Department of Otolaryngology, Faculty of Medicine, Chulalongkorn university and King Chulalongkorn Memorial Hospital, Thai Red Cross Society between January 2019 and December 2023 was collected from medical records. Patients were divided into two groups according to the use of aspirin in the preoperative period: Aspirin continued—patients who continued aspirin therapy during the entire perioperative period or whose aspirin therapy was discontinued for less than 7 days preoperatively. Aspirin discontinued: patients whose aspirin therapy was discontinued at least 7 days before surgery.
Patients aged 18 years or older who were taking aspirin 81 mg and undergoing open tracheostomy performed by the otolaryngology department at King Chulalongkorn Hospital were included in the study. On the other hand, patients who were currently taking other antiplatelet, anticoagulant, or antithrombotic medications; had a coagulopathy (defined as a platelet count < 80,000/µL, activated partial thromboplastin time (aPTT) > 50 seconds, or prothrombin time (PT) > 50% above the normal reference range13,14; were undergoing surgery apart from bronchoscopy, laryngoscopy, esophagoscopy, or biopsy; or had a diagnosis of hematological malignancy were excluded.
Clinicodemographic data for the two groups consisted of sex, age, indication for tracheostomy, comorbid conditions, surgeon's characteristics, operative time, smoking status, and alcohol consumption status. After reviewing the available medical records, 47 patients who met the inclusion criteria were identified. There were 15 patients who continued aspirin therapy and 32 who discontinued it. All 47 eligible patients were included in the outcome analysis.
Definitions
Low-dose aspirin was defined as aspirin administered at a dosage of 81 mg. Smoking was defined as smoking at least one pack per day and quitting less than 6 weeks before surgery. Alcohol use was defined as stopping alcohol consumption less than 4 weeks before surgery. Surgeons were categorized into two groups: qualified otolaryngologists, who were board-certified specialists, and nonqualified otolaryngologists, defined as otolaryngology residents in training years 1, 2, or 3. The primary outcome variable was bleeding events, divided into three categories: major bleeding, minor bleeding, and no bleeding. Bleeding was considered major if it resulted in a decrease of 3% in hematocrit, required a blood transfusion, caused hypotension or cardiac arrest, or necessitated surgical intervention to control the bleeding. Minor bleeding was a bleeding event that could be managed through a dressing change or minor external compression.15,16 Patients who did not meet the criteria for major or minor bleeding were defined as having no bleeding. Secondary outcomes consisted of other complications like pneumothorax and subcutaneous emphysema, diagnosed postoperatively with chest X-ray imaging. Loss of airway was defined as the inability to access the airway within 20 seconds after opening the trachea during the tracheostomy operation.2,17
The primary outcome for this study was bleeding events, which were categorized into three groups: major bleeding, minor bleeding, and no bleeding. Specific criteria for each category are described in the Definitions section. Secondary outcomes to assess the overall safety profile and surgical quality between the two groups were the incidence of other tracheostomy complications, including paratracheal insertion, pneumothorax, subcutaneous emphysema, airway fire, accidental decannulation, stomal infection, loss of airway, laryngotracheal stenosis, tracheomalacia, and tracheoesophageal fistula. The incidence of each complication was confirmed by a review of medical records and radiographic findings.
Statistical analysis
Patient demographic data were compared between the aspirin continuation and discontinuation groups using the Chi-square test for categorical variables and the Independent T-test for continuous variables. Both primary and secondary outcomes were analyzed and compared between the two groups using the Chi-square test. However, because the data did not follow a normal distribution, other statistical tests were ultimately used. For categorical variables with small sample sizes, Fisher's Exact Test was applied. For continuous variables, the Mann–Whitney U test was used. Statistical analyses were performed using SPSS software version 26 with a significance threshold set at p < 0.05.
Results
Clinicodemographic data
Table 1 presents the demographic and clinical characteristics of tracheostomy patients in the aspirin continuation (n = 15) and aspirin discontinuation (n = 32) groups. The median age was 72 years (interquartile range (IQR): 64, 87) in the aspirin continuation group and 78 years (IQR: 68, 85) in the discontinuation group, with no statistically significant difference (p = 0.599). Gender distribution was also comparable between the two groups, with males comprising 73.3% of the continuation group and 62.5% of the discontinuation group (p = 0.528).
Comparing clinicodemographic in tracheostomy patients who continued aspirin versus discontinued aspirin.
Fisher's exact and Mann–Whitney test; ASA: aspirin.
Significant differences were observed in tracheostomy indications. Upper airway obstruction was more common in the aspirin continuation group (46.7%) than in the discontinuation group (9.4%), showing statistical significance (p = 0.007). Conversely, prolonged intubation was a more frequent indication in the aspirin discontinuation group (75%) compared to the continuation group (33.3%) (p = 0.01).
No statistically significant differences were found between the groups regarding gender distribution, age, underlying diseases, surgeon type, operative time, smoking status, or alcohol consumption.
Primary outcome
The primary outcome, bleeding events, was evaluated in both the aspirin continuation and discontinuation groups, as shown in Table 2. Among patients in the aspirin continuation group (n = 15), no cases of major or minor bleeding were observed, resulting in a 100% rate of no bleeding events. In contrast, the aspirin discontinuation group (n = 32) had two cases (6.3%) of major bleeding and two cases (6.3%) of minor bleeding. Despite these observations, the differences in the rates of major and minor bleeding between the aspirin continuation and discontinuation groups were not statistically significant (p = 1.0 for both major and minor bleeding, Fisher's exact test).
Comparing bleeding outcome in tracheostomy patients who continued aspirin versus discontinued aspirin.
Fisher's exact test; ASA: aspirin.
Secondary outcome
The analysis of secondary outcomes included a range of tracheostomy-related complications, with findings summarized in Table 3. No instances of paratracheal insertion, pneumothorax, airway fire, loss of airway, or laryngotracheal stenosis were observed in either the aspirin continuation or discontinuation groups. Subcutaneous emphysema was reported in one patient (6.7%) within the aspirin continuation group, while no cases were recorded in the discontinuation group; this difference was not statistically significant (p = 0.319). Similarly, accidental decannulation and stomal infection each occurred in one patient (3.1%) in the aspirin discontinuation group, with no cases in the continuation group; neither difference reached statistical significance (p = 1.0 for both). Tracheomalacia was identified in two patients (13.3%) in the continuation group and in two patients (6.3%) in the discontinuation group, with no significant difference between groups (p = 0.583). Additionally, a tracheoesophageal fistula was observed in two patients (13.3%) in the continuation group and in none of the discontinuation group; this difference approached but did not reach statistical significance (p = 0.097).
Comparing secondary outcome in tracheostomy patients who continued aspirin versus discontinued aspirin.
Fisher's exact test; ASA: aspirin.
Overall, the incidence of secondary complications was comparable between patients who continued aspirin therapy and those who discontinued it, with no statistically significant differences observed.
Discussion
The primary outcome of this study was a comparison of bleeding complications in patients undergoing open tracheostomy while continuing or discontinuing low-dose aspirin therapy. Our findings showed that there was no significant increase in either major or minor bleeding events in the aspirin continuation group compared to the aspirin discontinuation group. There were no major or minor bleeding events found among patients in the aspirin continuation group, while in the aspirin discontinuation group, both major and minor bleeding events had an incidence of 6.3%. Additionally, there was no bleeding in the group using aspirin compared to 84.4% in the discontinuation group, although this was not statistically significant. These findings suggest that continuing low-dose aspirin at 81 mg does not significantly increase bleeding complications after open tracheostomy and that continuing aspirin is safe in patients undergoing this procedure. These findings are consistent with previous studies that have investigated the safety of antiplatelet and antithrombotic therapy in tracheostomy patients. Markota et al., 6 for example, examined morbidity and mortality rates related to open tracheostomy among patients undergoing dual antiplatelet therapy compared to those without antiplatelet therapy. The lack of a statistical difference in the incidence of postoperative morbidity and mortality between both groups allowed the authors to suggest that dual antiplatelet therapy does not affect outcomes in tracheostomy patients. Similarly, Zapata-Contreras et al. 11 presented the results of a descriptive study focused on bleeding complications in patients with open tracheostomy on dual antiplatelet therapy. While some patients in their cohort did experience major bleeding, these events did not impact mortality, suggesting that the risk of bleeding with antiplatelet therapy may not increase mortality in tracheostomy patients. Kennedy et al. 12 investigated the safety of continuing antithrombotic therapy, including antiplatelet and anticoagulant medications, during open tracheostomy. They did not find any statistically significant differences concerning postoperative bleeding in patients continuing versus not continuing antithrombotic therapy. Previous studies conclude that the continued perioperative use of antithrombotic agents does not increase bleeding complications and supports the idea that preoperative aspirin cessation is unnecessary and there is no need to delay tracheostomy.
Open tracheostomy is a common procedure in our medical center, and without clear standard practice guidelines, there is a belief that ceasing aspirin 7 days before surgery minimizes bleeding risk, which leads to delays in performing the tracheostomy. Delaying the tracheostomy to stop aspirin can cause several clinical and logistical problems. Delaying tracheostomy may increase complications, adversely affect quality of life, and raise healthcare costs; specifically, evidence suggests that every day of delay adds 1.31 days of ventilator dependence and extends the total hospital stay by 1.8 days.18,19 Early tracheostomy may decrease the risk of laryngotracheal stenosis, 2 reduce the need for sedation, 1 allow for early oral feeding, 2 promote patient mobility, 20 and reduce the incidence of various complications associated with mechanical ventilation.1,19,21 The results of our study indicate that continuing low-dose aspirin could allow for earlier timing of tracheostomy, reducing the need for delay due to antiplatelet management and thereby improving both patient outcomes and resource utilization. Our study observed no significant difference in complication rates between qualified and nonqualified otolaryngologist, a finding consistent with broader literature. While surgeon experience is a critical variable, prior studies indicate that supervised resident-performed tracheostomies are safe and comparable to those performed by attendings in terms of major morbidity.22–24
Regarding secondary outcomes, several tracheostomy-related complications were studied, and our study did not show any statistical differences between the aspirin continuation and discontinuation groups. Complications such as paratracheal insertion, pneumothorax, airway fire, and loss of airway were not found in either group, indicating these events were unaffected by aspirin therapy. Other complications, such as subcutaneous emphysema, accidental decannulation, stomal infection, tracheomalacia, and tracheoesophageal fistula, were infrequent and did not differ significantly between the two groups. Of note, tracheomalacia and tracheoesophageal fistula were found in two patients (13.3%) in the continuation group, without a significant increase compared with the discontinuation group. These findings support that the continuation of low-dose aspirin does not increase the risk of secondary complications in patients undergoing open tracheostomy. There was no significant difference in either bleeding or nonbleeding complications.
Limitations
This study has a few limitations that must be considered when interpreting the findings. First, because of the retrospective, single-center study design, there is an increased likelihood of selection bias. Second, because this study used medical records, the data might be incomplete or inconsistent due to individual documentation practices, which can lead to incomplete or unclear information. Since this study used past data, some clinicodemographic data or complications may not have been fully reported, which could affect the reliability of this study. Finally, although this study includes all tracheostomy patients who met the inclusion criteria at our center, the small sample size limits the study's statistical power. Therefore, this work should be considered a preliminary/pilot study.
Conclusion
This study demonstrates that continuing low-dose aspirin (81 mg) does not significantly increase the risk of bleeding or complications during open tracheostomy. These findings support the safety of maintaining perioperative aspirin to facilitate timely surgical intervention. However, given the limitations of this study, larger multicenter prospective trials are warranted to validate these results and guide clinical practice.
Footnotes
Ethical approval and informed consent statements
Ethical was approved by the Institutional Review Board of the Faculty of Medicine, Chulalongkorn University (COA No.1160/2024).
Funding
The authors received no financial support for the research, authorship, and/or publication of this article.
Declaration of conflicting interests
The authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.
Data availability statement
Data are available on request to corresponding author.
Reprint requests
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