Background
Difficult airway generally refers to a clinical situation in which healthcare providers skilled in airway management experience difficulty using one or more standard airway management methods [
1]. There is no standardized definition of the difficult airway, and available expert guidelines vary between countries. The 2022 American Society of Anesthesiologists Guidelines defines a difficult airway as “a conventionally trained anesthesiologist experiences difficulty with facemask ventilation of the upper airway, difficulty with tracheal intubation, or both [
2].” Some definition is broader: “an experienced provider anticipates or encounters difficulty with any or all of face mask ventilation, direct or indirect (e.g., video) laryngoscopy, tracheal intubation, SGD (supraglottic device) use, or surgical airway [
3].” For difficult airway patients, tracheal extubation is a high-risk stage of anesthesia. Most problems that occur during extubation and removal are minor, but a small and significant number can result in injury or death [
4]. In response to this issue, the 1998 and 2005 Italian Guidelines [
5], 2013 ASA Practice Guidelines [
6], Canadian Guidelines [
7], and the Difficult Airway Society extubation Guidelines [
4] all discussed using airway exchange catheters (AECs) as part of a “safe extubation protocol.”
In addition to the AEC-based safe extubation strategy, Cook Medical has developed a new tool: Cook Stage extubation Set (CSES; Cook Intensive Care Unit; Bloomington, IN, USA). As an advanced version of AEC technology, CSES also allows for a phased extubation method. The CSES provides a guide wire that remains in place after extubation to maintain airway access and a reintubation catheter that can provide a catheter through the guide wire to track the tracheal tube or deliver oxygen through a central channel. By allocating corresponding marks on the endotracheal tube, depth marks are provided to facilitate correct and safe positioning. The staged principle of CSES is that the guide wire can be left in place to minimize side effects and improve patient compliance and that a dedicated hollow AEC (with absolutely little or no clearance from the endotracheal tube) can be used when reintubation is required.
The first large sample observational study of CSES was published in 2013, demonstrating the technique’s reliability and ease of use in adult patients with airway difficulties, with a reintubation failure rate of 13.8%. However, the authors also suggest that the risk of airway injury and complications (pneumothorax) associated with CSES is significant [
8]. Currently, no meta-analysis has been published in this area. Therefore this study aimed to review the clinical success rate, safety, and tolerability of CSES in patients with a difficult airways.
Discussion
This single-arm systematic review and meta-analysis is the first study to analyze the success rate and safety of CSES as an extubation tool in patients with a difficult airway. We included 714 difficult airway patients using CSES as an extubation tool. Several significant findings were observed from the meta-analysis results. As the primary and secondary outcome, CSES has achieved a high clinical success rate in adult and pediatric patients with different physical conditions and types of surgery. All original studies and meta-analyses confirmed a remarkably high tolerance rate and low overall complication rate. From the results of subgroup analysis and linear regression analysis, it can be inferred that the study’s higher heterogeneity and potential publication bias may result from the differences in the number of centers and study design of the original study. Loss or displacement of guidewire due to difficulty fixing is the main cause of CSES extubation failure and intolerance. Although the complication rate appears acceptable, CSES may increase the user’s risk of airway injury or pneumothorax.
CSES is a kind of hollow semi-rigid oxygen supply catheter, which is used in tube exchange or extubation tests because its catheter tip is blunt, which reduces the risk of tracheobronchial injury or lung tear [
23]. Unlike conventional jet-ventilated catheters, airway management may be easier and safer for anesthesiologists because CSESs can be used for endotracheal intubation through a catheter as a guide needle, can be connected with a typical circuit, an injector for high-frequency jet ventilation, or monitor end-tidal CO2 adapter through a RAPI-FIT® adapter [
24]. Different types and sizes of CSESs are produced, and the anesthesiologist can select the appropriate CSESs for the case for effective airway management during anesthesia. In addition, in terms of implantation mode, studies have evaluated the dislocation rate of transoral or intranasal AECs and have not shown significant differences between transoral and intranasal approaches.
Subgroup analysis and linear regression explain some of the reasons for the heterogeneity of the original study through quantitative data. Usually, well-designed multicentre studies may have more rigorous requirements for the execution of CSES operations, and the data integrity may be higher in prospective studies. Thus, CSES show higher clinical success rates in these studies. In addition, the difference in the definition of the clinical success rate of CSES is also the main cause of heterogeneity. Three of the included studies defined CSES success as successful intubation. McLean et al. described CSES success as complete trachea tube change on time. And Corso et al. defind CSES success as able to reintubate. Besides, none of the seven patients in the systematic review had reintubation. The original intention of staged extubation of CSES is to ensure the success rate and safety of extubation and reintubation for patients with airway difficulties to the greatest extent. However, the current result can only prove CSES’s high intubation success rate. Corso et al. reported that the CSES reintubation failure rate in difficult airway patients was 33.3%, which remains quite more elevated than the results from the study also recruited regular intubation patients (25%) [
14]. Considering the high reintubation and low reintubation success rates in patients with a difficult airway, future studies should pay more attention to the success rate and safety of CSES used for reintubation.
Current studies of CSES have a relatively small sample size, so overall complication reporting rates are low. However, the increased risk of airway injury and pneumothorax due to CSES use is a common problem reported by multiple studies. A recent review showed that 80% (95% CI, 69–88) of patients with airway intubation had no injury. Oedema is the most common mild injury, with prevalence ranging from 9 to 84%. Vocal cord hematoma is the most common moderate injury, with a prevalence of 4% (95% CI, 2–10). Overall, laryngeal injuries from short surgical intubations are common and usually mild. Screening for speech difficulties and dysphagia after extubation may help identify injuries [
25]. For pneumothorax caused by CSES. Case report studies speculate that the presence of endotracheal exchangers can significantly reduce the cross-sectional area and impairs passive exhalation, leading to air retention and consequent barotrauma. In addition, the tip of the exchange catheter may wedge into the bronchi, thus preventing air escape [
17]. In response to this hypothesis, combined barometric trauma can be reduced by reducing airway pressure during jet ventilation, providing longer exhalation times, and selecting an appropriately sized exchange catheter, all of which prevent air retention [
26].
Based on the available evidence, the experience we can share is that unrecognized oesophagal intubation events should be identified and prevented among the high reintubation situation in difficult airway patients. Recommendations such as exhaled carbon dioxide monitoring and pulse oxygen saturation measurement, video laryngoscope use, detecting the presence of “persistent exhaled carbon dioxide”; carry out cross-professional education programs can be used by all airway professionals in the prevention of unrecognized oesophagal intubations [
27]. At the same time, although relatively safe and effective auxiliary reintubation tools such as CSES have entered clinical application, considering the risk of airway injury and intubation failure caused by reintubation, the venturi mask or even better high-flow nasal oxygen cannula (HFNC) may be the better choices for inexperienced airway practitioners. It has been proved that both venturi masks and HFNC may help icu extubation patients achieve better oxygenation [
28]. High Flow nasal oxygen cannula may also achieve even lower rates of intubation [
29]. This is beneficial to the oxygen supply of patients after extubation and the formulation of a reintubation plan.
In conclusion, CSES is a safer and more feasible intubation tool for patients with clinical airway difficulties. However, compared with tool selection, the importance of developing a safe strategy for intubation and extubation before surgery, as well as the anesthesiologist’s proficiency and familiarity with the guidelines, has been emphasized in all studies.
Limitations
This study has some inventive new findings and some limits. First, the included number and the sample size of this meta-analysis were small, and the selection of patients in the original study had significant differences in their characteristics, preoperative physical conditions, and type of surgeries. Besides, due to the absence of patients’ basic information in some of the original studies, it is difficult to determine the source of inter-study heterogeneity. Second, the lack of a control arm. Since the clinical efficacy and safety studies of CSES are still at a relatively preliminary stage, the number of relevant works of literature is small, and no RCTS have been published. This meta-analysis based on single-arm studies is intended to point out the direction for future research. The caveat to establishing controlled trials in these settings is that it is difficult to recruit patients due to the severity of their condition in patients with difficult airways requiring surgery, which will result in underpowered studies. In addition, conducting controlled trials under such painful conditions may raise ethical questions related to surgical success rates and postoperative complications.
Publisher’s Note
Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.