Placing a percutaneous tracheostomy is common practice in intensive care units (ICU) in the Netherlands. This procedure is almost always performed by intensivists themselves. The percutaneous technique has many practical advantages and has replaced the surgical technique. Several studies have shown that the percutaneous technique is faster, safer, and cheaper than the surgical technique. The exceptions are a difficult airway, unfavorable anatomy (including abnormal neck vascularization, enlarged thyroid gland, morbid obesity) and burns in the neck, for which the surgical technique must be considered.

Summary of Findings

Population: Adult patients admitted to the ICU who are going to have a tracheostomy placed and who are intubated

Intervention: Percutaneous dilatational tracheostomy

Comparator: Surgical tracheostomy

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_{^1. Risk of Bias: serious. Due to study limitations.}

_{Imprecision: very serious. Due to overlap of the upper and lower limit of the 95% confidence interval with the minimal clinically important difference.}

_{^2. Risk of Bias: serious. Due to study limitations.}

_{^3. Risk of Bias: serious. Due to study limitations.}

_{Inconsistency: serious. Due to conflicting results and heterogeneity in the definition of the outcome measure.}

_{Imprecision: serious. Due to overlap of the lower limit of the 95% confidence interval with the minimal clinically important difference.}

_{^4. Risk of Bias: serious. Due to study limitations.}

_{Imprecision: very serious. Due to the optimal information size which was not achieved.}

Description of studies

A total of five studies were included in the analysis of the literature. Important study characteristics and results are summarized in table 2. The assessment of the risk of bias is summarized in the risk of bias tables (under the tab ‘Evidence tabellen’).

Battaglini (2022) performed a systematic review to assess the effect of surgical versus percutaneous tracheostomy in mechanically ventilated patients with COVID-19. PubMed, Embase, Scopus, and Cochrane were searched for all published observational studies between January 1, 2020 and January 10, 2022. Observational studies and randomized trials including 20 or more adult patients with suspected or confirmed SARS-CoV-2 infection who received a tracheostomy during their ICU course were included. In total, 47 observational studies were included.

The Cochrane review of Brass (2016) examined the effectiveness and safety of percutaneous techniques compared to surgical techniques for elective tracheostomy in critically ill adults and children. CENTRAL, MEDLINE, EMBASE, and CINAHL were searched until the 28^th of May 2015 for randomized and quasi-randomized controlled trials comparing percutaneous techniques with surgical techniques. In addition, reference lists of articles, ’grey literature’, dissertations, intensive care and anaesthesia journals, abstracts, and proceedings of scientific meetings were searched. Unpublished or ongoing studies were identified by contacting manufacturers and expertise in the field and searching in trial registers. Twenty studies were included.

Katial (2024) performed a randomized controlled trial to compare percutaneous dilation tracheostomy (PDT) with open surgical tracheostomy (ST) in critically ill patients. Patients aged ≥18 years with indication for tracheostomy were included. Thirty patients received PDT and 30 patients received ST. Groups were comparable at baseline.

Kim (2023) performed a randomized controlled trial to assess the safety and efficacy of ultrasound-guided PDT as compared to ST. Adult patients who required prolonged intubation, pulmonary hygiene, airway protection due to neurologic disease or traumatic brain injury, or adjunct tracheostomy to major head and neck surgery or airway obstruction were included. In total, 33 patients underwent PDT and 35 patients received ST. Groups were comparable at baseline.

Pandit (2023) performed a randomized controlled trial to compare PDT to conventional ST. Critically ill adult patients admitted to intensive care unit and subjected to tracheostomy either for prolonged intubation, airway protection or facilitation of weaning from ventilator (ventilator support) or pulmonary hygiene were included. Sixteen patients underwent PDT and sixteen patients underwent ST. Groups were comparable at baseline.

Table 2. Characteristics of included studies

_{*For further details, see risk of bias table in the appendix}

Results

1. Successful tracheostomy placement (critical)

Not reported.

2. Major complications (critical)

2.1. Intraoperative serious, life-threatening adverse events
Brass (2016) included twelve studies that reported intraoperative serious, life-threatening adverse events (Figure 1). This consisted of: major vascular injury or excessive bleeding (determined by the need for blood transfusion or an additional surgical procedure), tracheal or esophageal injury (detected by intraoperative bronchoscopy), loss of the airway (loss of the tube or tracheostomy cannula > 20 sec) or a misplaced airway (paratracheal insertion of the tube or the tracheostomy cannula), a severe hypoxic episode, or cardiac arrest. In total, 26 of the 634 patients (4.1%) who underwent percutaneous dilatational tracheostomy (PDT) had an intraoperative serious, life-threatening event as compared to 25 of the 577 patients (4.3%) who underwent surgical tracheostomy (ST) (RR=0.96, 95%CI 0.47 to 1.97). This difference is not clinically relevant.

2.2. Direct postoperative serious, life-threatening adverse events

Brass (2016) included ten studies that reported direct postoperative serious, life-threatening adverse events (Figure 1). This consisted of: major vascular injury or excessive bleeding (determined by the need for blood transfusion or an additional surgical procedure), a severe hypoxic episode, or saturation < 90%. In total, 19 of the 496 patients (3.8%) who underwent PDT had an intraoperative serious, life-threatening event as compared to 27 of the 488 patients (5.5%) who underwent ST (RR=0.66, 95%CI 0.30 to 1.45). This difference is clinically relevant favoring PDT.

_{Figure 1. Intraoperative and direct postoperative serious life-threatening adverse events}

2.3 Significant infection

Fifteen studies reported infection (Figure 2). Twenty-one of the 542 patients (3.9) who underwent PDT had an infection as compared to 89 of the 554 patients (16.1%) who underwent ST (RR=0.29, 95%CI 0.18 to 0.45). This difference is clinically relevant favoring PDT.

_{Figure 2. Infection}

2.4 Postoperative bleeding

Fifteen studies reported postoperative bleeding (Figure 3). Thirty-two of the 575 patients (5.6%) who underwent PDT had postoperative bleeding as compared to 45 of the 569 patients (7.9%) who underwent ST (RR=0.62, 95%CI 0.31 to 1.23). This difference is clinically relevant favoring PDT.

_{Figure 3. Postoperative bleeding}

COVID-19

Battaglini (2022) reported no differences in bleeding between PDT and ST (5.6% [95%CI: 2.0 to 9.1] versus 6.9% [95%CI: -1.6 to 15.4]; P=0.83; OR=0.9 [95%CI: 0.6 to 1.4]) for patients with COVID-19. Since no data was available about the number of participants, no GRADE assessment could be performed.

2.5 Procedural bleeding

Kim (2023) reported procedure-related estimated blood loss. Patients who underwent ultrasound-guided PDT had an estimated blood loss of 2.7 mL (SD=2.8) as compared to 2.1 mL (SD=2.1) for patients who underwent ST (MD=0.60 mL; 95%CI -0.58 to 1.78). This difference is not clinically relevant.

Pandit (2023) reported minimal and moderate peri-operative hemorrhage (not defined). Ten of the 16 patients (62.5%) who underwent PDT had minimal peri-operative hemorrhage as compared to 11 of the 16 patients (68.8%) who underwent ST (RR=0.91, 95%CI 0.55 to 1.50). Six of the 16 patients (37.5%) who underwent PDT had moderate peri-operative hemorrhage as compared to 5 of the 16 patients (31.3%) who underwent ST (RR=1.20, 95%CI 0.46 to 3.15). These differences were not clinically relevant.

2.6 Air leakage

Not reported.

2.7Airway loss

Not reported.

3. Tracheomalacia (important)

Not reported.

4. Stenosis (important)

Pandit (2023) reported that 1 of the 16 patients (6.3%) who underwent PDT had a tracheal stenosis, while this did not occur in patients who underwent ST.

A systematic review of the literature was performed to answer the following question(s):

What are the effectiveness and complications of percutaneous tracheostomy placement in adult patients admitted to the ICU compared to surgical tracheostomy placement?

Table 1. PICO

Relevant outcome measures

The guideline panel considered successful tracheostomy placement and major complications as critical outcome measures for decision making; and tracheomalacia and stenosis as important outcome measures for decision making.

The guideline panel defined the outcome measure ‘major complications’ as follows: airway loss, intraoperative and direct significant postoperative bleeding, significant hypoxia, a misplaced airway, pneumothorax, cardiac arrest, air leakage and significant infection. For the other outcomes, the guideline panel did not define the outcome measures but used the definitions used in the studies.

The guideline panel defined 25% difference (RR <0.8 to >1.25) for dichotomous and 0.5 SD for continuous outcomes as a minimal clinically (patient) important difference.

Search and select (Methods)

The databases Medline (via OVID) and Embase (via Embase.com) were searched with relevant search terms from 2000 until the 2^nd of August 2024. The detailed search strategy is listed under the tab ‘Literature search strategy’. The systematic literature search resulted in 636 hits. Studies were selected based on the following criteria:

• The study population had to meet the criteria as defined in the PICO
• The intervention had to meet the criteria as defined in the PICO
• Research type: systematic review, randomized-controlled trials or observational studies
• Articles written in English
• More than 10 patients per arm

Initially, 327 studies were selected based on title and abstract screening. First, the systematic reviews were screened. After reading thirteen systematic reviews in full text, eleven studies were excluded (see the exclusion table under the tab ‘Evidence tabellen’), and two systematic reviews were included (Battaglini, 2022; Brass, 2016). Then, the randomized controlled trials were screened from the search date of Brass 2016. After reading three randomized controlled trials in full text, no study was excluded and three studies were included (Katial, 2024; Kim, 2023; Pandit, 2023).