Publication

• Title: Effect of Early vs Late Tracheostomy Placement on Survival in Patients Receiving Mechanical Ventilation: The TracMan Randomized Trial
• Acronym: TracMan
• Year: 2013
• Journal published in: JAMA
• Citation: Young D, Harrison DA, Cuthbertson BH, Rowan K; TracMan Collaborators. Effect of early vs late tracheostomy placement on survival in patients receiving mechanical ventilation: the TracMan randomized trial. JAMA. 2013;309(20):2121-2129.

Context & Rationale

• Background

  • Tracheostomy was (and remains) commonly performed when clinicians predict prolonged invasive ventilation, with expected advantages over translaryngeal intubation (comfort, reduced sedative exposure, easier weaning, fewer airway complications, and possibly fewer infections).
  • Before TracMan, evidence to guide timing was limited, with practice variation (including early procedures) despite uncertainty about patient-centred benefits.
  • In the UK context of constrained ICU bed availability and high illness severity on admission, any intervention that could shorten ventilation/ICU stay had major implications for patients and system capacity.
• Research Question/Hypothesis

  • Does performing tracheostomy early (within 4 days of ICU admission) reduce mortality compared with deferring tracheostomy until day 10 or later and only if still clinically indicated, among adult ICU patients predicted to require prolonged mechanical ventilation?
• Why This Matters

  • Timing decisions trade off potential benefits (comfort, sedation reduction, ventilation/ICU duration) against procedure-related harms and resource use.
  • A high-quality, pragmatic RCT was needed to resolve conflicting prior data and to inform a common, high-impact ICU practice.

Design & Methods

• Research Question: In adult ICU patients ventilated for <4 days and predicted to need ≥7 additional days of ventilatory support, does early tracheostomy (≤4 days of ICU admission) reduce mortality compared with deferred tracheostomy (≥10 days and only if still indicated)?
• Study Type: Pragmatic, open, multicentre, randomised clinical trial; 70 adult general and 2 cardiothoracic critical care units in the UK (13 university and 59 non-university hospitals); recruitment 2004–2011 follow-up completed.
• Population:
  • Setting: adult critical care units (general + cardiothoracic) in the UK.
  • Inclusion: invasively mechanically ventilated; identified within the first 4 ICU days as likely to require ≥7 further days of ventilatory support.
  • Exclusion: immediate life-saving tracheostomy required; tracheostomy contraindicated (anatomical/other); respiratory failure due to chronic neurological disease (where early tracheostomy was usual practice in participating centres).
• Intervention:
  • Early tracheostomy placed within 4 days of ICU admission.
  • Technique (percutaneous or surgical), location, and operator seniority followed local unit practice.
• Comparison:
  • Deferred strategy: tracheostomy on day 10 or later, and only if still clinically indicated by the treating clinician.
  • Until then, usual care with translaryngeal intubation and clinician-directed co-interventions (sedation/weaning/antibiotics).
• Blinding: Unblinded (care teams and analysts could not be blinded because timing/airway status is apparent); primary endpoint (mortality) is objective.
• Statistics: Planned N=1692 to detect a 6.3% absolute (21% relative) mortality reduction with 80% power at 5% significance (two-sided), based on updated effect-size estimates; primary analyses were intention-to-treat; interim monitoring used a Peto–Haybittle stopping rule with four interim analyses (final significance threshold P=0.049); no futility boundary specified.
• Follow-Up Period: Primary endpoint at 30 days after randomisation; mortality follow-up to 2 years.

Key Results

This trial was stopped early. Recruitment ended before the revised target sample size (1692) after 909 patients were randomised due to study fatigue and exhaustion of funding; the monitoring committee did not specify a futility boundary.

• There was no mortality benefit at 30 days (30.8% vs 31.5%; RR 0.98; 95% CI 0.81 to 1.19; P=0.89) or at hospital discharge, 1 year, or 2 years.
• The deferred strategy avoided tracheostomy in a large proportion of patients (tracheostomy performed in 44.9% of the deferred group vs 91.9% of the early group), underscoring the uncertainty in predicting prolonged ventilation.
• Early tracheostomy reduced sedative exposure in survivors (median 5 vs 8 days; P<0.001) but did not significantly reduce days of respiratory support (mean 13.6 vs 15.2 days; mean difference −1.7; 95% CI −3.4 to 0.1; P=0.06) or ICU length of stay.

Internal Validity

• Randomisation and allocation: 24-hour automated telephone randomisation used minimisation (80% probability to the group that minimised imbalance) across centre, age, sex, and seven diagnostic groups; baseline characteristics were closely balanced (mean age 63.9 years; men 58.6%; mean APACHE II 19.8).
• Dropout/exclusions after randomisation: 899/909 (98.9%) were included in the primary analysis after exclusions for duplicate randomisation/randomisation error and withdrawals.
• Performance/detection bias: Unblinded design could influence co-interventions and process measures (sedation, extubation decisions); primary outcome (mortality) is objective.
• Protocol adherence and crossover: 385/455 (84.6%) received tracheostomy within 4 days as randomised; 66/455 did not (reasons included instability and recovery). In the deferred group, 33/454 received tracheostomy before day 10 (protocol deviation), and only 204/454 (44.9%) received a tracheostomy at any time.
• Separation of the variable of interest: Mean total days of respiratory support were 13.6 vs 15.2 (mean difference −1.7 days; 95% CI −3.4 to 0.1; P=0.06); among 30-day survivors, median days of any IV sedation were 5 vs 8 (P<0.001).
• Outcome assessment: Mortality follow-up extended to 2 years; cause of death not recorded; process outcomes were based on daily data capture and are potentially susceptible to unblinded management.
• Statistical rigour: Intention-to-treat analyses with prespecified plan; interim monitoring used a Peto–Haybittle rule (final P threshold 0.049); recruitment stopped early due to funding/study fatigue, increasing risk of missing modest treatment effects.

Conclusion on Internal Validity: Overall internal validity is moderate: randomisation and follow-up for mortality were strong, but unblinded care plus substantial dilution (many deferred-group patients never needing tracheostomy and protocol deviations in both directions) limits sensitivity to detect anything other than larger effects.

External Validity

• Population representativeness: Pragmatic enrolment across 72 UK ICUs (university and non-university) with predominantly medical admissions (79.2%) and pulmonary pathology common (69.3%); severity typical of general ICU ventilation cohorts (mean APACHE II 19.8).
• Applicability: The “predicted prolonged ventilation” inclusion criterion mirrors real-world decision-making, making results relevant to everyday ICU practice where timing choices are made under uncertainty.
• Important exclusions: Patients with chronic neurological disease causing respiratory failure were excluded (a group often managed with early tracheostomy), limiting generalisability to that subgroup.
• Health-system considerations: UK ICU bed constraints and practice patterns may differ from systems with different ventilation thresholds, step-down capacity, and reimbursement incentives.

Conclusion on External Validity: Generalisability is good for general adult ICU patients with early invasive ventilation in high-income settings, but extrapolation is more limited for specialised neuro/trauma cohorts and for health systems where tracheostomy thresholds and downstream resources differ materially.

Strengths & Limitations

• Strengths:
  • Large, pragmatic, multicentre randomised evaluation of a common ICU procedure.
  • Objective primary endpoint (30-day all-cause mortality) with longer-term mortality follow-up to 2 years.
  • Centralised randomisation with minimisation to balance key prognostic factors across diverse centres.
  • Clinically realistic comparator (watchful waiting with selective tracheostomy after day 10 if still indicated).
• Limitations:
  • Stopped before the revised target sample size (1692), reducing power for modest but clinically important effects.
  • Unblinded design with plausible influence on co-interventions and process outcomes.
  • Dilution of treatment contrast: only 44.9% of the deferred group ultimately received tracheostomy; protocol deviations occurred in both groups.
  • Technique and peri-procedural practices were not standardised (percutaneous vs surgical), which increases pragmatic relevance but introduces heterogeneity in delivery.
  • Nosocomial infection was not adjudicated as ventilator-associated pneumonia; antibiotic-free days were used as a proxy, which may not capture infection epidemiology precisely.

Interpretation & Why It Matters

• Practice implication

  Routine early tracheostomy (≤4 days) for patients predicted to need prolonged ventilation did not improve survival and did not shorten ICU stay compared with a deferred, selective strategy; this supports waiting until at least day 10 unless a patient-specific indication exists (e.g., airway protection, secretion management, or anticipated prolonged ventilation with high confidence).
• Mechanistic signal

  Early tracheostomy reduced sedative exposure (in survivors: median 5 vs 8 days), consistent with improved tolerance of ventilation/weaning, but this did not translate into fewer days of respiratory support or improved patient-centred outcomes.
• Systems insight

  A “watchful waiting” approach avoided tracheostomy in more than half of patients assigned to deferred care, highlighting prediction error as a core challenge in timing trials and in day-to-day ICU decision-making.

Controversies & Subsequent Evidence

• Predicting “prolonged ventilation” remains the pivotal limitation: TracMan demonstrated that many patients expected to require prolonged ventilation can recover (or die) before a delayed tracheostomy threshold, creating dilution when comparing a routine early approach against a selective deferred strategy.
• Early stopping and effect-size interpretation: Although recruitment stopped early, the observed relative risks for mortality outcomes clustered near 1.0 with confidence intervals that do not support a large mortality benefit from routine early placement.
• Financial and policy implications: The accompanying editorial emphasised that evidence favouring a “wait-and-see” strategy could conflict with reimbursement structures in some health systems, potentially creating misaligned incentives for early tracheostomy.¹
• Meta-analytic synthesis after TracMan: Subsequent systematic reviews and meta-analyses report that earlier tracheostomy may reduce pneumonia and ventilator days in some settings, but without consistent mortality benefit—reinforcing TracMan’s central message that routine early timing is not a survival intervention.²³
• Selected populations and endpoints: Later randomised evidence in severe stroke evaluated early vs standard tracheostomy with longer-horizon functional outcomes, illustrating that the “best” timing question can be population- and outcome-dependent rather than ICU-generic.⁴
• Quality and safety emphasis: Beyond timing, post-TracMan work has increasingly focused on standardisation and safety of tracheostomy care delivery, including multi-hospital quality improvement programmes.⁵

Summary

• Pragmatic UK multicentre RCT comparing routine early tracheostomy (≤4 ICU days) with deferred tracheostomy (≥10 days only if still indicated) in adults predicted to require prolonged ventilation.
• No difference in 30-day mortality: 30.8% (early) vs 31.5% (deferred); RR 0.98; 95% CI 0.81 to 1.19; P=0.89.
• No differences in ICU discharge, hospital discharge, 1-year, or 2-year mortality.
• Early tracheostomy reduced sedative exposure in 30-day survivors (median 5 vs 8 days; P<0.001) but did not shorten ICU stay or days of respiratory support.
• Deferred strategy avoided tracheostomy in most patients (tracheostomy performed in 44.9% vs 91.9%), highlighting prediction uncertainty and potential for unnecessary procedures with routine early placement.

Further Reading

Other Trials

• 2022Bösel J, Niesen WD, Salih F, et al. Effect of early vs standard tracheostomy on functional outcome at 6 months in patients with severe stroke: the SETPOINT2 randomized clinical trial. JAMA. 2022.
• 2012Koch T, Hecker B, Hecker A, et al. Early tracheostomy decreases ventilation time but has no impact on mortality of intensive care patients: a randomized study. Langenbecks Arch Surg. 2012;397(6):1001-1008.
• 2010Terragni PP, Antonelli M, Fumagalli R, et al. Early vs late tracheotomy for prevention of pneumonia in mechanically ventilated adult ICU patients: a randomized controlled trial. JAMA. 2010;303(15):1483-1489.
• 2008Blot F, Similowski T, Trouillet JL, et al. Early tracheotomy versus prolonged endotracheal intubation in unselected severely ill ICU patients. Intensive Care Med. 2008;34(10):1779-1787.
• 2004Rumbak MJ, Newton M, Truncale T, Schwartz SW, Adams JW, Hazard PB. A prospective, randomized, study comparing early percutaneous dilational tracheotomy to prolonged translaryngeal intubation (delayed tracheotomy) in critically ill medical patients. Crit Care Med. 2004;32(8):1689-1694.

Systematic Review & Meta Analysis

• 2021Chorath K, Hoang A, Rajasekaran K, Moreira A. Association of early vs late tracheostomy placement with pneumonia and ventilator days in critically ill patients: a meta-analysis. JAMA Otolaryngol Head Neck Surg. 2021;147(5):450-459.
• 2016Meng L, Wang C, Li J, Zhang J. Early vs late tracheostomy in critically ill patients: a systematic review and meta-analysis. Clin Respir J. 2016;10(6):684-692.
• 2015Szakmany T, Russell P, Wilkes AR, Hall JE. Effect of early tracheostomy on resource use and clinical outcomes in critically ill patients: meta-analysis of randomised controlled trials. Br J Anaesth. 2015;114(3):396-405.
• 2015Liu CC, Livingstone D, Dixon E, Dort JC. Early versus late tracheostomy: a systematic review and meta-analysis. Otolaryngol Head Neck Surg. 2015;152(2):219-227.
• 2015Andriolo BN, Andriolo RB, Saconato H, Atallah AN, Valente O. Early versus late tracheostomy for critically ill patients. Cochrane Database Syst Rev. 2015;(1):CD007271.

Observational Studies

• 2010Wunsch H, Linde-Zwirble WT, Angus DC, Hartman ME, Milbrandt EB, Kahn JM. The epidemiology of mechanical ventilation use in the United States. Crit Care Med. 2010;38(10):1947-1953.
• 2008Scales DC, Thiruchelvam D, Kiss A, Redelmeier DA. The effect of tracheostomy timing during critical illness on long-term survival. Crit Care Med. 2008;36(9):2547-2557.
• 2007Clec’h C, Alberti C, Vincent F, et al. Tracheostomy does not improve the outcome of patients requiring prolonged mechanical ventilation: a propensity analysis. Crit Care Med. 2007;35(1):132-138.
• 2007Combes A, Luyt CE, Nieszkowska A, Trouillet JL, Gibert C, Chastre J. Is tracheostomy associated with better outcomes for patients requiring long-term mechanical ventilation? Crit Care Med. 2007;35(3):802-807.
• 2004Cox CE, Carson SS, Holmes GM, Howard A, Carey TS. Increase in tracheostomy for prolonged mechanical ventilation in North Carolina, 1993-2002. Crit Care Med. 2004;32(11):2219-2226.

Guidelines

• 2020McGrath BA, Wallace S, Lynch J, et al. Improving tracheostomy care in the United Kingdom: results of a guided quality improvement programme in 20 diverse hospitals. Br J Anaesth. 2020;125(1):e119-e129.
• 2018Devlin JW, Skrobik Y, Gélinas C, et al. Clinical practice guidelines for the prevention and management of pain, agitation/sedation, delirium, immobility, and sleep disruption in adult patients in the ICU. Crit Care Med. 2018;46(9):e825-e873.
• 2013Mitchell RB, Hussey HM, Setzen G, et al. Clinical consensus statement: tracheostomy care. Otolaryngol Head Neck Surg. 2013;148(1):6-20.
• 2001MacIntyre NR, Cook DJ, Ely EW Jr, et al. Evidence-based guidelines for weaning and discontinuing ventilatory support. Chest. 2001;120(6 Suppl):375S-395S.

Notes

• Where a DOI landing page could not be confirmed from the available source set, a PubMed search landing page is used to ensure traceability without guessing identifiers.
• The deferred arm in TracMan represents a pragmatic “watchful waiting with selective tracheostomy” strategy rather than “late tracheostomy for everyone”, which is central when comparing across studies and meta-analyses.

Overall Takeaway

TracMan established that routinely performing tracheostomy within the first 4 ICU days in patients predicted to need prolonged ventilation does not improve survival compared with waiting until day 10 and proceeding only if still indicated. The trial’s most durable contribution is methodological and practical: prediction uncertainty is large, so a deferred, selective strategy can avoid many procedures while preserving patient-centred outcomes, with any benefits of earlier timing largely confined to reduced sedative exposure rather than survival.

Bibliography

• 1.Angus DC. When should a mechanically ventilated patient undergo tracheostomy? JAMA. 2013;309(20):2163-2164. Link
• 2.Chorath K, Hoang A, Rajasekaran K, Moreira A. Association of early vs late tracheostomy placement with pneumonia and ventilator days in critically ill patients: a meta-analysis. JAMA Otolaryngol Head Neck Surg. 2021;147(5):450-459. Link
• 3.Andriolo BN, Andriolo RB, Saconato H, Atallah AN, Valente O. Early versus late tracheostomy for critically ill patients. Cochrane Database Syst Rev. 2015;(1):CD007271. Link
• 4.Bösel J, Niesen WD, Salih F, et al. Effect of early vs standard tracheostomy on functional outcome at 6 months in patients with severe stroke: the SETPOINT2 randomized clinical trial. JAMA. 2022. Link
• 5.McGrath BA, Wallace S, Lynch J, et al. Improving tracheostomy care in the United Kingdom: results of a guided quality improvement programme in 20 diverse hospitals. Br J Anaesth. 2020;125(1):e119-e129. Link