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Are there differences in the clinical course of critically ill patients undergoing prolonged mechanical ventilation when performing tracheostomy early or late?

Impact of early or late tracheostomy in the clinical course of critically ill patients undergoing prolonged mechanical ventilation: a randomized clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN22208087
Enrollment
1452
Registered
2014-03-27
Start date
2006-01-01
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Critically ill patients with respiratory failure of different etiologies and prolonged mechanical ventilation requirements Respiratory

Interventions

The tracheotomy was performed in accepted patients according to the result of randomization: early (before day 8) or late (from day 14 onwards of MV). In the remaining patients the decision of whether

Sponsors

University Hospital of Bellvitge (Hospital Universitari de Bellvitge) (Spain)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients admitted to the intensive care unit (ICU) with: 1. Aged over 17 2. Over 2 days of mechanical ventilation and expected by attending physician to be 7 or more days of mechanical ventilation

Exclusion criteria

Exclusion criteria: 1. Patients already tracheotomized 2. Patients previously included in another trial 3. Technical difficulty to perform a percutaneous tracheotomy 4. Patients without limitation of life support but any of the following conditions: intracranial hypertension (ICP> 15), risk of bleeding (platelets 1.5), severe respiratory failure (PEEP> 10cmH20 or PO2 / FiO2 <100) 5. Patients with poor prognosis and any type of decision to limit life support measures 6. Patients requiring urgent tracheotomy on medical grounds (to improve the management of the upper airway, neurological illness, etc.)

Design outcomes

Primary

MeasureTime frame
Mortality at 90 days of ICU admission

Secondary

MeasureTime frame
1. Number of days free of mechanical ventilation at 28 and 90 days 2. ICU length of stay 3. Number of days with continuous perfusion of sedatives 4. Incidence of pneumonia These outcomes are measured using patient records.

Countries

Spain

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 7, 2026