A comparison of early versus late tracheostomy after intubation for critically ill patients on long-term ventilation.

A prospective randomised trial to compare the effects early versus late Percutaneous Dilatational Tracheostomy (PTD) after incubation on the rate of Ventilator-Associated Pneumonia (VAP), mortality and other factors in critically ill patients on long-term ventilation.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN01157856

Enrollment

100

Registered

2010-02-19

Start date

2005-01-02

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

Intensive Care Units (ICUs)

Interventions

After intubation patients either entered the early (ET) or the late tracheostomy (LT) trunk of this study: In ET patients a percutaneous dilatational tracheostomy was performed within 4 days after int

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Critically-ill patients requiring ventilatory support and intubation, recruited from the following three ICUs: surgical, neurological, neurosurgical. 2. Expected time of ventilation > 21 days 3. Age > 18 years 4. Informed consent that the patient may be included into the study

Exclusion criteria

Exclusion criteria: 1. Anatomic variants or deformities of the larynx, trachea, and collum 2. Pre-existing tracheostomy 3. Pre-existing pneumonia 4. Critical trauma of the cervical vertebral column 5. Coagulopathy (thrombocytes 40 seconds, international normalized ratio > 1.4) 6. Estimated to die within the next 24 h 7. Planned permanent tracheostomy (after laryngectomy) 8. More than 3 days of ventilation before entry into the study

Design outcomes

Primary

Measure	Time frame
1. VAP as defined by 1.1. Clinical Pulmonary Infection Score (CPIS) 1.2. Sequential Organ Failure Assessment (SOFA) score 2. APACHE II score 3. Simplified acute physiology score (SAPS) 4. Temperature 5. Laboratory values 5.1. C-Reactive Protein (CRP) 5.2. Leukocytes 6. Thoracic X-ray 7. Days in ICU/hospital 8. Hours of ventilatory support APACHE II score was measured at baseline, all other outcomes were measured daily.	—

Measure

Time frame

1. VAP as defined by 1.1. Clinical Pulmonary Infection Score (CPIS) 1.2. Sequential Organ Failure Assessment (SOFA) score 2. APACHE II score 3. Simplified acute physiology score (SAPS) 4. Temperature 5. Laboratory values 5.1. C-Reactive Protein (CRP) 5.2. Leukocytes 6. Thoracic X-ray 7. Days in ICU/hospital 8. Hours of ventilatory support APACHE II score was measured at baseline, all other outcomes were measured daily.

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Countries

Germany

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026