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

Completed

• Conditions: Intensive Care Units (ICUs); Percutaneous Dilatational Tracheostomy (PTD); Surgery; ventilatory support

• Registration Number: ISRCTN01157856
• Lead Sponsor: niversity Hospital of Giessen (Germany)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-02-19
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 100

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

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 < 60,000 per µl, prothrombin time > 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

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