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| [ Print-friendly version ] |
| A comparison of early versus late tracheostomy after intubation for critically ill patients on long-term ventilation. |
| ISRCTN | ISRCTN01157856 |
| ClinicalTrials.gov identifier | |
| Public title | A comparison of early versus late tracheostomy after intubation for critically ill patients on long-term ventilation. |
| Scientific title | 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. |
| Acronym | N/A |
| Serial number at source | N/A |
| Study hypothesis |
Long-term ventilation in intensive care units is associated with several problems such as increased mortality, increased rates of ventilator associated pneumonia (VAP), prolonged time of hospitalisation, and thus, leads to enormous financial consequences. While the influence of tracheostomy on VAP incidence, duration of ventilation, and time of hospitalisation has already been analyzed in several studies, the point of timing of the tracheostomy procedure on patient's mortality is still controversial. Within 2 years, 100 critically ill, mainly surgical patients entered this prospective randomized study. A percutaneous dilatational tracheostomy (PDT) was performed either early (4 days after intubation, 2.8 days median) or late (more than 6 days after intubation, 8.1 days median) after intubation. We compared both groups concerning outcome, VAP incidence and duration of hospitalisation and ventilation. This was a cross-departmental trial with collaboration between the Dept. of Anaethesiology, Dept. of Surgery Dept. of Neurosurgery and Dept. of Neurology.
Hypotheses: 1. Early tracheostomy is associated with a decreased mortality in critically ill surgical patients. 2. Early PDT performance, in comparison with late tracheostomy, is associated with decreased rates of VAP, duration of ventilation and time of hospitalization both in hospital and in (Intensive Care Units (ICUs). |
| Ethics approval | Ethics approval was received by the Ethics board of the University Hospital of Giessen, Germany in January 2005. |
| Study design | Single centre cross-departmental prospective randomised active controlled clinical trial |
| Countries of recruitment | Germany |
| Disease/condition/study domain | Intensive Care Units (ICUs); Percutaneous Dilatational Tracheostomy (PTD); ventilatory support |
| Participants - 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 |
| Participants - 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 |
| Anticipated start date | 02/01/2005 |
| Anticipated end date | 02/01/2007 |
| Status of trial | Completed |
| Patient information material | Not available in web format, please use contact details below to request a patient information sheet. |
| Target number of participants | 100 |
| 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 intubation/trauma/surgery in LT patients the same procedure was performed after more than 6 days of intubation. The Acute Physiology And Chronic Health Evaluation II (APACHE II) score was used to define the severity of the trauma. In each group 25 patients with APACHE II < 25 and > 25 were recruited. Patients were followed until discharged from the hospital or rehabilitation centre. |
| Primary outcome measure(s) |
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. |
| Secondary outcome measure(s) | None |
| Sources of funding | University Hospital of Giessen (Germany) - Department of Anaesthesiology and Intensive Care Medicine |
| Trial website | |
| Publications | |
| Contact name | Prof Markus Weigand |
| Address | Rudolf-Buchheim-Street 7 |
| City/town | Giessen |
| Zip/Postcode | 35392 |
| Country | Germany |
| Markus.Weigand@chiru.med.uni-giessen.de | |
| Sponsor | University Hospital of Giessen (Germany) |
| Address |
Department of Anaesthesiology and Intensive Care Medicine
Rudolf-Buchheim-Street 7 |
| City/town | Giessen |
| Zip/Postcode | 35392 |
| Country | Germany |
| Andreas.Hecker@chiru.med.uni-giessen.de | |
| Date applied | 23/01/2010 |
| Last edited | 19/02/2010 |
| Date ISRCTN assigned | 19/02/2010 |
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| © 2010 ISRCTN unless otherwise stated. | |
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