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

ISRCTN	ISRCTN01157856
DOI	https://doi.org/10.1186/ISRCTN01157856
Secondary identifying numbers	N/A

Submission date: 23/01/2010
Registration date: 19/02/2010
Last edited: 19/02/2010

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Surgery

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Markus Weigand
Scientific

Rudolf-Buchheim-Street 7
Giessen
35392
Germany

Email	Markus.Weigand@chiru.med.uni-giessen.de

Study information

Study design	Single centre cross-departmental prospective randomised active controlled clinical trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use contact details below to request a patient information sheet.
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.
Study objectives	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(s)	Ethics approval was received by the Ethics board of the University Hospital of Giessen, Germany in January 2005.
Health condition(s) or problem(s) studied	Intensive Care Units (ICUs); Percutaneous Dilatational Tracheostomy (PTD); ventilatory support
Intervention	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.
Intervention type	Procedure/Surgery
Primary outcome measure	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 measures	None
Overall study start date	02/01/2005
Completion date	02/01/2007

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	100
Key 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
Key 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
Date of first enrolment	02/01/2005
Date of final enrolment	02/01/2007

Locations

Countries of recruitment

Germany

Study participating centre

Rudolf-Buchheim-Street 7

Giessen
35392
Germany

Sponsor information

University Hospital of Giessen (Germany)
Hospital/treatment centre

Department of Anaesthesiology and Intensive Care Medicine
Rudolf-Buchheim-Street 7
Giessen
35392
Germany

Email	Andreas.Hecker@chiru.med.uni-giessen.de
"ROR"	https://ror.org/032nzv584

Funders

Funder type

Hospital/treatment centre

University Hospital of Giessen (Germany) - Department of Anaesthesiology and Intensive Care Medicine

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan