Ultrasound Guided Percutaneous Tracheostomy
This study has been completed.
Sponsor:
Centre Hospitalier Universitaire, Amiens
Information provided by (Responsible Party):
Pierre-Grégoire Guinot, Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov Identifier:
NCT01502657
First received: April 21, 2011
Last updated: December 30, 2011
Last verified: December 2011
| Tracking Information | |||||
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| First Received Date ICMJE | April 21, 2011 | ||||
| Last Updated Date | December 30, 2011 | ||||
| Start Date ICMJE | September 2010 | ||||
| Primary Completion Date | November 2011 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Procedure related complications [ Time Frame: At the end of the procedure, then participants will be followed for the duration of hospital stay, an expected average of 6 weeks ] [ Designated as safety issue: Yes ] Complications are: paratracheal insertion, injuries to blood vessels in the neck, oesophageal injury, accidental decannulation, malposition of the tracheostomy tube, tracheal cuff puncture, multiple punctures (more than 3), surgical conversion and percutaneous tracheostomy failure, bleeding (compressible, incompressible, requiring administration of labile blood products), pneumothorax, pneumomediastinum, tracheostomy puncture site infection, surgical conversion, subglottic stenosis, fracture of a tracheal cartilage, granuloma. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01502657 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Procedure time [ Time Frame: The time will be calculated at the end of the procedure; an average of 30 minutes ] [ Designated as safety issue: No ] The total time consisted of a first phase of ulstrasound examination of the cervical region and an implementation phase under ultrasound of percutaneous tracheostomy. |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Ultrasound Guided Percutaneous Tracheostomy | ||||
| Official Title ICMJE | Ultrasound Guided Percutaneous Tracheostomy in the ICU | ||||
| Brief Summary | The purpose of this study is to determine the feasibility and the safety of ultrasound guided percutaneous dilatational tracheostomy. |
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| Detailed Description | Percutaneous tracheostomy is commonly performed in critical care units when ventilatory weaning fails or when prolonged mechanical ventilation is required. Numerous complications have been described since the widespread use of Percutaneous Tracheostomy (PCT). Bronchoscopy-guided percutaneous tracheostomy was developed in this context. However, bronchoscopy cannot identify vascular structures and the thyroid gland in the neck, and therefore cannot prevent complications related to organ lesions in the neck. Several studies have demonstrated the value of ultrasound guidance in the neck before performing PCT. No studies have demonstrated the feasibility and the safety of ultrasound guidance for PCT. Ultrasound could improve the understanding of neck anatomy, prevents vascular puncture, and helps guide insertion of the tracheostomy tube. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Supportive Care |
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| Condition ICMJE |
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| Intervention ICMJE | Device: Ultrasonography (EnVisor Philips Medical Systems)
Percutaneous tracheostomy is performed using the dilatational method with ultrasonography guidance;
Other Names:
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| Study Arm (s) | Not Provided | ||||
| Publications * | Guinot PG, Zogheib E, Petiot S, Marienne JP, Guerin AM, Monet P, Zaatar R, Dupont H. Ultrasound-guided percutaneous tracheostomy in critically ill obese patients. Crit Care. 2012 Dec 12;16(2):R40. doi: 10.1186/cc11233. | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 40 | ||||
| Completion Date | December 2011 | ||||
| Primary Completion Date | November 2011 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | France | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01502657 | ||||
| Other Study ID Numbers ICMJE | PI10-DR-GUINOT, 2010-A00901-38 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Pierre-Grégoire Guinot, Centre Hospitalier Universitaire, Amiens | ||||
| Study Sponsor ICMJE | Centre Hospitalier Universitaire, Amiens | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Centre Hospitalier Universitaire, Amiens | ||||
| Verification Date | December 2011 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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