VivaSight-SL™ Versus Bronchoscopy for Percutaneous Tracheotomy

NCT02861001 | Completed

• 1 other identifier: VivaPDT
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

Optical guidance for percutaneous tracheotomy in intensive care is usually performed by bronchoscopy. Recently, an endotracheal tube with a camera mounted at its tip (VivaSight-SL) has been introduced that allows for endotracheal visualization. For feasibility evaluation, ten patients in intensive care receive percutaneous tracheotomy with optical guidance by the VivaSight-SL tube. If this part is completed with satisfactory results, patients are randomized to receive optical guidance by bronchoscopy or by VivaSight-SL tube. The primary end point is the visualization through the tube camera of endotracheal landmark structures for tracheotomy and visualization of the needle insertion (according to score, see detailed description).

Conditions

Respiratory Insufficiency

Keywords

tracheotomy; bronchoscopy; critical care

Outcome Measures

Primary Outcomes (1)

• visualization through the tube camera of endotracheal landmark structures for tracheotomy and visualization of the needle insertion (according to score)

  during tracheotomy

Secondary Outcomes (9)

• minute ventilation according to score generated from 4 point Likert scale at 2 time points

  two time points: 1. during identification of landmark structures before puncture of trachea, 2. during puncture, dilatation and tracheotomy

• pulse oxymetric oxygen saturation according to score generated from 4 point Likert scale at 2 time points

  two time points: 1. during identification of landmark structures before puncture of trachea, 2. during puncture, dilatation and tracheotomy

• change in pH-values

  three time points: baseline value (up to 1h before tracheotomy), 0 min before skin incision, and 0 min before insertion of tracheal cannula

• change in paCO2 values

  three time points: baseline value (up to 1h before tracheotomy), 0 min before skin incision, and 0 min before insertion of tracheal cannula

• change in etCO2 values

  three time points: baseline value (up to 1h before tracheotomy), 0 min before skin incision, and 0 min before insertion of tracheal cannula

Study Arms (2)

bronchoscopic guidance

ACTIVE COMPARATOR

optical guidance of percutaneous tracheotomy is done by conventional bronchoscopy

Device: conventional bronchoscopy

tube mounted camera guidance

EXPERIMENTAL

optical guidance of percutaneous tracheotomy is done by the VivaSight-SL tube

Device: VivaSight-SL tube

Interventions

conventional bronchoscopy DEVICE

optical guidance of percutaneous tracheotomy is done by conventional bronchoscopy

bronchoscopic guidance

VivaSight-SL tube DEVICE

optical guidance of percutaneous tracheotomy is done by the VivaSight-SL tube

tube mounted camera guidance

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients receiving percutaneous tracheotomy in the Dept. of Intensive Care Medicine.
• Age ≥ 18 years
• Informed consent

You may not qualify if:

• Age \< 18 years
• No consent
• Direct laryngoscopy according to Cormack-Lehane ≥ 3

Sponsors & Collaborators

• Universitätsklinikum Hamburg-Eppendorf: lead

Study Sites (1)

Universitätsklinikum Hamburg-Eppendorf

Hamburg, Hamburg, 20246, Germany

Location

Related Publications (9)

• Dreher M, Kluge S. [Airway devices in the intensive care unit]. Pneumologie. 2014 Jun;68(6):371-7. doi: 10.1055/s-0034-1365318. Epub 2014 Mar 25. German.

  PMID: 24668495 BACKGROUND

• Ciaglia P, Firsching R, Syniec C. Elective percutaneous dilatational tracheostomy. A new simple bedside procedure; preliminary report. Chest. 1985 Jun;87(6):715-9. doi: 10.1378/chest.87.6.715.

  PMID: 3996056 BACKGROUND

• Braune S, Kluge S. [Percutaneous dilatational tracheostomy]. Dtsch Med Wochenschr. 2011 Jun;136(23):1265-9. doi: 10.1055/s-0031-1280549. Epub 2011 May 31. No abstract available. German.

  PMID: 21630175 BACKGROUND

• Vargas M, Sutherasan Y, Antonelli M, Brunetti I, Corcione A, Laffey JG, Putensen C, Servillo G, Pelosi P. Tracheostomy procedures in the intensive care unit: an international survey. Crit Care. 2015 Aug 13;19(1):291. doi: 10.1186/s13054-015-1013-7.

  PMID: 26271742 BACKGROUND

• Huitink JM, Koopman EM, Bouwman RA, Craenen A, Verwoert M, Krage R, Visser IE, Erwteman M, van Groeningen D, Tijink R, Schauer A. Tracheal intubation with a camera embedded in the tube tip (Vivasight() ). Anaesthesia. 2013 Jan;68(1):74-8. doi: 10.1111/anae.12065. Epub 2012 Nov 5.

  PMID: 23121322 BACKGROUND

• Linstedt U, Zenz M, Krull K, Hager D, Prengel AW. Laryngeal mask airway or endotracheal tube for percutaneous dilatational tracheostomy: a comparison of visibility of intratracheal structures. Anesth Analg. 2010 Apr 1;110(4):1076-82. doi: 10.1213/ANE.0b013e3181d27fb4.

  PMID: 20357150 BACKGROUND

• Baumann HJ, Kemei C, Kluge S. [Tracheostomy in the intensive care unit]. Pneumologie. 2010 Dec;64(12):769-76. doi: 10.1055/s-0030-1255743. Epub 2010 Sep 20. German.

  PMID: 20857374 BACKGROUND

• Byhahn C, Wilke HJ, Halbig S, Lischke V, Westphal K. Percutaneous tracheostomy: ciaglia blue rhino versus the basic ciaglia technique of percutaneous dilational tracheostomy. Anesth Analg. 2000 Oct;91(4):882-6. doi: 10.1097/00000539-200010000-00021.

  PMID: 11004042 BACKGROUND

• Grensemann J, Eichler L, Kahler S, Jarczak D, Simon M, Pinnschmidt HO, Kluge S. Bronchoscopy versus an endotracheal tube mounted camera for the peri-interventional visualization of percutaneous dilatational tracheostomy - a prospective, randomized trial (VivaPDT). Crit Care. 2017 Dec 29;21(1):330. doi: 10.1186/s13054-017-1901-0.

  PMID: 29284503 DERIVED

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Study Officials

• Stefan Kluge, MD, PhD

  Head of Dept. of Intensive Care Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2016
• First Posted: August 10, 2016
• Study Start: April 1, 2016
• Primary Completion: January 13, 2017
• Study Completion: January 13, 2017
• Last Updated: March 23, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)