Video-guided Percutaneous Tracheostomy (PCT) Versus Conventional PCT: Comparing Safety and Efficacy

NCT01012518 | Unknown

• 1 other identifier: TASMC-09-PS-0544-CTIL
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare the feasibility, safety, efficacy and ease of performance of a video-assisted PCT (via an endotracheal tube embedded with a mini video-camera) with the standard ("blind") PCT technique.

Conditions

Bleeding; Hypoxia; Atelectasis; Pneumothorax; Pneumomediastinum

Keywords

percutaneous tracheostomy; paratracheal insertion; tracheal injury; transtracheal needle; ventilatory parameters

Outcome Measures

Primary Outcomes (1)

• procedure-related complications

  6h

Secondary Outcomes (1)

• operative time

  minutes

Study Arms (2)

Conventional PCT

ACTIVE COMPARATOR

PCT performed without video guidance, as conventionally performed

Device: Standard PCT

Video-assisted PCT

EXPERIMENTAL

PCT performed with the guidance of a camera-embedded ETT wired to a monitor

Device: Video-guided PCT

Interventions

Standard PCT DEVICE

The standard technique, performed without video guidance

Also known as: Control, Conventional PCT

Conventional PCT

Video-guided PCT DEVICE

PCT performed with the guidance of a camera-embedded ETT wired to a monitor

Also known as: Video-assisted PCT, ETView-guided PCT

Video-assisted PCT

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The investigators will enroll for this study
• patients aged \>18 years old, admitted to the ICU,
• who require elective PCT for prolonged mechanical ventilation, airway protection or weaning failure.

You may not qualify if:

• Patients indicated for surgical tracheostomy, due to altered or difficult local anatomy;
• necessity of emergency airway access due to acute airway compromise;
• evidence of infection in the soft tissues of the neck;
• coagulation abnormalities (INR\>1.5, PTT\>40, thrombocyte count \< 50,000);
• gross distortion of the neck anatomy (due to hematoma/tumor/thyromegaly/scarring from previous neck surgery/ unstable C-spine);
• contra-indication for re-intubation/suspected loss of airway during re-intubation; hemodynamic instability.

Sponsors & Collaborators

• Tel-Aviv Sourasky Medical Center: lead

Study Sites (1)

Tel-Aviv Sourasky Medical Center

Tel Aviv, 64239, Israel

Location

MeSH Terms

Conditions

Hemorrhage; Hypoxia; Pulmonary Atelectasis; Pneumothorax; Mediastinal Emphysema

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Respiratory; Signs and Symptoms; Lung Diseases; Respiratory Tract Diseases; Pleural Diseases; Mediastinal Diseases; Thoracic Diseases; Emphysema

Study Officials

• Patrick Sorkine, MD

  Tel-Aviv Sourasky Medical Center

  PRINCIPAL INVESTIGATOR

• Idit Matot, MD

  Tel-Aviv Sourasky Medical Center

  STUDY CHAIR

Central Study Contacts

Patrick Sorkine, MD

CONTACT

97236973390; patricks@tasmc.health.gov.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: November 11, 2009
• First Posted: November 13, 2009
• Study Start: January 1, 2010
• Primary Completion: December 1, 2010
• Study Completion: February 1, 2011
• Last Updated: November 13, 2009

Record last verified: 2009-11

Locations

IL (1)