NCT03059654

Brief Summary

To evaluate the usefulness of ultrasound-guided percutaneous dilatation tracheostomy PCT in obese patients.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2015

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

February 13, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 23, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

February 23, 2017

Status Verified

February 1, 2017

Enrollment Period

1.8 years

First QC Date

February 13, 2017

Last Update Submit

February 20, 2017

Conditions

Tracheostomy Techniques

Keywords

Percutaneous tracheostomysurgical tracheostomyairway ultrasoundintensive care

Outcome Measures

Primary Outcomes (1)

  • Duration of the procedure in both groups in minutes

    From start of procedure till skin closure

    average forty five minutes.

Secondary Outcomes (1)

  • incidence of complications in both groups

    four weeks

Study Arms (2)

Ultrasound PCT

ACTIVE COMPARATOR

Ultrasound guide Percutaneous tracheostomy

Procedure: tracheostomy

Surgical tracheostomy

ACTIVE COMPARATOR

Surgical tracheostomy

Procedure: tracheostomy

Interventions

tracheostomyPROCEDURE
Surgical tracheostomyUltrasound PCT

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Critically ill patients aged over 18 years old needing tracheostomy.
  • Both genders.
  • Obese patients with neck circumference ≥ 40 cm.

You may not qualify if:

  • Patients with coagulopathy (partial thromboplastin time \> 50 seconds and international normalization ratio \> 1.5 or platelets count \< 80000 / mm3).
  • History of difficult laryngoscopy (Cormack-Lehane Grade 2b view) documented on intubation.
  • Requirement of high Positive End Expiratory Pressure (PEEP \> 10 cmH2O) or high fraction inspired oxygen (FiO2 \> 0.8).
  • Infection at the site of tracheostomy.
  • Previous neck surgery or radiotherapy.
  • Hypersensitivity to local anesthetics.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Suez Canal University Hospital

Ismailia, Ismailia Governorate, 41522, Egypt

RECRUITING

Suez Canal University hospital

Ismailia, Ismailia Governorate, 41522, Egypt

RECRUITING

MeSH Terms

Interventions

Tracheostomy

Intervention Hierarchy (Ancestors)

Airway ManagementTherapeuticsOstomySurgical Procedures, OperativeOtorhinolaryngologic Surgical ProceduresThoracic Surgical Procedures

Central Study Contacts

Mohamed E. Abdel-Ghaffar, MD

CONTACT

+201003179831mohamed_abdelghafa@med.suez.edu.eg

Mohamed A Elsadany, MD

CONTACT

+201097973797sadany20@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
DEVICE FEASIBILITY
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor and chairman, department of Anesthesia and Intensive Care, Faculty of Medicine.

Study Record Dates

First Submitted

February 13, 2017

First Posted

February 23, 2017

Study Start

September 1, 2015

Primary Completion

June 1, 2017

Study Completion

August 1, 2017

Last Updated

February 23, 2017

Record last verified: 2017-02

Locations

EG(2)