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Trial registered on ANZCTR

Registration number

ACTRN12611000342910

Ethics application status

Approved

Date submitted

31/03/2011

Date registered

1/04/2011

Date last updated

1/04/2011

Type of registration

Retrospectively registered

Titles & IDs

Public title

Percutaneous Dilatational Versus Conventional Surgical Tracheostomy in Intensive Care Patients.

Scientific title

A prospective randomized trial of percutaneous dilatational versus conventional surgical tracheostomy in intensive care patients regarding the operative time, the mean size of tracheostomy tube, intra-operative bleeding and postoperative infection .

Secondary ID [1]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Tracheostomy for airway protection

Condition category

Condition code

Respiratory

Other respiratory disorders / diseases

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

All patients were subjected to general anesthesia and orotracheal intubation with continuous monitoring arterial blood gasses , blood pressure, electrocardiography , pulse oximetry , intra operative blood loss and record to tracheostomy tube size. Percutaneous dilatational tracheostomy (PDT) was done using the Griggs’ guide wire dilating forceps technique (through trans cervical insertion and the trachea cannulated with 14-G cannula between the second, or the second and third tracheal rings and J guide wire inserted followed by blunt dilation.This procedure was successful n the PDT group and was performed as a single intervention for each patient with a mean operative time of 20 minutes.

Intervention code [1]

Treatment: Devices

Intervention code [2]

Treatment: Surgery

Comparator / control treatment

Conventional surgical tracheostomy (CST) patients group subjected to horizontal skin incision midway between the sternal notch and cricoid cartilage, , revealing the thyroid isthmus and then the cricoid cartilage identified , cricoid hook used to pull the trachea superiorly finally insert suitable tracheostomy tube. This procedure was successful in all patients and was performed as a single intervention for each patient with a mean operative time of 19.3 minutes

Control group

Active

Outcomes

Primary outcome [1]

Mortality rate.
Mortality related to both tracheostomy techniques was only considered during the first postoperative week.

Timepoint [1]

1 week

Secondary outcome [1]

Operative time

Timepoint [1]

Intraoperative

Secondary outcome [2]

Mean size of tracheostomy tube

Timepoint [2]

Intraoperative

Secondary outcome [3]

intra-operative bleeding

Timepoint [3]

Intraoperative

Secondary outcome [4]

Postoperative infection was assessed by clinical examination of wounds

Timepoint [4]

7 days

Eligibility

Key inclusion criteria

critically ill patients admitted to intensive care unite for prolonged intubation, airway protection or pulmonary hygiene .

Minimum age

32 Years

Maximum age

67 Years

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Patients with distorted anatomy, history of previous surgery at the neck , bleeding disorder, goiter , neck masses , unstable general condition or cervical spine trauma were excluded.

Study design

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

Phase

Not Applicable

Type of endpoint/s

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

16/02/2007

Actual

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

Accrual to date

Final

Recruitment outside Australia

Country [1]

Egypt

State/province [1]

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Suez Canal University hospital

Address [1]

Faculty of medicine, Suez Canal University, Egypt

Country [1]

Egypt

Primary sponsor type

Individual

Name

Tarek .F. Youssef

Address

Faculty of medicine, Suez Canal University, Egypt

Country

Egypt

Secondary sponsor category [1]

Individual

Name [1]

Aly Saber

Address [1]

Port-Fouad general Hospital, Port-Fouad, Egypt.

Country [1]

Egypt

Secondary sponsor category [2]

None

Name [2]

Address [2]

Country [2]

Ethics approval

Ethics application status

Approved

Summary

Brief summary

Tracheostomy is  usually performed in patients with difficult weaning from mechanical ventilation or some catastrophic neurologic insult.  Percutaneous dilatational tracheostomy (PDT) is increasingly popular and has gained widespread acceptance in many ICU and trauma centers as a viable alternative approach.
64 critically ill patients admitted to intensive care unite subjected to tracheostomy  and randomly divided into two groups; percutaneous dilatational tracheostomy (PDT) and conventional surgical tracheostomy (CST).Operations were performed by the surgical team in the university hospital, department of Otolaryngology, Faculty of medicine, Suez Canal University, Egypt from 1/2/2007 to 31/8/2010.
  The aim was  to compare the outcome of both  techniques regarding mortality rate, intraoperative bleeding,the tracheostomy tube size and wound infection.
Conclusion:    PDT technique is similar effective and safe as CST with low incidence of post operative complication.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Address

Country

Phone

Fax

Contact person for public queries

Name

Aly Saber

Address

Port-Fouad general Hospital, Port-Fouad, Egypt.

Country

Egypt

Phone

+2/066/ 3406474

Fax

[email protected]

Contact person for scientific queries

Name

Aly Saber

Address

Port-Fouad general Hospital, Port-Fouad, Egypt.

Country

Egypt

Phone

+2/066/3406474

Fax

[email protected]

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Dimensions AI	Percutaneous dilatational versus conventional surgical tracheostomy in intensive care patients	2011	https://doi.org/10.4297/najms.2011.3508

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically