ICTRP Search Portal

Main

Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ISRCTN
Last refreshed on:	11 February 2019
Main ID:	ISRCTN57679531
Date of registration:	12/02/2013
Prospective Registration:	Yes
Primary sponsor:	Ministry of Health (Oman)
Public title:	Evaluation of Truflex™ Flexible Stylet as an intubation guide with the D-blade of C-Mac videolaryngoScope during elective tracheal intubation
Scientific title:	Assessment of Truflex™ Flexible Stylet versus conventional rigid Portex™ stylet as an intubation guide with the D-blade of C-Mac videolaryngoScope during elective tracheal intubation
Date of first enrolment:	15/03/2013
Target sample size:	154
Recruitment status:	Completed
URL:	http://isrctn.com/ISRCTN57679531
Study type:	Interventional
Study design:	Interventional open-label parallel randomized controlled trial (Treatment)
Phase:	Not Applicable

Countries of recruitment
Oman

Contacts

Name:	Naresh Kaul
Address:	Senior Consultant Department of anesthesia & ICU Khoula Hospita Post Box 90 116 Muscat Oman
Telephone:
Email:
Affiliation:

Name:
Address:
Telephone:
Email:
Affiliation:

Key inclusion & exclusion criteria

Inclusion criteria:
1. Patient has been informed of the investigational nature of this study and has given verbal informed consent in accordance with Hospital Ethical Committee guidelines.
2. Males or females = 18 - 60 years of age
3. American Society of Anesthesiologist?s grade I and II patients
4. Elective surgical procedure under general anesthesia needing tracheal intubation

Exclusion criteria:
1. Pregnant female
2. Known allergies to either study devices or its components
3. Known bleeding/coagulation disorder
4. Immobilized cervical spine
5. Any pathologies of the mouth, pharynx or larynx
6. Previous ENT surgeries
7. Known malignancies prior to randomisation
8. Chronic kidney disease, chronic liver disease or heart failure

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Patients undergoing elective surgical procedure under general anesthesia needing tracheal intubation
Surgery
Tracheal intubation

Intervention(s)

Endotracheal Intubation with C-Mac?s D- blade videolaryngoscope by an experienced anesthesiologist using either of the following two intubation guides.

Study Group A: A well lubricated conventional rigid stylet (Portex) will be used to shape the ETT according to the curvature of thevideolaryngoscope blade. This preshaped ETT will be guided into the trachea after obtaining an adequate view of the glottis of an anesthetized and fully relaxed patient using C-Mac?s D- blade videolaryngoscope by an experienced anesthesiologist.

Study Group B. A well lubricated Truflex flexible stylet will be used in place of the rigid stylet to change the curvature of the ETT as per need to negotiate into the glottis of an optimally anesthetized and relaxed patient using C-Mac?s D- blade videolaryngoscope by an experienced anesthesiologist.

Primary Outcome(s)

Current primary outcome measures as of 24/09/2013:
1. Successful or failed intubation at the first attempt
2. Total Intubation Time - This shall include:
2.1. Glotticoscopy time (From introduction of the videolaryngoscope blade between the teeth to the best laryngeal view)
2.2. ETT negotiation time (From receiving the styleted ETT in laryngoscopist?s hand to passage of black line just beyond the vocal cord.
3. Intubation Difficulty Score

Previous primary outcome measures:
1. Successful or failed tracheal intubation
2. Total Intubation Time - This shall include:
2.1. Glotticoscopy time (From introduction of the videolaryngoscope blade between the teeth to the best laryngeal view)
2.2. ETT negotiation time (From receiving the styleted ETT in laryngoscopist?s hand to passage of black line just beyond the vocal cord.
3. Intubation Difficulty Score

Secondary Outcome(s)

1. Intubation attempts - maximum three attempts, after which the technique will be considered as failure. An attempt shall be counted if the laryngoscope or the ETT needs to be removed for re-oxygenation (drop in oxygen saturation by 5%) or for reshaping of the ETT.
2. Glotticoscopy time & ETT negotiation time as described in primary outcome measure above
3. Overall user satisfaction (Scale 1-10): 1-3=Poor, 4-6=Fair, 7-10=Good)
4. Cormack & Lehanne?s grading

Secondary ID(s)

U1111-1139-2029

Source(s) of Monetary Support

Investigator initiated and funded (Oman), Khoula Hospital (Oman) - Research grants from of the Department of Anesthesia & ICU

Secondary Sponsor(s)

Ethics review

Status:
Approval date:
Contact:

Ethical issues committee, Khoula Hospital, Muscat, Sultanate of Oman, 2nd March 2013, MOH/KH/EIC/2/2013

Results

Results available:	Yes
Date Posted:
Date Completed:	15/10/2013
URL:

Disclaimer: Trials posted on this search portal are not endorsed by WHO, but are provided as a service to our users. In no event shall the World Health Organization be liable for any damages arising from the use of the information linked to in this section. None of the information obtained through use of the search portal should in any way be used in clinical care without consulting a physician or licensed health professional. WHO is not responsible for the accuracy, completeness and/or use made of the content displayed for any trial record.