Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201808699072894 Date of Approval: 29/08/2018
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title GlideScope® cobalt video laryngoscope versus direct Miller laryngoscope for lateral position-tracheal intubation in neonates with myelodysplasia: A prospective randomized study
Official scientific title GlideScope® cobalt video laryngoscope versus direct Miller laryngoscope for lateral position-tracheal intubation in neonates with myelodysplasia: A prospective randomized study
Brief summary describing the background and objectives of the trial Anesthesiologists encounter difficulties during laryngoscopy and tracheal intubation of neonates with myelodysplasia. Tracheal intubation in the lateral position in such cases deemed profitable but not easy because of the compromised laryngeal view. We compared Glidescope video laryngoscope (GVL) versus conventional Miller direct laryngoscope (DL) for tracheal intubation in laterally positioned neonates with myelodysplasia
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,Neonatal Diseases,Nervous System Diseases,Paediatrics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Devices
Anticipated trial start date 01/08/2016
Actual trial start date 01/08/2016
Anticipated date of last follow up 31/05/2018
Actual Last follow-up date 31/05/2018
Anticipated target sample size (number of participants) 72
Actual target sample size (number of participants) 60
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group direct laryngoscope using Miller blade size 0 after induction of anesthesia for the whole surgery direct laryngoscope using Miller blade size 0 was used for intubation before surgery 30 Active-Treatment of Control Group
Experimental Group GlideScope video laryngoscope after induction of anesthesia for the whole surgery GlideScope cobalt video laryngoscope is used for intubation before surgery 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
American society anesthesiology (ASA) physical status I or II neonate patients (age ≤ 28 days) with normal craniofacial anatomy presenting for elective surgical repair of meningeocele or meningeomyelocele under general anesthesia presence of suspected difficult intubation, high risk of pulmonary aspiration, and hemodynamic instability New born: 0 Day-1 Month 1 Day(s) 28 Day(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 15/07/2016 local ethical committee of faculty of medicine of tanta uinversity
Ethics Committee Address
Street address City Postal code Country
elgeish street Tanta 31511 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The laryngeal view graded by the POGO scores once the best glottis exposure had been announced
Secondary Outcome TBGV, TPT, IT, POGO scores after OLEM, intubation attempts, and overall success rate of intubation at intubation, at end of surgery i.e.at extubation
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
tanta University hospital Elgeish street tanta 31511 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor faculty of medicine of tanta university elgeish street tanta 31511 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Eman Salama moheb street Tanta Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Public Enquiries Nagat Elshmaa nagat_elshmaa@yahoo.com 00201211865637 elbahr street
City Postal code Country Position/Affiliation
Tanta Egypt assistant professor of anaesthesiology
Role Name Email Phone Street address
Scientific Enquiries Mohamed Elkashlan mohamedkashlan@yahoo.com 00201222337746 Elmotasem street
City Postal code Country Position/Affiliation
Tanta Egypt specialist of anaesthesiology
Role Name Email Phone Street address
Principal Investigator Doaa El Amrousy doaamoha@yahoo.com 00201278155283 Elmotasem street
City Postal code Country Position/Affiliation
Tanta Egypt assistant professor of pediatrics
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Undecided
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information