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.: PACTR201502000993337 Date of Approval: 12/01/2015
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title safe intubation for cervical spine patients
Official scientific title DEGREE OF CERVICAL MOBILITY DIFFERS OR NOT WHEN USING ALTERNATIVE WAY OF INTUBATION :INTUBATING LARYNGEAL MASK OR CASSIC LARYNGOSCOPE
Brief summary describing the background and objectives of the trial Background: spine surgery needs a special consideration as regard minimizing the movement during intubation to avoid the hazards to spinal cord. The present study aims to highlight the preferable technique for cervical intubation. The Intubating Laryngeal Mask Airway (ILMA, FastrachTM laryngeal mask company, Henle-on-Thomes, U.K) is a supraglottic device specially designed to be an effective ventilator device and blind intubation guide in patient with normal and abnormal airways.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied intubation,cervical spine,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 01/01/2013
Actual trial start date 01/01/2013
Anticipated date of last follow up 01/12/2013
Actual Last follow-up date 01/12/2013
Anticipated target sample size (number of participants) 40
Actual target sample size (number of participants) 40
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 randomisation using a randomisation table created by a computer software program Sealed opaque envelopes Masking/blinding used
Parallel: different groups receive different interventions at same time during study Randomised simple randomisation using a randomisation table created by a computer software program Sealed opaque envelopes Masking/blinding used Care giver/Provider,Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group macintosh laryngoscopy vedio flouroscopy recorded during intubation with macintosh laryngoscopy 20 Active-Treatment of Control Group
Experimental Group intubating laryngeal mask vedio flouroscopy recorded during intubation with intubating laryngeal mask 20
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Age range from 18-65 years 2. Weight 50-120 Kg 3. Height >150 cm 4. ASA class I or II 5. Airway score <4 according to EL Ganzouri scoring system 6. Fasting patients 1. Patients with BMI more than 35 Kg/m2 2. Patients age above 65 years 3. Airway score ¿ 4(EL Ganzouri scoring system) 4. Any chest or cardiac condition that interferes with safe general anesthesia (chest infection, COPD, Bronchial asthma) 5. Any anatomical abnormalities in the head and neck that interfere with intubation . 6. Trauma patients 18 Year(s) 65 Year(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 01/04/2013 kasr alainy ethical committee
Ethics Committee Address
Street address City Postal code Country
kasr alainy street cairo Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome decrease incidence of cervical spine injury during intubation Change in angles C1/C2 and C2/C3before, during and after intubation.
Secondary Outcome stable hemodynamics during intubation change in blood pressure change in heart rate change in oxygen saturation
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
kasr alainy kasr alainy street cairo Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
cairo university giza Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor KASR ALAINY kasr alainy street cairo Egypt Hospital
Primary Sponsor cairo university GIZA Egypt University
COLLABORATORS
Name Street address City Postal code Country
HISHAM KHEDR OMAN STREET MOHANDESEEN Egypt
GOMAA ZOHRY EL FARIK ALI FAHMY STREET GIZA Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator MAGDA SALEH gloria-gloria4@hotmal.com 01278122221 202 street , degla
City Postal code Country Position/Affiliation
cairo Egypt kasr alainy
Role Name Email Phone Street address
Public Enquiries GOMAA ZOHRY gomaaneel@hotmail.com 01140333553 EL FARIK ALI FAHMY STREET,HARM
City Postal code Country Position/Affiliation
GIZA Egypt kasr alainy
Role Name Email Phone Street address
Scientific Enquiries HISHAM KHEDR uelgameel@hotmail.com 01001622640 OMAN STREET MOHANDESEEN
City Postal code Country Position/Affiliation
giza Egypt kasr alainy
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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