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 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202010891239155 Date of Registration: 29/10/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Hemodynamic response to oro-tracheal intubation in elderly patients: Direct laryngoscopy using Macintosh blades versus McGrath® video-laryngoscopy - a randomized clinical trial
Official scientific title McGrath® Versus Macintosh laryngoscopes on hemodynamic response to intubation in elderly patients.
Brief summary describing the background and objectives of the trial Laryngoscopie may trigger many complications in response to an intense hemodynamic variation especially in fragile elderly patients. The aim of this study is to determine whether there is a significant difference between the hemodynamic response to orotracheal intubation by McGrath® compared to the Macintosh laryngoscope in the elderly and to secondarily assess postoperative laryngeal morbidity.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 01/11/2020
Actual trial start date 01/12/2020
Anticipated date of last follow up 31/12/2020
Actual Last follow-up date 01/04/2021
Anticipated target sample size (number of participants) 52
Actual target sample size (number of participants) 78
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 Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Macintosh blade laryngoscope Only one time: for intubation - first attempt.. The time needed for oro-tracheal intubation. After the induction protocol, oro-tracheal intubation is made by a trained operator using a classic Macintosh blade number 3 for female and number 4 for male patients. 26 Historical
Experimental Group McGrath videolaryngoscopy Only one time: for intubation - first attempt. The time needed for oro-tracheal intubation. After the induction protocol, oro-tracheal intubation is made by a trained operator using McGrath® videolaryngoscopy with a blade number 3 for female and number 4 for male patients. 26
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
- Age > 65 years. - ASA Physical Status Score 1 or 2. - Elective surgery with general anesthesia and oro-tracheal intubation. - Predicted operative time exceeding 30 minutes. - Patient refusal or withdraw of consent. - urgent surgery. - Difficult airway management. - Pre-operative hemodynamic instability. - Suspicion of cerebral injury or intra-cranial hyper-tension. 80 and over: 80+ Year,Aged: 65 Year(s)-79 Year(s) 65 Year(s) 100 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 24/10/2020 CNEM
Ethics Committee Address
Street address City Postal code Country
Institut Pasteur de Tunis , 1002 TUNIS BELVEDERE tunis 1002 Tunisia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The primary outcome is the increase in Systolic Blood Pressure (SBP), or Mean (MAP) after laryngoscopy, objectified by a difference in SBP (DiffPAS = PASmax - PAS (T1)) or a difference in MAP ( DiffPAM = PAMmax - PAM (T1)) greater than or equal to 20 mm / Hg between groups in the five minutes after the start of laryngoscopy. Fifth minute after the start of laryngoscopy
Secondary Outcome We will observe the difference in Heart Rate (DiffFC = HRmax - HR (T1)), i.e. the difference between the peak heart rate and the heart rate before the start of laryngoscopy) greater than or equal to 20 bpm. Fifth minute after the start of laryngoscopy.
Secondary Outcome We will observe the onset of major cardiac events: myocardial ischemia objectified by a change in the ST segment, arrhythmias (atrial and ventricular arrhythmias, bradycardia) and asystole. after the fifth minute following intubation.
Secondary Outcome Postoperative laryngeal morbidity, including sore throat and hoarseness, will be assessed by a different anesthesiologist from the one who performed the laryngoscopy. The score to be used have four levels of assessment: 0 = absent, 1 = mild, 2 = moderate, 3 = severe After the emergence of anesthesia and in the recovery unit.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Centre Hospitalo universitaire Habib Bourguiba Sfax AlFirdaws Sfax 3029 Tunisia
FUNDING SOURCES
Name of source Street address City Postal code Country
Mahdi Fourati Rte Ain Km 2,5 Sfax 3029 Tunisia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Mahdi Fourati Rte Ain Km 2,5 Sfax 3002 Tunisia Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mahdi Fourati mahdifourati4593@gmail.com 20917989 Rte Ain
City Postal code Country Position/Affiliation
Sfax 3002 Tunisia Anesthesiology and Intensive care RESIDENT CHU Habib Bourguiba Sfax
Role Name Email Phone Street address
Public Enquiries Yassine Maktouf yassine.maktouf@gmail.com 0021629442333 AlFirdawa
City Postal code Country Position/Affiliation
Sfax 3024 Tunisia Anesthesiology and Intensive care RESIDENT
Role Name Email Phone Street address
Public Enquiries Salma Ketata slayma@gmail.com +216290348 Teniour
City Postal code Country Position/Affiliation
Sfax 3024 Tunisia Anesthesiology Assistant CHU Habib Bourguiba Sfax
Role Name Email Phone Street address
Scientific Enquiries Abdelhamid Karoui abdelhamid.karoui@gmail.com +21658115763 AlFirdaws
City Postal code Country Position/Affiliation
Sfax 3024 Tunisia Head of Department of anesthesiology and ICU Hopital Habib Bourguiba Sfax
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol Beginning 3 months and ending 5 years following article publication Researchers who provide a methodologically sound proposal
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