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.: PACTR202308575267647 Date of Approval: 24/08/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Intraoperative Use of High Flow Nasal Cannula (HFNC) in Elderly Patients
Official scientific title Intraoperative Use of High Flow Nasal Cannula (HFNC) in Elderly Patients Undergoing Hip Fracture Repair Under Spinal Anesthesia: a Randomized Controlled Study
Brief summary describing the background and objectives of the trial Hip fracture repair are known to have a considerable moribidity and mortality, because of postoperative complications, mainly respiratory and cardiovascular ones. The risk is higher in elderly patients because of age related chronic conditions and polypharmacy. Thus, many interventions have been suggested to reduce postoperative complications such as prophylactic non invasive ventilation, which has been included in many strategies of enhanced recovery after surgery. Recently, many case reports highlighted the intraoperative use of non invasive ventilation in hypoxemic patients undergoing surgeries under spinal anesthesia. This intervention can be used for prophylactic reasons in non hypoxemic patients. However, it doesn’t seem to be comfortable enough. That’s why; the use of high flow nasal canula seems to be more relevant in this context. It acts essentially through its PEEP effect. However, this HFNC interest must be firstly assessed by scientific studies. Te aim of this study is to assess the impact of intraoperative use of high flow nasal canula on elderly patients outcome after hip fracture repair.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,Orthopaedics,Respiratory,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 01/07/2023
Actual trial start date 01/08/2023
Anticipated date of last follow up 30/08/2023
Actual Last follow-up date
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants)
Recruitment status Recruiting
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 Numbered containers Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group HFNC group Intraoperatively Elderly Patients undergoing hip fracture repair will have Intraoperative use of high flow nasal canula 30
Control Group Control Group Intraoperatively No intraoperative intervention for this group 30 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• age ≥ 65 years • Isolated Hip Fracture • Patient Consent. • Hip fracture repair under spinal anesthesia • refusal of spinal anesthesia, • contraindications to spinal anesthesia and/or HFNC • conversion to general anesthesia. 80 and over: 80+ Year,Aged: 65+ 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 12/04/2023 Sahloul Ethics committee
Ethics Committee Address
Street address City Postal code Country
Sahloul Sousse 4011 Tunisia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome incidence of postoperative pulmonary complications At hospital discharge
Secondary Outcome Need for postoperative oxygen therapy During the postoperative period
Secondary Outcome ICU admission During the postoperative period
Secondary Outcome Length of hospital stay At hospital discharge
Secondary Outcome Mortality In hospital
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Sahloul Teaching Hospital Route de la ceinture Sousse 4011 Tunisia
FUNDING SOURCES
Name of source Street address City Postal code Country
Sahloul Teaching Hospital Route de la ceinture Sousse 4011 Tunisia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of medecine of Sousse Rue Mohamed Karoui Sousse 4002 Tunisia University
COLLABORATORS
Name Street address City Postal code Country
Majid Fakhir Mutar AL Hamaidah Refaii Dhi Qar 64001 Iraq
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mohamed Kahloul med.kahloul@outlook.fr +21623567317 Sahloul
City Postal code Country Position/Affiliation
Sousse 4011 Tunisia Sahloul Teaching Hospital Faculty of medecine of Sousse
Role Name Email Phone Street address
Public Enquiries Karim Bouattour kbouattourfr@yahoo.fr +21698462512 Route de la ceinture Sahloul
City Postal code Country Position/Affiliation
Sousse 4011 Tunisia Sahloul Teaching Hospital Faculty of medecine of Sousse
Role Name Email Phone Street address
Scientific Enquiries Walid Naija walidnaija@yahoo.fr +21696162001 Route de la ceinture Sahloul
City Postal code Country Position/Affiliation
Sousse 4011 Tunisia Sahloul Teaching Hospital Faculty of medecine of Sousse
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data will be available. It will include the entire individual participant data collected during the trial, after deidentification. The study protocol, the statistical analysis plan, the informed consent form and the clinical study report will also be available. All these documents will be shared with researchers who provide a methodologically sound proposal, for any purpose. Proposals should be directed to med.kahloul@outlook.fr. To gain access, data requestors will need to sign a data access agreement. Informed Consent Form,Statistical Analysis Plan,Study Protocol IPD will be shared during a 24-month period, beginning 9 months after article publication. high flow nasal canula elderly hip fracture postoperataive respiratory complications
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