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.: PACTR202002541648874 Date of Approval: 10/02/2020
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Efficacy of forced air warming versus warmed irrigation fluids for prevention of hypothermia and shivering during transurethral resection of prostate under spinal anesthesia
Official scientific title Efficacy of forced air warming versus warmed irrigation fluids for prevention of hypothermia and shivering during transurethral resection of prostate under spinal anesthesia
Brief summary describing the background and objectives of the trial Perioperative hypothermia is an accidental decrease in core body temperature < 36 °C during intra or immediately postoperative period (1). Impairment of thermoregulatory mechanism that is resulted from anesthesia, surgical factors and environmental conditions in the operating theatre are the main causes of perioperative hypothermia (2). Heat redistribution from the core to the periphery secondary to anesthesia induced vasodilation is the most important cause of perioperative hypothermia (3). The temperature gradient between the core and the peripheral compartments quantifies the amount of heat redistribution (4). Skin pre warming with forced air warming system before induction of anesthesia can decrease this gradient by increasing the heat content of the peripheral tissue (5). Perioperative hypothermia can lead to detrimental sequels such as blood loss, surgical wound infection, myocardial ischemia and delayed recovery from anesthesia (6). Transurethral resection of prostate (TURP) is very common surgical procedure of elderly male. Many TURP patients have chronic pulmonary or cardiac diseases (7). Hypothermia and subsequent shivering are very common during TURP surgery. The TURP procedure entails bladder irrigation with large amounts of irrigation fluids that result in heat loss and drop of core body temperature by 1-2°C (7). Warming of irrigation fluids in many studies was proven to prevent drop of body temperature during TURP (8). pre-operative warming of skin surface using forced –air warming devices for different short periods of times were examined in different studies. It has been reported to decrease the temperature gradient and heat redistribution between the core and the periphery with subsequent reduction of shivering and prevention of hypothermia (9).
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 Supportive care
Anticipated trial start date 15/12/2019
Actual trial start date
Anticipated date of last follow up 01/07/2020
Actual Last follow-up date
Anticipated target sample size (number of participants) 120
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Intraoperative forced air warming group Intraoperative With the beginning of the surgery active warming group patients will received active warming with forced air blanket (BAIR- HUGGER-USA). The blanket will cover neck, chest, abdomen till umbilicus and thigh. The thermostat of the warmer will be set at 38 °C,Patients of this group will receive irrigation fluids kept at room temperature. 60
Control Group intraoperative warmed irrigation fluids group intraoperative with the beginning of the surgery, patients will receive only warmed irrigation fluids that will continue during surgical procedure. They will be warmed by using water bath warmed incubator and kept at constant temperature of the incubator at 38 °C. 60 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
American Society of Anesthesiologists (ASA) physical status grade I-II. Patients with chronic major respiratory, Cardiovascular or endocrinal diseases, electrolyte abnormality, preoperative anemia, fever (core temperature >37.5 °C), preoperative coagulopathy or on anticoagulant therapy will be excluded. Aged: 65+ Year(s) 60 Year(s) 80 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 24/11/2019 Research ethics committee for human subject research at faculty of medicin Helwan university Cairo Egypt
Ethics Committee Address
Street address City Postal code Country
Al Gamaa, Al Masaken Al Iqtisadeyah cairo 11795 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Primary outcomes will be core temperature changes During the intraoperative period and incidence of hypothermia
Secondary Outcome The secondary outcomes will be the incidence and severity of shivering during intraoperative period
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Andalusia Smouha hospital smouha Alexandria Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
dr.tarek ismail 152 tiba st. sporting alexandria 21617 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Dr tarek ismail sabry mohamed 152 TIBA st. sporting alexandria 21617 Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
Mohamrd Hassan Ali Soliman Al Gamaa, Al Masaken Al Iqtisadeyah, Qism Helwan Helwan Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator tarek ismail sabry mohamed ismail drtarek.anesth@gmail.com 00201001467166 152 tiba st. sporting
City Postal code Country Position/Affiliation
alexandria 21617 Egypt lecturer of anesthesia
Role Name Email Phone Street address
Public Enquiries Hanan Mina hananminaped@gmail.com 00201203032096 Al Gamaa, Al Masaken Al Iqtisadeyah, Qism Helwan
City Postal code Country Position/Affiliation
cairo Egypt Lecturer of pediatrics Faculty of medicin Helwan university Cairo Egypt
Role Name Email Phone Street address
Scientific Enquiries tarek salem tareksalem00@gmail.com 00201112277417 Al Gamaa, Al Masaken Al Iqtisadeyah, Qism Helwan
City Postal code Country Position/Affiliation
cairo Egypt Vice Dean of Graduat Studies and Research
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes patients data after data entry in excel sheets. Statistical Analysis Plan,Study Protocol additional documents will be available within 12 months after completion of the study. open access to IPD to reviewers. Data will be send directly by email upon request.
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