Goal-Directed Temperature Management During Prolonged Abdominal Surgery
Goal-Directed Temperature Management During Prolonged Abdominal Interventions: A Randomized Prospective Pilot Study
During long operations on the abdomen, patients often get cold. Doctors call this perioperative hypothermia. Even a small drop in body temperature can cause problems, such as more bleeding, wound infection, and a longer stay in hospital.
To keep patients warm during surgery, doctors usually blow warm air over the body through a special blanket. However, the fluids that patients receive through a vein during surgery are normally at room temperature. These cool fluids may lower the body temperature from the inside.
This study compares two ways of keeping patients warm during operations on the abdomen that last three hours or longer.
Everyone taking part receives warm air blown over the body. In addition, one group receives fluids into a vein at room temperature, about 23 °C, which is the usual practice. The other group receives the same fluids warmed to 39 °C by a special device just before the fluid enters the vein.
Participants are placed into one of the two groups by chance, like flipping a coin. Because of the nature of the treatment, the doctors caring for the patient know which group the patient is in.
The researchers measure body temperature before, during, and at the end of surgery. They also record blood pressure, the medicines used to support blood pressure, the amount of fluid given, the amount of urine produced, and blood tests taken on the day after surgery.
This is a pilot study. Its main purpose is to find out whether a larger study would be possible. The researchers want to learn how many patients can be enrolled, whether the treatment can be given exactly as planned, and how complete the collected information is. The results will be used to plan a larger study.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Design and setting.
Single-centre, randomised, parallel-group, open-label pilot trial conducted at a regional clinical hospital in Saint Petersburg, Russian Federation. Participants are allocated in a 1:1 ratio to a control group or a study group.
Anaesthesia and warming protocol.
All participants receive general anaesthesia according to a standardised institutional protocol, and ambient operating room temperature is kept constant. In both groups, forced-air warming is applied through an upper body blanket at an airflow temperature of 37 °C from induction of anaesthesia until the end of surgery. In the control group, balanced crystalloid solutions are stored at 23 °C and infused without additional warming. In the study group, the same solutions are actively warmed to a target temperature of 39 °C using a medical fluid warmer positioned as close as possible to the venous access site.
Measurements.
Axillary and oesophageal temperature are recorded before induction of anaesthesia, hourly during surgery, and at transfer to the intensive care unit. Haemodynamic variables, the use and infusion rate of norepinephrine, intraoperative crystalloid volume and urine output are recorded throughout surgery. Stroke volume, cardiac output and extracellular fluid volume are assessed by tetrapolar impedance rheography. Base excess, plasma lactate, C-reactive protein and the SOFA score are recorded on the first postoperative day.
Randomisation and allocation concealment.
The allocation sequence is generated using random number tables. Allocation is concealed by sequentially numbered, sealed, opaque envelopes, opened after eligibility is confirmed and written informed consent is obtained. Blinding of the anaesthesia team is not feasible because of the nature of the intervention.
Withdrawal criteria.
Participants are withdrawn from analysis in case of withdrawal of informed consent, errors in data recording, or intraoperative change in the extent of the planned surgical procedure.
Feasibility assessment.
In addition to the clinical outcome measures, the following feasibility parameters are recorded: the proportion of screened patients who are eligible and randomised, the proportion of eligible patients who consent, adherence to the allocated intervention, the proportion of randomised participants with analysable data, and completeness of data for the primary outcome measure. These parameters will be used to determine whether a definitive multicentre trial is feasible and to inform its sample size.
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Valentin S Kozlov, MD
- Telefonnummer: +7-931-250-79-30
- E-post: kozlov.vs@47lokb.ru
Studiesteder
-
-
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Saint Petersburg, Russland, 194291
- Rekruttering
- The Leningrad Regional Clinical Hospital
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Ta kontakt med:
- Valentin S Kozlov, MD
- Telefonnummer: +7-931-250-79-30
- E-post: kozlov.vs@47lokb.ru
-
Underetterforsker:
- Alexey S Rumyantsev-Aleksandrov, MD
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Hovedetterforsker:
- Valentin S Kozlov, MD
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-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Signed written informed consent
- Age 18 years or older
- Scheduled abdominal surgery with an expected duration of at least 3 hours
Exclusion Criteria:
- Pregnancy or breastfeeding
- End-stage chronic somatic disease
- Axillary temperature above 37.0 °C before surgery
- Documented thermoregulatory disorder of any origin, including disorders due to ongoing infectious or autoimmune disease or traumatic brain injury
- Chronic heart failure stage 2 according to the classification of the Russian Society of Cardiology
- Active infection before surgery
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Aktiv komparator: Control group
Forced-air warming applied through an upper body blanket at an airflow temperature of 37 °C from induction of anaesthesia until the end of surgery, combined with intravenous infusion of balanced crystalloid solutions stored at 23 °C and administered without additional warming. |
Forced-air warming system with an upper body blanket; airflow temperature set at 37 °C; applied identically in both groups from induction of anaesthesia until the end of surgery.
Andre navn:
Balanced crystalloid solutions stored at an ambient temperature of 23 °C and administered intravenously without additional warming. |
|
Eksperimentell: Study group
Forced-air warming applied through an upper body blanket at an airflow temperature of 37 °C from induction of anaesthesia until the end of surgery, combined with intravenous infusion of the same balanced crystalloid solutions actively warmed to a target temperature of 39 °C by a medical fluid warmer positioned as close as possible to the venous access site. |
Forced-air warming system with an upper body blanket; airflow temperature set at 37 °C; applied identically in both groups from induction of anaesthesia until the end of surgery.
Andre navn:
Balanced crystalloid solutions actively warmed to a target temperature of 39 °C using a medical fluid warmer; the infusion line is placed inside the heating element as close as possible to the venous access site.
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Core body temperature at admission to the intensive care unit
Tidsramme: At transfer to the intensive care unit, up to 12 hours after skin incision
|
Oesophageal temperature measured at the time of transfer of the participant from the operating room to the intensive care unit, in degrees Celsius. |
At transfer to the intensive care unit, up to 12 hours after skin incision
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Perioperative axillary temperature
Tidsramme: Before induction of anaesthesia, hourly during surgery, and at admission to the intensive care unit, up to 12 hours
|
Axillary temperature measured with a contact thermometer. Measured in degrees Celsius. |
Before induction of anaesthesia, hourly during surgery, and at admission to the intensive care unit, up to 12 hours
|
|
Perioperative oesophageal temperature
Tidsramme: Hourly from 1 hour after start of surgery until admission to the intensive care unit, up to 12 hours
|
Core temperature measured with an oesophageal probe. Measured in degrees Celsius. |
Hourly from 1 hour after start of surgery until admission to the intensive care unit, up to 12 hours
|
|
Proportion of participants requiring norepinephrine infusion
Tidsramme: Intraoperative period, up to 12 hours
|
Number of participants who received an intraoperative norepinephrine infusion, divided by the number of participants analysed in the group, expressed as a percentage. |
Intraoperative period, up to 12 hours
|
|
Time from skin incision to initiation of norepinephrine infusion
Tidsramme: Intraoperative period, up to 12 hours
|
Interval between skin incision and the start of norepinephrine infusion, assessed only in participants who received norepinephrine. Measured in minutes. |
Intraoperative period, up to 12 hours
|
|
Norepinephrine infusion rate
Tidsramme: Intraoperative period, up to 12 hours
|
Rate of intraoperative norepinephrine infusion, assessed only in participants who received norepinephrine. Measured in micrograms per kilogram per minute. |
Intraoperative period, up to 12 hours
|
|
Volume of intraoperative crystalloid infusion
Tidsramme: From skin incision to end of surgery, up to 12 hours
|
Total volume of balanced crystalloid solutions administered intravenously during surgery. Measured in millilitres. |
From skin incision to end of surgery, up to 12 hours
|
|
Intraoperative urine output
Tidsramme: From skin incision to end of surgery, up to 12 hours
|
Total volume of urine collected during surgery. Measured in millilitres. |
From skin incision to end of surgery, up to 12 hours
|
|
Stroke volume measured by tetrapolar impedance rheography
Tidsramme: From before induction of anaesthesia, hourly during surgery, up to 12 hours
|
Stroke volume assessed non-invasively by tetrapolar impedance rheography. Measured in millilitres. |
From before induction of anaesthesia, hourly during surgery, up to 12 hours
|
|
Cardiac output measured by tetrapolar impedance rheography
Tidsramme: From before induction of anaesthesia, hourly during surgery, up to 12 hours
|
Cardiac output assessed non-invasively by tetrapolar impedance rheography. Measured in litres per minute. |
From before induction of anaesthesia, hourly during surgery, up to 12 hours
|
|
Change in extracellular fluid volume measured by tetrapolar impedance rheography
Tidsramme: From start of surgery to end of surgery, up to 12 hours
|
Relative change in extracellular fluid volume assessed by tetrapolar impedance rheography. Expressed as a percentage. |
From start of surgery to end of surgery, up to 12 hours
|
|
Base excess in venous blood
Tidsramme: Postoperative day 1
|
Base excess determined by venous blood gas analysis. Measured in millimoles per litre. |
Postoperative day 1
|
|
Plasma lactate concentration
Tidsramme: Postoperative day 1
|
Lactate concentration determined in venous blood. Measured in millimoles per litre. |
Postoperative day 1
|
|
Serum C-reactive protein concentration
Tidsramme: Postoperative day 1
|
C-reactive protein concentration determined in venous blood. Measured in milligrams per litre. |
Postoperative day 1
|
|
Total SOFA score
Tidsramme: Postoperative day 1
|
Sequential Organ Failure Assessment score, calculated as the sum of six organ system subscores. Total score ranges from 0 to 24, with higher scores indicating greater organ dysfunction. |
Postoperative day 1
|
Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Proportion of screened participants who were randomised
Tidsramme: From start of enrolment through study completion, up to 32 months
|
Feasibility outcome. Number of randomised participants divided by the number of patients screened for eligibility, expressed as a percentage. |
From start of enrolment through study completion, up to 32 months
|
|
Proportion of eligible participants who provided informed consent
Tidsramme: From start of enrolment through study completion, up to 32 months
|
Feasibility outcome. Number of participants who provided written informed consent divided by the number of patients who met the eligibility criteria, expressed as a percentage. |
From start of enrolment through study completion, up to 32 months
|
|
Recruitment rate
Tidsramme: From start of enrolment through study completion, up to 32 months
|
Feasibility outcome. Number of randomised participants per month of enrolment. |
From start of enrolment through study completion, up to 32 months
|
|
Adherence to the allocated intervention
Tidsramme: From start of enrolment through study completion, up to 32 months
|
Feasibility outcome. Number of randomised participants who received the allocated intervention in full, divided by the number of randomised participants, expressed as a percentage. |
From start of enrolment through study completion, up to 32 months
|
|
Proportion of randomised participants with analysable data
Tidsramme: From start of enrolment through study completion, up to 32 months
|
Feasibility outcome. Number of randomised participants whose data were available for analysis of the clinical outcome measures, divided by the number of randomised participants, expressed as a percentage. |
From start of enrolment through study completion, up to 32 months
|
|
Completeness of data for the primary outcome measure
Tidsramme: From start of enrolment through study completion, up to 32 months
|
Feasibility outcome. Number of analysed participants with a recorded value of the primary outcome measure, divided by the number of analysed participants, expressed as a percentage. |
From start of enrolment through study completion, up to 32 months
|
Samarbeidspartnere og etterforskere
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Valentin S Kozlov, MD, The Leningrad Regional Clinical Hospital
- Hovedetterforsker: Ionas S Simutis, MD, Dsc, North-Western State Medical University named after I.I.Mechnikov
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- LOKB-TTM-2024-01
- Protocol N. 9 dated 23.10.2024 (Annen identifikator: Local Ethics Committee, North-Western State Medical University named after I.I. Mechnikov)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
De-identified individual participant data underlying the published results will be made available to qualified researchers upon reasonable request to the corresponding author, following approval of a methodologically sound proposal.
IPD-delingstidsramme
Beginning 6 months after publication of the main results and ending 3 years thereafter.
Tilgangskriterier for IPD-deling
Requests should be directed to the corresponding author and will be evaluated on the basis of scientific merit. Data will be shared after approval of a proposal and completion of a data access agreement.
Studiedata/dokumenter
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Studieprotokoll
Informasjonsidentifikator: OSF.IO/4GCFXInformasjonskommentarer:
Study protocol summary, version 1.0
Legemiddel- og utstyrsinformasjon, studiedokumenter
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