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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Valentin S Kozlov, MD
- Número de teléfono: +7-931-250-79-30
- Correo electrónico: kozlov.vs@47lokb.ru
Ubicaciones de estudio
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Saint Petersburg, Rusia, 194291
- Reclutamiento
- The Leningrad Regional Clinical Hospital
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Contacto:
- Valentin S Kozlov, MD
- Número de teléfono: +7-931-250-79-30
- Correo electrónico: kozlov.vs@47lokb.ru
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Sub-Investigador:
- Alexey S Rumyantsev-Aleksandrov, MD
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Investigador principal:
- Valentin S Kozlov, MD
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Comparador activo: 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.
Otros nombres:
Balanced crystalloid solutions stored at an ambient temperature of 23 °C and administered intravenously without additional warming. |
|
Experimental: 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.
Otros nombres:
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.
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Core body temperature at admission to the intensive care unit
Periodo de tiempo: At transfer to the intensive care unit, up to 12 hours after skin incision
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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
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Perioperative axillary temperature
Periodo de tiempo: 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
Periodo de tiempo: 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
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Proportion of participants requiring norepinephrine infusion
Periodo de tiempo: Intraoperative period, up to 12 hours
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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
|
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Time from skin incision to initiation of norepinephrine infusion
Periodo de tiempo: 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
|
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Norepinephrine infusion rate
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
|
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Stroke volume measured by tetrapolar impedance rheography
Periodo de tiempo: 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
|
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Cardiac output measured by tetrapolar impedance rheography
Periodo de tiempo: 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
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Change in extracellular fluid volume measured by tetrapolar impedance rheography
Periodo de tiempo: 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
|
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Base excess in venous blood
Periodo de tiempo: Postoperative day 1
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Base excess determined by venous blood gas analysis. Measured in millimoles per litre. |
Postoperative day 1
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Plasma lactate concentration
Periodo de tiempo: Postoperative day 1
|
Lactate concentration determined in venous blood. Measured in millimoles per litre. |
Postoperative day 1
|
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Serum C-reactive protein concentration
Periodo de tiempo: Postoperative day 1
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C-reactive protein concentration determined in venous blood. Measured in milligrams per litre. |
Postoperative day 1
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Total SOFA score
Periodo de tiempo: Postoperative day 1
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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
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Proportion of screened participants who were randomised
Periodo de tiempo: 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
|
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Proportion of eligible participants who provided informed consent
Periodo de tiempo: 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
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Recruitment rate
Periodo de tiempo: 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
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Adherence to the allocated intervention
Periodo de tiempo: 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
Periodo de tiempo: 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
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Completeness of data for the primary outcome measure
Periodo de tiempo: 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
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Valentin S Kozlov, MD, The Leningrad Regional Clinical Hospital
- Investigador principal: Ionas S Simutis, MD, Dsc, North-Western State Medical University named after I.I.Mechnikov
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- LOKB-TTM-2024-01
- Protocol N. 9 dated 23.10.2024 (Otro identificador: Local Ethics Committee, North-Western State Medical University named after I.I. Mechnikov)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
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.
Marco de tiempo para compartir IPD
Beginning 6 months after publication of the main results and ending 3 years thereafter.
Criterios de acceso compartido de IPD
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.
Datos del estudio/Documentos
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Protocolo de estudio
Identificador de información: OSF.IO/4GCFXComentarios de información:
Study protocol summary, version 1.0
Información sobre medicamentos y dispositivos, documentos del estudio
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