Effect of Preoperative Active Warming and Passive Warming Methods on Perioperative Hypothermia

NCT04997694 | Completed DMC

• 1 other identifier: 0000-0001-8907-0651
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

70% of surgical interventions are abdominal surgeries. Open abdominal surgery is performed in patients for whom minimally invasive approaches are not suitable. In these surgeries in which general anesthesia is used, the duration of the operation is longer, complications are more frequent, and postoperative recovery occurs later. Low body temperature before surgery, preoperative fasting and fluid deprivation before anesthesia, exposure of large body surface areas, evaporative heat loss during skin preparation using volatile solutions, large open cavity or abdominal surgery longer operative time and exposure to anesthesia, during surgical intervention excessive blood loss etc. surgical intervention poses a risk for the formation of undesirable hypothermia. Cardiovascular and respiratory system problems that may increase mortality due to hypothermia in surgical patients; may cause a decrease in heart rhythm, cardiac output, blood pressure and oxygen saturation, and an increased risk of cardiac arrest and ischemia. With the development of shivering, oxygen consumption increases and the "thermal comfort" of the patient deteriorates. The length of stay in the postoperative unit and hospital stay are prolonged, causing an increase in costs. Among the rapid recovery protocols, it is recommended to pre-warm the patients in the preoperative period to maintain normothermia. Many complications are prevented by different methods and warming procedures performed in the perioperative period. In our study, it was aimed to compare the effects of active and passive warming on hypothermia, vital signs and warmth comfort in the postoperative period in patients who will undergo open abdominal surgery.

Conditions

Hypothermia; Perioperative Care; Vital Signs; Rewarming

Outcome Measures

Primary Outcomes (1)

• changes in body temperature preheating process

  The sample size was calculated by performing G-power power analysis. Pre-application measurements and 0., 15., 30. after application. Considering the temperature changes observed in the measurements obtained per minute, the effect size was found to be 0.1844. Accordingly, the number of samples required to achieve 90% power at α=0.05 level was calculated as 78 patients, including at least 26 active warming groups, 26 passive warming groups, and 26 control groups. In order to increase the power of the research, the study was conducted with a total of 90 patients, 30 from each group. Participants with a body temperature below 36 0C were considered to be in hypothermia. Non-contact thermometer was used to measure body temperature.

  30 minutes

Study Arms (3)

Active Heating Group

EXPERIMENTAL

When the participants comes to the preoperative unit before the operation, vital signs, temperature comfort perception scale and shivering level, temperature and humidity measurements of the room are measured by the investigator and Personal Information Form Vital Signs Follow-up Form, Temperature Comfort Perception Scale- The form was recorded in the Shivering Level Diagnosis Form Filling.Before anesthesia was given, heating was performed with the 3M Bair Hugger Model 775 Heating Unit, which has an active heating system, for 20 minutes. The participants, whose surgery was completed, was taken to the postoperative recovery unit, where the vital signs, tremor level, temperature and humidity of the room were measured by the investigator and the Personal Information Form Vital Signs Follow-up Form Shivering Level Diagnosis Form was recorded. One participant was followed every 15 minutes until the body temperature reached 36 0C.

Procedure: Pre Heating

Pasive Heating Group

EXPERIMENTAL

When the participants comes to the preoperative unit before the operation, vital signs, temperature comfort perception scale and shivering level, temperature and humidity measurements of the room are measured by the investigator and Personal Information Form ,Vital Signs Follow-up Form, Temperature Comfort Perception Scale. The form was recorded in the Shivering Level Diagnosis Form . Before anesthesia was given, heating was performed with a wool blanket, which is a passive heating method, for 20 minutes. The participants, whose surgery was completed, was taken to the postoperative recovery unit, where the vital signs, tremor level, temperature and humidity of the room were measured by the investigator and the Personal Information Form Vital Signs Follow-up Form , Shivering Level Diagnosis Form was recorded. One participant was followed every 15 minutes until the body temperature reached 36 0C.

Procedure: Pre Heating

Control Group

NO INTERVENTION

When the participants comes to the preoperative unit before the operation, vital signs, temperature comfort perception scale and shivering level, temperature and humidity measurements of the room are measured by the investigator and Personal Information Form Vital Signs Follow-up Form , Temperature Comfort Perception Scale The form was recorded in the Shivering Level Diagnosis Form the participants, whose surgery was completed, was taken to the postoperative recovery unit, where the vital signs, tremor level, temperature and humidity of the room were measured by the investigator and the Personal Information Form , Vital Signs Follow-up Form , Shivering Level Diagnosis Form was recorded. One participant was followed every 15 minutes until the body temperature reached 36 0C.

Interventions

Pre Heating PROCEDURE

Before anesthesia was given, the participants were warmed for 20 minutes with prewarming techniques. Presence of postoperative hypothermia, vital signs and temperature comfort level were evaluated.

Also known as: Pre Warming

Active Heating Group; Pasive Heating Group

Eligibility Criteria

• Age: 18 Years - 88 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years and older,
• Patients with ASA III and below,
• Under elective general anesthesia, will undergo Open Abdominal Surgery,
• BMI of 18.5- 29.9 kg/m2,
• Without neurological, psychiatric, neuromuscular disease,
• Not addicted to alcohol and drugs,
• Not mentally retarded,
• Does not use drugs that will affect thermoregulation such as vasodilators,
• No history of thyroid disease,
• Absence of body temperature of 36 0C and 37.5 0C on the morning of the operation,
• No complication developed during the surgical intervention and no blood transfusion was performed.

You may not qualify if:

• Refusal to participate in the research
• Complication developed during the operation

Sponsors & Collaborators

• Cukurova University: lead

Study Sites (1)

Cukurova University

Sariçam, Adana, Turkey (Türkiye)

Location

Related Publications (1)

• Akpolat R, Arslan S. Effect of Prewarming on Postoperative Hypothermia, Vital Signs, and Thermal Comfort: A Randomized Controlled Trial. Ther Hypothermia Temp Manag. 2024 Jun;14(2):89-98. doi: 10.1089/ther.2023.0017. Epub 2023 Jun 16.

  PMID: 37327382 DERIVED

MeSH Terms

Conditions

Hypothermia

Condition Hierarchy (Ancestors)

Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Refiye Akpolat

  Cukurova University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 3 Group randomized

Study Record Dates

• First Submitted: June 23, 2021
• First Posted: August 10, 2021
• Study Start: June 23, 2021
• Primary Completion: July 23, 2021
• Study Completion: September 18, 2021
• Last Updated: March 9, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)