Effects of Different Warming Methods in Laparoscopic Cholecystectomy Surgery

NCT ID: NCT04741815

Last Updated: 2022-03-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 123 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-22
• Study Completion Date: 2021-04-30

Brief Summary

Cold gases given during laparoscopic cholecystectomy are the most important cause of hypothermia. However, even surgery alone is an 80% important cause of hypothermia. Inadvertent perioperative hypothermia is a common complication of the surgical process that can cause serious complications. In most of the patients, tremors, increase in pain, deterioration in comfort and changes in some physiological parameters can be seen. Despite this, there are not enough warming devices that nurses can use practically and are easy to use, affordable and comfortable for the patient. In the literature, it is stated in the evidence-based guidelines for determining the hypothermia risks of patients and taking early precautions.

Detailed Description

The parallel group randomized controlled three group study blinded by the evaluator aims to investigate the effectiveness of different warming methods in laparoscopic cholecystectomy patients. This study general surgery at Yozgat Bozok University Hospital in Turkey are performed in clinics. All patients are male and female patients who have undergone surgery and met the inclusion criteria.

Conditions

Inadvertent Perioperative Hypothermia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Forced Air Warming Group

There is no intervention in patients before the operation. When he comes out of the operation and comes to the post-anesthesia care unit (PACU), he is warmed by forced air. When the body temperature of the patients reaches 36 ° C, they are transferred to the clinic with a cover and blanket.

Group Type: EXPERIMENTAL

Forced Air Warming

Intervention Type: DEVICE

It consists of the WarmAir® unit and FilteredFlo® blankets. FilteredFlo® blankets are a cover designed to cover the entire body and extremities with air channels that provide the appropriate distribution of patient warm. The WarmAir® warming device connected to the shroud via a pipe; it has three temperature settings, 32.2 C, 37.8 C, and 43.3 C.

Peripheral Carbon Fiber Warming Group

Gloves and socks developed by the researcher are applied half an hour before the operation. These materials, called environmental warming, have three layers. The first layer in contact with the patient is a thermal inner sheath made of 90% Polyester and 10% Polyamide and is used to maintain body temperature. The second layer consists of carbon fiber warmer and foil. The end of the carbon fiber warmer is USB connected. When the connection is plugged in, the warmer works. The third layer is again made of thermal fabric. A rubber bandage is made to separate the last layer from the external environment and to maintain the patient's body temperature. The USB connection is removed while patients are sent for surgery. After the operation, rewarming is started in the post-anesthesia care unit. When the patient's body temperature reaches 36 ° C, he is transferred to the clinic with a cover and blanket.

Group Type: EXPERIMENTAL

Peripheral Carbon Fiber Warming

Intervention Type: DEVICE

It was developed by the researcher. Designed as gloves and socks, these warming materials have three layers. The first layer in contact with the patient and the third layer in contact with the external environment is a thermal material to maintain body temperature. The second floor consists of a USB-connected carbon fiber warmer and foil.

Control Group

A routine hospital procedure is applied. The patient is not warmed before going to surgery. A cover and blanket are used passively after being taken to the PACU from the operation.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Forced Air Warming

It consists of the WarmAir® unit and FilteredFlo® blankets. FilteredFlo® blankets are a cover designed to cover the entire body and extremities with air channels that provide the appropriate distribution of patient warm. The WarmAir® warming device connected to the shroud via a pipe; it has three temperature settings, 32.2 C, 37.8 C, and 43.3 C.

Intervention Type: DEVICE

Peripheral Carbon Fiber Warming

It was developed by the researcher. Designed as gloves and socks, these warming materials have three layers. The first layer in contact with the patient and the third layer in contact with the external environment is a thermal material to maintain body temperature. The second floor consists of a USB-connected carbon fiber warmer and foil.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Patients are qualified to answer research questions,
• BMI is between 18.5 kg / m2 and 30 kg / m2,
• Not using therapeutic hypothermia in the surgery,
• Not being treated with chronic opioids,
• Operation time is between 60 minutes and 6 hours,
• Having received general anesthesia during the operation,
• Reception of patients with ASA classification I or II,
• Absence of anemia, coagulation problem and peripheral circulatory disease or metabolic disease.

Exclusion Criteria

• Intraoperative and postoperative have complications (bleeding, arrest, nausea, vomiting, etc.),
• Conversion of surgery from laparoscopy to open surgery.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ataturk University

OTHER

Sponsor Role: collaborator

Bozok University

OTHER

Sponsor Role: lead

Responsible Party

Aybike Bahçeli

Research Asistant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Yozgat Bozok University Health Sciences Faculty

Yozgat, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

2018-3/16

Identifier Type: -

Identifier Source: org_study_id