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NCT Number: NCT04741815

Effects of Different Warming Methods in Laparoscopic Cholecystectomy Surgery

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.

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Key information

Conditions

Inadvertent Perioperative Hypothermia Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yozgat Bozok University Health Sciences Faculty

Yozgat, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Forced air warming

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

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.

Primary outcomes

  1. Pain Visual Analog Scale

    Time frame: It is measured preoperatively and after the end of the operation at the 30th minute, 12th hour and 24th hour (up to 24 hours). Change from baseline Pain Visual Analog Scale scores at 24 hours.

    The Visual Pain Scale is a scale of ten centimeters, created to inquire about the pain status of individuals. Zero indicates no pain while ten indicates the most severe pain. This chart is prepared as a blank line for self-evaluation and the prepared chart is read on the ruler.

  2. Thermal Comfort Visual Analog Scale

    Time frame: It is measured before surgery and every half hour after surgery (up to 2 hours). The change in thermal comfort score before and within the first two hours after surgery is recorded.

    Horn et al. It is a visual assessment scale developed by. Thermal comfort is evaluated using a 100 mm long visual benchmark scale. Zero points represent the worst unbearable cold, 50 mm thermal comfort, 100 mm unbearable temperature. Objective responses of the patients were determined by making an evaluation from 0 to 100mm.

  3. Body Temperature Scale

    Time frame: It is measured before surgery and every fifteen minutes after surgery (up to 2 hours). The change in Body Temperature Scale score before and within the first two hours after surgery is recorded.

    It is the measurement chart prepared by the researcher. Includes measurement of body temperature over time.

Secondary outcomes

  1. Tremor Rating Scale

    Time frame: It is measured before and every 15 minutes after surgery (up to 1 hour). Changes in tremor from the first minute to an hour after surgery.

    Badjatia et al. it is a visual assessment scale developed by. The tremor intensity rating scale is a visual evaluation scale that is observed and evaluated by researchers. When the quality of the tremor is evaluated numerically; 0: no flickering; 1: tremor localized in the abdomen and neck; 2: tremors, including upper limbs; and 3: whole body tremors.

  2. Hemoglobin Parameters Scale

    Time frame: The hemoglobin level is measured before surgery and at 24th hours after surgery (up to 24 hours). Change from baseline hemoglobin level scores at 24 hours.

    Hemoglobin Parameters include leves at blood. Indicates the intraoperative bleeding level.

  3. International Normalized Ratio Parameters Scale

    Time frame: The Pt INR level is measured before surgery and at 1th hours after surgery (up to 1 hours). Change from preoperative Pt INR level at postoperative 1st hour.

    International Normalized Ratio Parameters include Pt INR leves at blood. Indicates the intraoperative bleeding risk of patients.

Sponsors and collaborators

Lead sponsor

Bozok University

Other

Collaborators

  • Ataturk University

Registry information

Official study title

The Effect of Different Warming Methods Applied to Patients for Prevention of Hypothermia on Pain, Comfort and Some Parameters in Laparoscopic Cholecystectomy Surgery

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Feb 5, 2021
Registry last updated
Mar 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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