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Completed

NCT Number: NCT05302323

Evaluation of the Effect of Surgical Drapes on Intraoperative Hypothermia

This study was planned to investigate whether the wetness of surgical drapes (disposable and resusable drapes) used in the intraoperative period causes hypothermia.

Completed

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Key information

Age range

18 year–69 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gulhane training and research hospital

Ankara, Keçiören, 06010, Turkey (Türkiye)

About this study

After being informed about the study and potential risk all patients giving written informed consent then the study started. Patients who will undergo elective, gastrointestinal and other major abdominal surgery were included in the study. After patients were randomized by the investigator, patients were covered with disposable or reusable surgical drapes in accordance with hospital procedure. The body temperatures of the patients were followed for 2-6 hours as tympanic and esophageal. In addition, pre- and postoperative surgical drapes, sponges, compresses were measured with precision scales.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • ASA 1-2-3
  • Patients with abdominal surgery
  • Patients receiving general anesthesia

Exclusion criteria

  • Unwanted to participate in the study
  • Patients over 70 years of age
  • Presence of central (high) fever originating from the central nervous system resulting from conditions such as cerebrovascular disease, cerebral trauma, intracranial surgery, epilepsy or acute hydrocephalus
  • Abnormalities of thermoregulation such as hypothyroidism, hyperthyroidism, history of malignant hyperthermia, or neuroleptic malignant syndrome
  • Presence of infectious fever
  • ASA 4 and above
  • Emergency surgery
  • Patients receiving pre-operative chemotherapy
  • Having problems such as tearing and perforation of the covers during the work.
  • Patients being hyperthermic in the intraoperative process

Treatment and study plan

Disposable Drape

Other

Disposable surgical drapes, consisting of 6 pieces, were used as a set during surgery

Reusable Drape

Other

Reusable surgical drapes, consisting of 6 pieces, were used as a set during surgery

Primary outcomes

  1. tympanic and esophageal body temperature measurement between two groups

    Time frame: throughout the operation (min.2 hours) (max. 6 hours)

    Tympanic and esophageal body temperature measurement between the two groups was followed throughout the operation.

Sponsors and collaborators

Lead sponsor

Neslihan Ilkaz

Other

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2021
First posted
Mar 31, 2022
Registry last updated
Apr 14, 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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