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Active Warming During Elective Caesearean Section

Active Warming for Elective Caesarean Section - a RCT

During anaesthesia for caesarean section it is common to lose heat and become hypothermic, (<36 degrees C). In order to try and avoid this all women are given warmed intravenous fluid and insulated from cold surfaces. There are also 2 types of machine available to actively warm women;

  1. Forced Air Warming - that uses a disposable sheet the woman lies upon with lots of air pockets that have warm air blown into them continuously by a fan.
  2. Conduction Warming Mattress - a thin mattress which covers the operating table and the woman lies on top. The padded mattress has strips of material that heat up when electricity passes through it, similar to a normal electric blanket.

We plan to carry out a randomised controlled trial to compare these 2 methods with the current practice of no active warming.

The hypothesis for this study is that active warming women during elective caesarean section prevents women's temperature from dropping and keeps them more comfortable than if active warming were not used.

調査の概要

詳細な説明

When a baby is delivered by a surgical procedure (a caesarean section) the woman will usually have a "spinal" anaesthetic. With a "spinal", local anaesthetic is injected into the spinal fluid to make the woman numb from her chest to her feet, allowing her to be comfortable but awake during the birth. During this type of anaesthetic it is common to lose heat and become cold or "hypothermic" measured as less than 36 degrees Celsius. Becoming this cold can be uncomfortable for the woman but also causes other problems. It can make blood clotting less effective, alter the way wounds heal afterwards and make the woman more likely to develop infections or problems related to her heart and lungs.

To help keep their temperature stable, the investigators give all women fluid into the veins that is already warm and ensure that they are well insulated from any cold surfaces. There are two machines that the investigators can also use to actively warm patients but these are not yet used in every case. The first method is called "Forced Air Warming" and uses a special disposable sheet the woman lies upon with lots of air pockets that have warm air blown into them continuously by a fan. The woman is surrounded by these pockets of warm air, which help to warm her and also insulate against heat loss. The second method is called a "Conduction Warming Mattress" and uses a thin mattress which covers the operating table and the woman lies on top. The padded mattress has strips of material that heat up when electricity passes through it, similar to a normal electric blanket.

The investigators have already looked at the records of some women having caesarean sections in our hospital and found that both forced air warming and conduction mattress warming seem to help them stay warm. However, the investigators would like to study this in more detail and prove scientifically whether these methods are effective. Our aim in this study is to see if warming machines can help prevent women getting too cold, and prove scientifically whether one is more effective.

The hypothesis for this study is that active warming women during elective caesarean section prevents women's temperature from dropping and keeps them more comfortable than if active warming were not used.

The women will have exactly the same anaesthetic as they would have had if they were not in the study. If a woman agrees to be in the study she will be chosen randomly to receive either, normal care (including warmed fluids but no warming machines), additional warming with forced air or additional warming by conduction mattress. Her temperature will be measured at regular intervals before, during and after the caesarean section, at the same time she will be asked to score herself on a thermal comfort scale. The results will be analysed to compare the temperature changes in each group.

The investigators hope that the active warming machines will keep body temperature stable and prevent hypothermia. If the investigators find out that these machines prevent women getting cold, they can ensure that the most effective methods of warming during caesarean section operations are used and minimise problems due to becoming cold.

研究の種類

介入

入学 (実際)

130

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

    • South Yorkshire
      • Sheffield、South Yorkshire、イギリス、S10 2JF
        • Sheffield Teaching Hospitals NHS Trust

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

はい

受講資格のある性別

女性

説明

Inclusion Criteria:

  • Patients with a singleton, uncomplicated pregnancy, presenting for elective caesarean section under spinal anaesthesia, where surgery and anaesthesia are expected to be uncomplicated. Patients scheduled for tubal ligation surgery (sterilisation) as part of the caesarean section may also be included.

Exclusion Criteria:

  • Age under 18
  • BMI <19 or >30
  • Diseases of pregnancy: e.g. pregnancy induced hypertension
  • Grand Multiparity - ie parity of 5 or greater
  • Pre-operative pyrexia (temperature of 37.5 degrees C or greater)
  • Pre-operative hypothermia (temperature 36.0 degrees or cooler)
  • Significant co-existing maternal disease - e.g. congenital heart disease
  • Co-existing maternal disease that could impact on temperature- e.g. hypo/hyperthyroid
  • Coagulation abnormalities or anticipated excessive blood loss including any form of abnormal placentation
  • Surgical procedure expected not to be routine/deviation from normal practice
  • Condition preventing full, informed consent.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:防止
  • 割り当て:ランダム化
  • 介入モデル:並列代入
  • マスキング:ダブル

武器と介入

参加者グループ / アーム
介入・治療
介入なし:Normal care
Normal care - no active warming
アクティブコンパレータ:Forced air warming
Underbody forced air warming blanket
他の名前:
  • Underbody bairhugger
アクティブコンパレータ:Conduction warming mattress
Underbody conduction warming mattress
他の名前:
  • Inditherm conduction mattress

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Mean temperature on arrival in recovery
時間枠:Temperature will be measured on arrival in recovery.
The primary outcome of the study is to find whether there is a clinically significant statistical difference between the mean temperatures on arrival in recovery of the control and conduction mattress groups; the control and forced air warming groups; and the conduction mattress and forced air warming groups.
Temperature will be measured on arrival in recovery.

二次結果の測定

結果測定
メジャーの説明
時間枠
Peri-operative hypothermia
時間枠:Temperature will be measured evry 15 minutes throughout the duration of the procedure and in recovery room. The investigators anticipate that this will be over approximately a 2 hour period.
To find whether these active warming devices significantly reduce the incidence of peri-operative hypothermia during spinal anaesthesia for caesarean section
Temperature will be measured evry 15 minutes throughout the duration of the procedure and in recovery room. The investigators anticipate that this will be over approximately a 2 hour period.

その他の成果指標

結果測定
メジャーの説明
時間枠
Thermal comfort scores
時間枠:Thermal comfort will be assessed and scored at 15 minute intervals during surgery and in recovery. We anticipate that this will occur over approximately 2 hours.
To assess whether active warming makes patients too hot and assess maternal thermal comfort and satisfaction during active warming.
Thermal comfort will be assessed and scored at 15 minute intervals during surgery and in recovery. We anticipate that this will occur over approximately 2 hours.

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

捜査官

  • 主任研究者:Melanie J Woolnough, Mb ChB、Sheffield Teaching Hospitals NHS Foundation Trust

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始

2014年10月1日

一次修了 (実際)

2016年1月1日

研究の完了 (実際)

2016年1月1日

試験登録日

最初に提出

2014年7月15日

QC基準を満たした最初の提出物

2014年7月24日

最初の投稿 (見積もり)

2014年7月25日

学習記録の更新

投稿された最後の更新 (見積もり)

2016年10月13日

QC基準を満たした最後の更新が送信されました

2016年10月12日

最終確認日

2016年10月1日

詳しくは

本研究に関する用語

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

Forced air warmingの臨床試験

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