Surgical Apgar Score for Identifying Patients Who May Need Intensive Care After Emergency Abdominal Surgery (SAS-ICU)
Surgical Apgar Score Predicts ICU Admission After Emergency General Surgery Laparotomy
調査の概要
状態
詳細な説明
Emergency general surgery laparotomy is associated with a substantial risk of postoperative complications and may require postoperative intensive care. In resource-limited healthcare settings, appropriate identification of patients who are likely to require intensive care may assist in postoperative triage and rational allocation of limited critical care resources.
The Surgical Apgar Score (SAS) is a simple 10-point perioperative risk score calculated using three intraoperative parameters: estimated blood loss, lowest mean arterial pressure, and lowest heart rate. Lower scores have been associated with increased postoperative morbidity and mortality in several surgical populations. Previous studies have also reported an association between low SAS and direct postoperative intensive care unit admission. However, evidence regarding its utility among patients undergoing emergency general surgery laparotomy in the local setting is limited.
This study will prospectively observe patients undergoing emergency exploratory laparotomy at Mayo Hospital Lahore and evaluate the relationship between the Surgical Apgar Score and direct postoperative intensive care unit admission. The score will be calculated immediately after surgery using routinely documented intraoperative parameters. Patients will subsequently be categorized according to their SAS, with scores of 7 or less classified as low and scores greater than 7 classified as high.
The study will determine the frequency of direct intensive care unit admission and assess whether patients with a low Surgical Apgar Score are more likely to require direct postoperative intensive care than those with a higher score. Relevant demographic and clinical characteristics will also be recorded to allow assessment of factors that may influence the relationship between SAS and intensive care admission.
The findings may help determine whether the Surgical Apgar Score can serve as a simple and readily available tool for identifying emergency laparotomy patients at increased risk of requiring postoperative intensive care. This may support more objective postoperative triage and resource allocation in high-volume, resource-constrained surgical settings.
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前:Mahnoor Dr Wasim, MBBS, MRCSEd, CHPE
- 電話番号:+923075275080
- メール:mahnoorwsm@gmail.com
研究連絡先のバックアップ
- 名前:Dr Zeeshan sarwar, MBBS, FCPS
- 電話番号:+923228420433
- メール:mzeeshansarwar@gmail.com
研究場所
-
-
Punjab Province
-
Lahore、Punjab Province、パキスタン、54000
- Mayo Hospital Lahore
-
コンタクト:
- dr zeeshan sarwar, MBBS, FCPS
- 電話番号:+923075275080
- メール:mzeeshansarwar@gmail.com
-
コンタクト:
- dr zeeshan sarwar, MBBS, FCPS
- メール:mzeeshansarwar@gmail.com
-
主任研究者:
- Mahnoor dr Wasim, MBBS, MRCSEd, CHPE
-
-
参加基準
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
健康ボランティアの受け入れ
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
- Male and female patients aged 13 to 89 years. Patients undergoing emergency exploratory laparotomy at Mayo Hospital Lahore for an emergency general surgery indication.
Patients undergoing laparotomy within 8 hours of surgical evaluation. Patients with emergency general surgery pathologies including gastrointestinal perforation, intestinal obstruction, ischemia, intra-abdominal sepsis, and blunt or penetrating abdominal trauma.
Patients who provide informed consent for participation.
Exclusion Criteria:
- Patients transferred from another emergency institution when more than 8 hours have elapsed since initial presentation.
Patients who do not undergo emergency exploratory laparotomy. Patients who do not have sufficient intraoperative data to calculate the Surgical Apgar Score.
Patients for whom postoperative disposition to ICU or another postoperative location cannot be determined.
研究計画
研究はどのように設計されていますか?
デザインの詳細
コホートと介入
グループ/コホート |
|---|
|
Low Surgical Apgar Score (≤7)
Participants undergoing emergency exploratory laparotomy who have a Surgical Apgar Score of ≤7, calculated immediately after surgery from estimated blood loss, lowest mean arterial pressure, and lowest heart rate recorded during the operation.
This cohort will be observed for direct admission to the intensive care unit following surgery.
No intervention is assigned as part of the study.
|
|
High Surgical Apgar Score (>7)
Participants undergoing emergency exploratory laparotomy who have a Surgical Apgar Score of >7, calculated immediately after surgery from estimated blood loss, lowest mean arterial pressure, and lowest heart rate recorded during the operation.
This cohort will be observed for direct admission to the intensive care unit following surgery.
No intervention is assigned as part of the study.
|
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 |
|---|---|---|
|
Direct Postoperative Intensive Care Unit Admission
時間枠:Within 1 hour after completion of surgery
|
The proportion of patients transferred directly from the operating room to the Intensive Care Unit immediately following emergency exploratory laparotomy.
|
Within 1 hour after completion of surgery
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Association of Surgical Apgar Score category with direct postoperative ICU admission
時間枠:Perioperative/Periprocedural
|
The proportion of patients with a low Surgical Apgar Score (≤7) will be compared with patients with a high Surgical Apgar Score (>7) to determine the association between SAS category and direct admission to the intensive care unit following emergency general surgery laparotomy.
|
Perioperative/Periprocedural
|
協力者と研究者
捜査官
- 主任研究者:dr zeeshan sarwar、King Edward Medical University
出版物と役立つリンク
一般刊行物
- Tracy BM, Srinivas S, Baselice H, Gelbard RB, Coleman JR. Surgical Apgar scores predict complications after emergency general surgery laparotomy. J Trauma Acute Care Surg. 2024 Mar 1;96(3):429-433. doi: 10.1097/TA.0000000000004189. Epub 2023 Nov 8.
- Lin YC, Chen YC, Yang CH, Su NY. Surgical Apgar score is strongly associated with postoperative ICU admission. Sci Rep. 2021 Jan 8;11(1):115. doi: 10.1038/s41598-020-80393-z.
- Gawande AA, Kwaan MR, Regenbogen SE, Lipsitz SA, Zinner MJ. An Apgar score for surgery. J Am Coll Surg. 2007 Feb;204(2):201-8. doi: 10.1016/j.jamcollsurg.2006.11.011. Epub 2006 Dec 27.
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- 2023-7628
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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。