- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07814131
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
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Anslået)
Kontakter og lokationer
Studiekontakt
- Navn: Mahnoor Dr Wasim, MBBS, MRCSEd, CHPE
- Telefonnummer: +923075275080
- E-mail: mahnoorwsm@gmail.com
Undersøgelse Kontakt Backup
- Navn: Dr Zeeshan sarwar, MBBS, FCPS
- Telefonnummer: +923228420433
- E-mail: mzeeshansarwar@gmail.com
Studiesteder
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Punjab Province
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Lahore, Punjab Province, Pakistan, 54000
- Mayo Hospital Lahore
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Kontakt:
- dr zeeshan sarwar, MBBS, FCPS
- Telefonnummer: +923075275080
- E-mail: mzeeshansarwar@gmail.com
-
Kontakt:
- dr zeeshan sarwar, MBBS, FCPS
- E-mail: mzeeshansarwar@gmail.com
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Ledende efterforsker:
- Mahnoor dr Wasim, MBBS, MRCSEd, CHPE
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
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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.
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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.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Direct Postoperative Intensive Care Unit Admission
Tidsramme: Within 1 hour after completion of surgery
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The proportion of patients transferred directly from the operating room to the Intensive Care Unit immediately following emergency exploratory laparotomy.
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Within 1 hour after completion of surgery
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Association of Surgical Apgar Score category with direct postoperative ICU admission
Tidsramme: Perioperative/Periprocedural
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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.
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Perioperative/Periprocedural
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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: dr zeeshan sarwar, King Edward Medical University
Publikationer og nyttige links
Generelle publikationer
- 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.
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- 2023-7628
Plan for individuelle deltagerdata (IPD)
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