- ICH GCP
- US-Register für klinische Studien
- Klinische Studie 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
Studienübersicht
Status
Bedingungen
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Geschätzt)
Kontakte und Standorte
Studienkontakt
- Name: Mahnoor Dr Wasim, MBBS, MRCSEd, CHPE
- Telefonnummer: +923075275080
- E-Mail: mahnoorwsm@gmail.com
Studieren Sie die Kontaktsicherung
- Name: Dr Zeeshan sarwar, MBBS, FCPS
- Telefonnummer: +923228420433
- E-Mail: mzeeshansarwar@gmail.com
Studienorte
-
-
Punjab Province
-
Lahore, Punjab Province, Pakistan, 54000
- Mayo Hospital Lahore
-
Kontakt:
- dr zeeshan sarwar, MBBS, FCPS
- Telefonnummer: +923075275080
- E-Mail: mzeeshansarwar@gmail.com
-
Kontakt:
- dr zeeshan sarwar, MBBS, FCPS
- E-Mail: mzeeshansarwar@gmail.com
-
Hauptermittler:
- Mahnoor dr Wasim, MBBS, MRCSEd, CHPE
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Kind
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Probenahmeverfahren
Studienpopulation
Beschreibung
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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
|---|
|
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.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Direct Postoperative Intensive Care Unit Admission
Zeitfenster: 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
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Association of Surgical Apgar Score category with direct postoperative ICU admission
Zeitfenster: 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
|
Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: dr zeeshan sarwar, King Edward Medical University
Publikationen und hilfreiche Links
Allgemeine Veröffentlichungen
- 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.
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Andere Studien-ID-Nummern
- 2023-7628
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Beschreibung des IPD-Plans
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .