- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07640165
Gastric Ultrasound for Airway Management in Emergency Patients
8. juni 2026 opdateret af: Raden Besthadi Sukmono, Indonesia University
Airway Management Selection Based on Gastric Content and Residual Volume Assessment in Emergency Patients at RSCM: An Ultrasonography Study
This prospective observational cohort study evaluates the association between gastric residual content and volume, assessed by point-of-care gastric ultrasound (PoCUS), and the choice of airway management technique (Rapid Sequence Intubation vs. non Rapid Sequence Intubation) in adult emergency surgical patients at Rumah Sakit Cipto Mangunkusumo (RSCM).
Aspiration risk in emergency patients is a critical concern, and this study examines whether objective ultrasonographic findings change clinical decision-making compared to traditional clinical assessment alone.
Studieoversigt
Status
Afsluttet
Intervention / Behandling
Detaljeret beskrivelse
Emergency patients frequently have delayed gastric emptying, increasing aspiration risk during airway management.
Gastric PoCUS allows non-invasive, bedside assessment of gastric content (empty, liquid, solid, or mixed) and volume.
This study quantifies gastric antrum cross-sectional area (CSA) using the Perlas formula (GV = 27.0 + 14.6 × CSA - 1.28 × age) and reports whether USG findings influenced the anesthesiologist's plan (RSI or non-RSI).
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
43
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Jakarta Special Capital Region
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Jakarta, Jakarta Special Capital Region, Indonesien, 01430
- RSUPN Cipto Mangunkusumo
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
Adult emergency surgical patients (age >18 years) requiring airway management under general anesthesia at the Emergency Operating Room of RSUPN Dr. Cipto Mangunkusumo (RSCM), Jakarta, Indonesia.
The population includes both trauma (62.8%) and non-trauma (37.2%) emergency cases.
Patients were enrolled consecutively from July to August 2025.
Patients with conditions that could confound gastric ultrasound assessment or airway management decisions were excluded.
Beskrivelse
Inclusion Criteria:
- Emergency patients requiring airway management in the Emergency Operating Room
- Age >18 years
Exclusion Criteria:
- Pregnancy
- Morbid obesity (BMI >40 kg/m²)
- History of prior gastric or esophageal surgery
- Duodenal tube in situ
- Maxillofacial trauma or anticipated difficult airway
- Inability to adequately visualize the gastric antrum on ultrasound
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
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Emergency Surgical Patients
Adult emergency surgical patients (age >18 years) requiring airway management at the Emergency Operating Room of RSUPN Dr. Cipto Mangunkusumo (RSCM), who underwent preoperative gastric point-of-care ultrasound (PoCUS) to assess gastric content type and residual volume prior to anesthetic induction.
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Gastric antrum ultrasound performed using a low-frequency transducer (2-5 MHz; SonoSite M-Turbo or Lumify Philips) in the supine position before anesthetic induction.
The antrum cross-sectional area (CSA) was measured during the relaxation phase between two peristaltic contractions, calculating cranio-caudal (CC) and antero-posterior (AP) diameters.
Gastric residual volume (GRV) was calculated using the Perlas formula: GV = 27.0 + 14.6 × CSA - 1.28 × age (years).
Gastric content was classified as empty, liquid, solid, or mixed.
Aspiration risk was categorized as high (GRV ≥1.5 ml/kg or solid content) or low (GRV <1.5 ml/kg or empty).
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Association between aspiration risk based on gastric ultrasound findings and airway management technique selection
Tidsramme: At time of pre-induction assessment (single time point, intraoperative)
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Proportion of patients in whom airway management technique (Rapid Sequence Intubation vs. non Rapid Sequence Intubation) was associated with aspiration risk category (high vs. low) determined by preoperative gastric Point-of-Care Ultrasound (PoCUS) findings.
Aspiration risk classified as high if Gastric Residual Volume (GRV) ≥1.5 ml/kg or solid gastric content; low if GRV <1.5 ml/kg or empty stomach.
Analyzed using chi-square test.
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At time of pre-induction assessment (single time point, intraoperative)
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Change in Airway Management Plan After Gastric USG
Tidsramme: Before and immediately after gastric USG, prior to anesthetic induction
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Comparison of airway management plan (RSI vs. non-RSI) before and after disclosure of gastric USG findings to the treating anesthesiologist.
Analyzed using McNemar's paired categorical test.
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Before and immediately after gastric USG, prior to anesthetic induction
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Gastric Residual Volume
Tidsramme: At pre-induction assessment
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Gastric residual volume calculated using the Perlas formula: GV = 27.0 + 14.6 × CSA - 1.28 × age (years), based on antrum cross-sectional area (CSA) measured from cranio-caudal (CC) and antero-posterior (AP) diameters.
Reported as mean ± SD or median (range).
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At pre-induction assessment
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Gastric Content Type
Tidsramme: At pre-induction assessment
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Proportion of patients with each gastric content category: empty, liquid only, solid, or mixed (solid and liquid), as identified by gastric PoCUS.
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At pre-induction assessment
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Fasting Duration and Its Relationship to Gastric Residual Volume
Tidsramme: At pre-induction assessment
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Fasting duration categorized as <8 hours, 8-12 hours, or >12 hours since last solid food intake, and its relationship to gastric residual volume and aspiration risk classification on USG.
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At pre-induction assessment
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American Society of Anesthesiologists (ASA) Physical Status Classification as a factor in airway management decision
Tidsramme: At pre-induction assessment
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Proportion of patients in each American Society of Anesthesiologists (ASA) class (I, II, III, IV) and its association with airway management technique selection (RSI vs. non-RSI) after gastric USG, analyzed using chi-square test.
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At pre-induction assessment
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Trauma Severity Score (ISS) as a factor in airway management decision
Tidsramme: At pre-induction assessment
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Injury Severity Score (ISS) categorized as severe (ISS ≥15) or mild-moderate (ISS <15) and its association with airway management technique selection (RSI vs. non-RSI) after gastric USG, analyzed using chi-square test.
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At pre-induction assessment
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Glasgow Coma Scale (GCS) score as a factor in airway management decision
Tidsramme: At pre-induction assessment
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GCS score recorded at pre-induction assessment and its association with airway management technique selection (RSI vs. non-RSI) after gastric USG.
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At pre-induction assessment
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Presence of clinical risk factors (sepsis, shock, GERD/gastritis) as a factor in airway management decision
Tidsramme: At pre-induction assessment
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Proportion of patients with each clinical risk factor (sepsis, hemorrhagic shock, GERD/gastritis) and its association with airway management technique selection (RSI vs. non-RSI) after gastric USG, analyzed using chi-square or Fisher's exact test.
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At pre-induction assessment
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
5. juni 2025
Primær færdiggørelse (Faktiske)
13. august 2025
Studieafslutning (Faktiske)
13. september 2025
Datoer for studieregistrering
Først indsendt
2. juni 2026
Først indsendt, der opfyldte QC-kriterier
8. juni 2026
Først opslået (Faktiske)
10. juni 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
10. juni 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
8. juni 2026
Sidst verificeret
1. juni 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Patologiske processer
- Sygdomsegenskaber
- Luftvejssygdomme
- Sygdomme i fordøjelsessystemet
- Gastrointestinale sygdomme
- Respirationsforstyrrelser
- Esophageale sygdomme
- Esophageal Motilitetsforstyrrelser
- Deglutition lidelser
- Laryngopharyngeal refluks
- Gastroøsofageal refluks
- Respiratorisk aspiration
- Patologiske tilstande, tegn og symptomer
- Nødsituationer
- Respiratorisk aspiration af maveindhold
Andre undersøgelses-id-numre
- GastricUSG
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