- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07640165
Gastric Ultrasound for Airway Management in Emergency Patients
8 juni 2026 uppdaterad av: 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.
Studieöversikt
Status
Avslutad
Intervention / Behandling
Detaljerad beskrivning
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).
Studietyp
Observationell
Inskrivning (Faktisk)
43
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
Jakarta Special Capital Region
-
Jakarta, Jakarta Special Capital Region, Indonesien, 01430
- RSUPN Cipto Mangunkusumo
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Testmetod
Icke-sannolikhetsprov
Studera befolkning
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.
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
|---|---|
|
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.
|
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).
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Association between aspiration risk based on gastric ultrasound findings and airway management technique selection
Tidsram: At time of pre-induction assessment (single time point, intraoperative)
|
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.
|
At time of pre-induction assessment (single time point, intraoperative)
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in Airway Management Plan After Gastric USG
Tidsram: Before and immediately after gastric USG, prior to anesthetic induction
|
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.
|
Before and immediately after gastric USG, prior to anesthetic induction
|
|
Gastric Residual Volume
Tidsram: At pre-induction assessment
|
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).
|
At pre-induction assessment
|
|
Gastric Content Type
Tidsram: At pre-induction assessment
|
Proportion of patients with each gastric content category: empty, liquid only, solid, or mixed (solid and liquid), as identified by gastric PoCUS.
|
At pre-induction assessment
|
|
Fasting Duration and Its Relationship to Gastric Residual Volume
Tidsram: At pre-induction assessment
|
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.
|
At pre-induction assessment
|
|
American Society of Anesthesiologists (ASA) Physical Status Classification as a factor in airway management decision
Tidsram: At pre-induction assessment
|
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.
|
At pre-induction assessment
|
|
Trauma Severity Score (ISS) as a factor in airway management decision
Tidsram: At pre-induction assessment
|
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.
|
At pre-induction assessment
|
|
Glasgow Coma Scale (GCS) score as a factor in airway management decision
Tidsram: At pre-induction assessment
|
GCS score recorded at pre-induction assessment and its association with airway management technique selection (RSI vs. non-RSI) after gastric USG.
|
At pre-induction assessment
|
|
Presence of clinical risk factors (sepsis, shock, GERD/gastritis) as a factor in airway management decision
Tidsram: At pre-induction assessment
|
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.
|
At pre-induction assessment
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
5 juni 2025
Primärt slutförande (Faktisk)
13 augusti 2025
Avslutad studie (Faktisk)
13 september 2025
Studieregistreringsdatum
Först inskickad
2 juni 2026
Först inskickad som uppfyllde QC-kriterierna
8 juni 2026
Första postat (Faktisk)
10 juni 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
10 juni 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
8 juni 2026
Senast verifierad
1 juni 2026
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Patologiska processer
- Sjukdomsegenskaper
- Luftvägssjukdomar
- Matsmältningssystemets sjukdomar
- Gastrointestinala sjukdomar
- Andningsstörningar
- Esofagussjukdomar
- Esophageal motilitetsstörning
- Deglutition Disorders
- Laryngofaryngeal reflux
- Gastroesofageal reflux
- Andningsaspiration
- Patologiska tillstånd, tecken och symtom
- Nödsituationer
- Respiratorisk aspiration av maginnehåll
Andra studie-ID-nummer
- GastricUSG
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .