NCT07640165

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 5, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 13, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 13, 2025

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

June 2, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 10, 2026

Completed
Last Updated

June 10, 2026

Status Verified

June 1, 2026

Enrollment Period

2 months

First QC Date

June 2, 2026

Last Update Submit

June 8, 2026

Conditions

Keywords

airway managementrapid sequence induction (RSI)gastric ultrasoundaspiration riskemergencypoint-of-care ultrasound (PoCUS)

Outcome Measures

Primary Outcomes (1)

  • Association between aspiration risk based on gastric ultrasound findings and airway management technique selection

    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)

Secondary Outcomes (8)

  • Change in Airway Management Plan After Gastric USG

    Before and immediately after gastric USG, prior to anesthetic induction

  • Gastric Residual Volume

    At pre-induction assessment

  • Gastric Content Type

    At pre-induction assessment

  • Fasting Duration and Its Relationship to Gastric Residual Volume

    At pre-induction assessment

  • American Society of Anesthesiologists (ASA) Physical Status Classification as a factor in airway management decision

    At pre-induction assessment

  • +3 more secondary outcomes

Study Arms (1)

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.

Device: Preoperative Gastric Point-of-Care Ultrasound (PoCUS)

Interventions

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).

Also known as: Gastric USG, Gastric Ultrasound, Bedside Gastric Sonography
Emergency Surgical Patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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.

You may qualify if:

  • Emergency patients requiring airway management in the Emergency Operating Room
  • Age \>18 years

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

RSUPN Cipto Mangunkusumo

Jakarta, Jakarta Special Capital Region, 01430, Indonesia

Location

MeSH Terms

Conditions

Respiratory Aspiration of Gastric ContentsEmergencies

Condition Hierarchy (Ancestors)

Laryngopharyngeal RefluxGastroesophageal RefluxEsophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesRespiratory AspirationRespiration DisordersRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsDisease Attributes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Anesthesiologist

Study Record Dates

First Submitted

June 2, 2026

First Posted

June 10, 2026

Study Start

June 5, 2025

Primary Completion

August 13, 2025

Study Completion

September 13, 2025

Last Updated

June 10, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations