Comparison of Gastric Volume Changes After Ventilation With Endotracheal Tube, First-Generation Supraglottic Airway, and Second-Generation Supraglottic Airway in Pediatric Patients

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age1-10
SponsorIstanbul University

About this trial

This study aims to compare the gastric volumes of pediatric patients undergoing positive-pressure ventilation with different airway management techniques. Gastric ultrasound is a non-invasive bedside tool with high sensitivity and specificity for determining the nature and amount of gastric content. In pediatric cases, maintaining a gastric volume below 1.25 mL/kg is associated with a lower risk of perioperative aspiration.

Although supraglottic airway devices (SADs) are commonly used as alternatives to endotracheal tubes, concerns regarding the potential for gastric insufflation and subsequent aspiration persist. Second-generation SADs were specifically designed with gastric drainage channels to mitigate the risk of regurgitation compared to first-generation devices.

The primary objective of this study is to determine whether there is a difference in gastric volumes, as measured by ultrasound, among three groups of pediatric patients: those managed with endotracheal tubes, first-generation SADs, and second-generation SADs. By comparing these measurements post-ventilation, the investigators aim to evaluate the impact of the airway device choice on gastric volume under clinical conditions.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

1-10 years of age

Adherence to standard preoperative fasting guidelines

Elective surgeries

ASA I-III status

Disqualifiers

Gastrointestinal tract surgeries

Laparoscopic surgeries

Emergency procedures

Full stomach patients

Trial population

Pediatric patients (1-10 years) undergoing elective surgery

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

250 Participants
are grouped into 3 trial groups
Group A: Endotracheal intubation tube
Group B: First-generation supraglottic airway
Group C: Second-generation supraglottic airway

Trial outcomes

Primary outcomes

1

Comparison of gastric volume changes smong study groups

The primary outcome is to compare the change in gastric volume calculated via ultrasound at T0 (before induction), T1 (after the airway secured), and T2 (end of the operation) among the three groups (Endotracheal tube, first-generation SAD, and second-generation SAD). This will determine whether the choice of airway device leads to a difference in gastric volume during the perioperative period.

Time frame
up to 2 hours

Secondary outcomes

1

Correlation between duration of surgery and change in gastric volume

Total duration of the surgical procedure and the change in gastric volume

Time frame
30 minutes to 2 hours
2

Antral cross sectional area changes

Meauserement of antral cross sectional area at T0, T1 and T2 on lateral decubitis position

Time frame
up to 2 hours
3

Air leakege

Air leakage percentage with different airway devices

Time frame
up to 2 hours
4

Airway pressures

Peak airway pressures during surgery duration

Time frame
up to 2 hours

Other outcomes

Sponsors and contacts

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