PCV-VG Versus VCV Through the I-gel in Young Children
PCV-VG Versus VCV for Ventilatory Efficacy and Gastric Safety Through the I-gel Supraglottic Airway in Young Children: A Randomized Controlled Trial
Supraglottic airway devices (SADs) like the i-gel are frequently used to manage airways during general anesthesia in children. However, delivering positive-pressure mechanical ventilation through a supraglottic airway carries a risk of gas leaking around the cuff into the stomach (gastric insufflation), which can cause stomach distension and increase the risk of regurgitation.
Volume-controlled ventilation (VCV) delivers a fixed breath volume, which can cause spikes in peak inspiratory pressure if airway resistance changes, potentially exceeding the device seal and forcing air into the stomach. Pressure-controlled ventilation with volume guarantee (PCV-VG) uses closed-loop feedback to auto-titrate inspiratory pressure breath-by-breath to target the desired tidal volume while minimizing peak airway pressures.
This prospective, single-center, randomized controlled trial aims to evaluate whether PCV-VG offers superior ventilatory efficacy (accurate tidal volume delivery) and enhanced gastric safety (lower incidence of ultrasonographically detected gastric insufflation) compared to VCV when using the i-gel supraglottic airway in children aged 2 to 7 years undergoing elective non-laparoscopic surgery
Panoramica dello studio
Stato
Stato
Condizioni
Condizioni
Intervento / Trattamento
Intervento / Trattamento
Descrizione dettagliata
Background and Rationale:
Controlled positive-pressure ventilation (PPV) via second-generation supraglottic airway devices (SADs) such as the i-gel is widely practiced in pediatric anesthesia. However, because SADs do not provide an absolute tracheal seal, peak inspiratory pressure (PIP) exceeding the individual oropharyngeal leak pressure (OLP) risks gas bypassing the cuff into the esophagus. Gastric insufflation increases intra-abdominal pressure, restricts diaphragmatic excursion, and elevates the risk of aspiration. Pressure-controlled ventilation with volume guarantee (PCV-VG) combines a decelerating flow profile with breath-by-breath feedback to deliver target tidal volume at the lowest feasible PIP. While studied in laparoscopic settings, prospective evidence evaluating PCV-VG versus VCV using serial radiologist-performed gastric antrum ultrasonography in non-laparoscopic pediatric surgery remains lacking.
Objectives:
To compare PCV-VG against VCV in children aged 2 to 7 years undergoing elective non-laparoscopic surgery with the i-gel across two co-primary domains:
Ventilatory efficacy: mean expired tidal volume (VTe) delivery relative to ideal body weight target.
Gastric safety: incidence of ultrasonographically confirmed gastric insufflation (antral cross-sectional area [CSA] increase ≥ 20% from baseline).
Trial Design & Interventions:
A prospective, single-center, parallel-group, double-blind, randomized superiority trial conducted at Beni-Suef University Hospital. Ninety children (2-7 years, weight 10-25 kg, ASA I-II) scheduled for elective non-laparoscopic procedures under general anesthesia with i-gel placement will be randomized 1:1 to:
Group PCV-VG (n = 45): Target VT 6-7 mL/kg IBW, PEEP 4 cmH2O, I:E 1:2, respiratory rate adjusted to EtCO2 35-45 mmHg, with closed-loop pressure adjustment capped at baseline OLP minus 3 cmH2O (absolute maximum 20 cmH2O).
Group VCV (n = 45): Target VT 6-7 mL/kg IBW with constant square inspiratory flow, identical PEEP, I:E, and RR targets, without active leak compensation.
Ultrasonic Evaluation Protocol:
A blinded consultant radiologist will perform serial sagittal gastric antrum ultrasonography at three defined timepoints:
T0: Immediately post-i-gel placement (baseline) T1: 20 minutes post-initiation of mechanical ventilation T2: End of surgery (pre-emergence) Antral cross-sectional area (CSA) will be calculated via the ellipse formula (π × D1 × D2 / 4). A positive gastric insufflation event is defined as a post-baseline CSA increase ≥ 20% confirmed on at least 2 of 3 measurements.
Tipo di studio
Tipo di studio
Iscrizione (Stimato)
Iscrizione
Fase
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
Contatto studio
- Nome: Kerollos Moneer Neseem Mikhael, MD
- Numero di telefono: 00201288549959
- Email: Kmnmk87@med.bsu.edu.eg
Luoghi di studio
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Banī Suwayf, Egitto
- Beni-Suef University Hospital
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Criteri di partecipazione
Criteri di ammissibilità
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Children aged 2 to 7 years inclusive
- Body weight 10 to 25 kg inclusive
- American Society of Anesthesiologists (ASA) physical status classification I or II
- Scheduled for elective non-laparoscopic surgical procedures of anticipated duration 30 to 120 minutes, not involving the airway, head, or neck (e.g., orthopedic, urological, perineal, or minor extremity procedures)
- Suitability for i-gel supraglottic airway management under controlled positive-pressure ventilation, as judged by the attending anesthesiologist
- Written informed consent obtained from a parent or legal guardian, and age-appropriate assent obtained from children aged ≥ 7 years
Exclusion Criteria:
- Anticipated or known difficult airway (history of failed supraglottic airway device insertion, syndromic anatomical airway anomalies, Mallampati class IV, or inter-incisor gap < 20 mm)
- Active upper or lower respiratory tract infection within 2 weeks prior to surgery
- Reactive airway disease (asthma or bronchiolitis) with active wheeze or exacerbation within 4 weeks
- Obesity: body mass index (BMI) ≥ 97th centile for age and sex according to WHO Child Growth Standards (2006)
- Gastro-esophageal reflux disease, symptomatic hiatus hernia, or any other condition conferring elevated pulmonary aspiration risk
- Congenital or acquired pulmonary disease (e.g., chronic lung disease of prematurity, cystic fibrosis, interstitial lung disease)
- Significant cardiovascular disease (ASA physical status ≥ III)
- Neuromuscular disease affecting respiratory mechanics
- Surgical procedure requiring prone, lateral decubitus, or head-down (Trendelenburg > 15°) positioning
- Emergency or semi-elective surgical cases
- Known allergy or documented contraindication to any anesthetic agent used in the protocol (propofol, sevoflurane, fentanyl, atracurium)
- Laparoscopic surgical procedure
- Enrollment in another interventional clinical trial within the preceding 30 days
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Triplicare
Numero di armi
Armi e interventi
Gruppo di partecipanti / ArmGruppo di partecipanti / Arm |
Intervento / TrattamentoIntervento / Trattamento |
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Sperimentale: Group PCV-VG (Pressure-Controlled Ventilation with Volume Guarantee)
Patients in this group will receive mechanical ventilation using Pressure-Controlled Ventilation with Volume Guarantee (PCV-VG; Draeger AutoFlow or platform equivalent) through an i-gel supraglottic airway device following standard intravenous induction and muscle relaxation with atracurium. Ventilation parameters: Target tidal volume (VT) set at 6-7 mL/kg ideal body weight (IBW), PEEP 4 cmH2O, I:E ratio 1:2, and age-stratified respiratory rate adjusted to maintain EtCO2 at 35-45 mmHg. The closed-loop algorithm dynamically auto-titrates inspiratory pressure (Pinsp) breath-by-breath based on the previous breath's expired tidal volume (VTe) to achieve target VT, with Pinsp safety ceiling capped at the individual baseline oropharyngeal leak pressure (OLP) minus 3 cmH2O (absolute maximum 20 cmH2O). |
Administration of closed-loop pressure-controlled ventilation with volume guarantee via the i-gel supraglottic airway, maintaining target VT 6-7 mL/kg IBW with breath-by-breath inspiratory pressure auto-titration.
Altri nomi:
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Comparatore attivo: Group VCV (Volume-Controlled Ventilation)
Patients in this group will receive standard mechanical ventilation using Volume-Controlled Ventilation (VCV) through an i-gel supraglottic airway device following standard intravenous induction and muscle relaxation with atracurium. Ventilation parameters: Set tidal volume (VT) programmed at 6-7 mL/kg ideal body weight (IBW) with a constant square inspiratory flow waveform, PEEP 4 cmH2O, I:E ratio 1:2, and age-stratified respiratory rate adjusted to maintain EtCO2 at 35-45 mmHg. No active closed-loop leak-compensation or pressure-guarantee algorithm is engaged. Peak inspiratory pressure safety limit is set at baseline OLP minus 3 cmH2O (absolute maximum 20 cmH2O). If VTe falls > 20% below set VT for ≥ 3 consecutive breaths, VT may be up-titrated in 0.5 mL/kg IBW increments up to maximum 9 mL/kg IBW provided peak pressure remains below OLP. |
Administration of traditional volume-controlled ventilation with constant inspiratory flow via the i-gel supraglottic airway, maintaining set VT 6-7 mL/kg IBW without automated pressure adaptation. |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Mean Expired Tidal Volume (VTe) Delivery Accuracy
Lasso di tempo: Measured at 20 minutes post-initiation of mechanical ventilation (T1) and at end of surgery / pre-emergence (T2, up to 120 minutes)
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Measured in milliliters per kilogram of ideal body weight (mL/kg IBW) using the anesthesia workstation flow sensor. Evaluates delivery accuracy relative to the prescribed target (6.0-7.0 mL/kg IBW). Values within the target prescribed range (6.0-7.0 mL/kg IBW) indicate a good result (effective alveolar ventilation). Values significantly below target (< 5.0 mL/kg IBW) indicate a bad result (hypoventilation due to circuit leak), while values above target (> 8.0 mL/kg IBW) indicate a bad result (risk of volutrauma). |
Measured at 20 minutes post-initiation of mechanical ventilation (T1) and at end of surgery / pre-emergence (T2, up to 120 minutes)
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Percentage of Participants With Ultrasonographically Confirmed Gastric Insufflation
Lasso di tempo: Intraoperative period (assessed at 20 minutes post-ventilation [T1] and end of surgery [T2], up to 120 minutes total)
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Defined as an increase in serial radiologist-measured gastric antrum cross-sectional area (CSA) ≥ 20% from baseline (T0), confirmed on ≥ 2 of 3 measurements at either T1 or T2, calculated using the ellipse formula: CSA=(π × D1 × D2)/4 A lower percentage indicates a good result (enhanced gastric safety and effective airway seal). A higher percentage indicates a bad result (increased risk of gastric distension, elevated intra-abdominal pressure, and pulmonary aspiration). |
Intraoperative period (assessed at 20 minutes post-ventilation [T1] and end of surgery [T2], up to 120 minutes total)
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Misure di risultato secondarie
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Mean Peak Inspiratory Pressure (Ppeak)
Lasso di tempo: Measured at 20 minutes post-initiation of mechanical ventilation (T1) and at end of surgery / pre-emergence (T2, up to 120 minutes)
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Peak airway pressure measured in centimeters of water (cmH2O) directly from the anesthesia workstation pressure transducer. A lower value indicates a good result (reduced risk of barotrauma and lower potential to exceed oropharyngeal leak pressure). A higher value indicates a bad result (increased pulmonary barotrauma risk and higher likelihood of driving gas into the esophagus). |
Measured at 20 minutes post-initiation of mechanical ventilation (T1) and at end of surgery / pre-emergence (T2, up to 120 minutes)
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Mean Dynamic Respiratory System Compliance (Cdyn)
Lasso di tempo: Measured at 20 minutes post-initiation of mechanical ventilation (T1) and at end of surgery / pre-emergence (T2, up to 120 minutes)
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Calculated using the formula: Cdyn= (VTe) ÷(Ppeak-PEEP), expressed in mL/cmH2O. A higher value indicates a good result (superior lung/thoracic compliance and lower resistance to inflation). A lower value indicates a bad result (stiffer lungs, higher airway resistance, or increased impedance). |
Measured at 20 minutes post-initiation of mechanical ventilation (T1) and at end of surgery / pre-emergence (T2, up to 120 minutes)
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Mean Oropharyngeal Leak Pressure (OLP)
Lasso di tempo: Measured immediately post-i-gel placement (T0) and at 20 minutes post-initiation of mechanical ventilation (T1)
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Airway pressure in cmH2O at which an anterior cervical leak is detected on precordial auscultation during circuit occlusion. A higher value indicates a good result (a tighter perilaryngeal device seal capable of sustaining higher positive pressure without leaking). A lower value indicates a bad result (poor device seal and higher risk of leak). |
Measured immediately post-i-gel placement (T0) and at 20 minutes post-initiation of mechanical ventilation (T1)
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Mean End-Tidal Carbon Dioxide (EtCO2) Concentration
Lasso di tempo: Measured at T0 (post-i-gel placement), T1 (20 minutes post-ventilation start), T2 (end of surgery), and at emergence / i-gel removal (up to 120 minutes)
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Measured in millimeters of mercury (mmHg) using continuous side-stream capnography on the anesthesia workstation to assess systemic ventilation status and carbon dioxide elimination. Directional Interpretation: Values within the physiological target range (35-45 mmHg) indicate a good result (optimal normocapnic ventilation). Values significantly above target (> 45 mmHg) indicate a bad result (hypercapnia/hypoventilation due to circuit leak or dead-space rebreathing), while values below target (< 30 mmHg) indicate a bad result (hypocapnia due to hyperventilation). |
Measured at T0 (post-i-gel placement), T1 (20 minutes post-ventilation start), T2 (end of surgery), and at emergence / i-gel removal (up to 120 minutes)
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Percentage of Total Mechanical Ventilation Time With Hypercapnia (EtCO2 > 50 mmHg)
Lasso di tempo: Total duration of mechanical ventilation (up to 120 minutes)
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Percentage calculated as: 100 × [(Duration of mechanical ventilation with EtCO2 > 50 mmHg)÷(Total Mechanical Ventilation Time)]. A lower percentage (ideally 0%) indicates a good result (effective carbon dioxide clearance throughout the surgical procedure). A higher percentage indicates a bad result (sustained alveolar hypoventilation or persistent leak leading to carbon dioxide retention). |
Total duration of mechanical ventilation (up to 120 minutes)
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Percentage of Mechanical Breaths Exceeding Baseline Oropharyngeal Leak Pressure
Lasso di tempo: Entire duration of mechanical ventilation (up to 120 minutes)
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Percentage calculated as: 100 × [(Breaths where Ppeak)> (Baseline OLP)÷ (Total Mechanical Breaths)]. A lower value (ideally 0%) indicates a good result (effective pressure containment within safe seal thresholds). A higher value indicates a bad result (frequent pressure spikes above the seal threshold, driving air into the stomach). |
Entire duration of mechanical ventilation (up to 120 minutes)
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Percentage of Participants Experiencing Intraoperative Respiratory Adverse Events
Lasso di tempo: From i-gel insertion until PACU transfer (up to 180 minutes)
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Composite incidence of laryngospasm, bronchospasm, oxygen desaturation (SpO2 < 93%), i-gel displacement, or endotracheal intubation conversion. A lower percentage indicates a good result (superior airway safety and stability). A higher percentage indicates a bad result (increased perioperative respiratory complications). |
From i-gel insertion until PACU transfer (up to 180 minutes)
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i-gel Insertion Time
Lasso di tempo: At time of airway placement (induction period, approximately 1-3 minutes)
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Time in seconds from first device handling until capnographic confirmation of airway placement. A lower value indicates a good result (faster, smoother airway securing). A higher value indicates a bad result (prolonged or difficult device placement). |
At time of airway placement (induction period, approximately 1-3 minutes)
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Post-Anaesthesia Care Unit (PACU) Length of Stay
Lasso di tempo: Postoperative recovery period (up to 120 minutes)
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PACU entry to achieving a modified Aldrete Score ≥ 9/10. A lower value indicates a good result (faster recovery and readiness for ward transfer). A higher value indicates a bad result (delayed recovery or lingering anesthetic effects). |
Postoperative recovery period (up to 120 minutes)
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Percentage of Participants With Postoperative Airway Complications at 24 Hours
Lasso di tempo: 24 hours postoperatively
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Composite incidence of sore throat, hoarseness, or dysphagia assessed at 24 hours via telephone. A lower percentage indicates a good result (minimal airway mucosal trauma). A higher percentage indicates a bad result (higher postoperative airway morbidity). |
24 hours postoperatively
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- FMBSUREC/08092026/ Mikhael
Piano per i dati dei singoli partecipanti (IPD)
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Descrizione del piano IPD
Anonymized individual participant data (including de-identified baseline demographic characteristics, primary and secondary outcome measure measurements, and ultrasonographic antral cross-sectional area calculations) will be made available to qualified academic researchers upon reasonable written request to the principal investigator, following publication of the primary trial results in a peer-reviewed journal.
Periodo di condivisione IPD
Data will become available starting 6 months following primary journal publication and will remain accessible for up to 36 months post-publication.
Criteri di accesso alla condivisione IPD
Data requests must be submitted directly to the Principal Investigator (Dr. Kerollos Moneer Neseem Mikhael) via Kmnmk87@med.bsu.edu.eg. Requesters must provide a scientifically sound research proposal and sign a formal Data Use Agreement (DUA). Data will be shared via secure cloud transfer.
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