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PCV-VG Versus VCV Through the I-gel in Young Children

2026年11月4日 更新者:Kerollos Moneer Neseem Mikhael、Beni-Suef University

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

研究概览

详细说明

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.

研究类型

介入性

注册 (估计的)

90

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

学习地点

      • Banī Suwayf、埃及
        • Beni-Suef University Hospital

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

2年 至 7年 (孩子)

接受健康志愿者

不

有资格学习的性别

全部

描述

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

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:三倍

武器和干预

参与者组/臂
干预/治疗
实验性的: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.

其他名称:
  • PCV-VG
有源比较器: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.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Mean Expired Tidal Volume (VTe) Delivery Accuracy
大体时间:Measured at 20 minutes post-initiation of mechanical ventilation (T1) and at end of surgery / pre-emergence (T2, up to 120 minutes)

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)
Percentage of Participants With Ultrasonographically Confirmed Gastric Insufflation
大体时间:Intraoperative period (assessed at 20 minutes post-ventilation [T1] and end of surgery [T2], up to 120 minutes total)

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)

次要结果测量

结果测量
措施说明
大体时间
Mean Peak Inspiratory Pressure (Ppeak)
大体时间:Measured at 20 minutes post-initiation of mechanical ventilation (T1) and at end of surgery / pre-emergence (T2, up to 120 minutes)

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)
Mean Dynamic Respiratory System Compliance (Cdyn)
大体时间:Measured at 20 minutes post-initiation of mechanical ventilation (T1) and at end of surgery / pre-emergence (T2, up to 120 minutes)

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)
Mean Oropharyngeal Leak Pressure (OLP)
大体时间:Measured immediately post-i-gel placement (T0) and at 20 minutes post-initiation of mechanical ventilation (T1)

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)
Mean End-Tidal Carbon Dioxide (EtCO2) Concentration
大体时间: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)

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)
Percentage of Total Mechanical Ventilation Time With Hypercapnia (EtCO2 > 50 mmHg)
大体时间:Total duration of mechanical ventilation (up to 120 minutes)

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)
Percentage of Mechanical Breaths Exceeding Baseline Oropharyngeal Leak Pressure
大体时间:Entire duration of mechanical ventilation (up to 120 minutes)

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)
Percentage of Participants Experiencing Intraoperative Respiratory Adverse Events
大体时间:From i-gel insertion until PACU transfer (up to 180 minutes)

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)
i-gel Insertion Time
大体时间:At time of airway placement (induction period, approximately 1-3 minutes)

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)
Post-Anaesthesia Care Unit (PACU) Length of Stay
大体时间:Postoperative recovery period (up to 120 minutes)

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)
Percentage of Participants With Postoperative Airway Complications at 24 Hours
大体时间:24 hours postoperatively

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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年11月1日

初级完成 (估计的)

2027年4月1日

研究完成 (估计的)

2027年5月1日

研究注册日期

首次提交

2026年11月4日

首先提交符合 QC 标准的

2026年11月4日

首次发布 (实际的)

2026年11月10日

研究记录更新

最后更新发布 (实际的)

2026年11月10日

上次提交的符合 QC 标准的更新

2026年11月4日

最后验证

2026年11月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

是的

IPD 计划说明

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.

IPD 共享时间框架

Data will become available starting 6 months following primary journal publication and will remain accessible for up to 36 months post-publication.

IPD 共享访问标准

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.

IPD 共享支持信息类型

  • 研究方案
  • 树液

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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