PCV-VG Versus VCV Through the I-gel in Young Children
NCT07928791, Not applicable, Not yet recruiting, Beni-Suef University
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | PCV-VG Versus VCV Through the I-gel in Young Children | ClinicalTrials.gov |
| NCT number | NCT07928791 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 90 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Beni-Suef University | ClinicalTrials.gov |
| Conditions | General Aneshesia, Intraoperative Complications, Gastric Insufflation, Airway Management | ClinicalTrials.gov |
| Interventions | Pressure-Controlled Ventilation with Volume Guarantee (PCV-VG), Volume-Controlled Ventilation (VCV) | ClinicalTrials.gov |
| First posted | 2026-11-10 | ClinicalTrials.gov |
| Last updated | 2026-11-10 | ClinicalTrials.gov |
Registered outcomes 12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Mean Expired Tidal Volume (VTe) Delivery Accuracy | 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). | ClinicalTrials.gov |
| Primary | Percentage of Participants With Ultrasonographically Confirmed Gastric Insufflation | 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). | ClinicalTrials.gov |
| Secondary | Mean Peak Inspiratory Pressure (Ppeak) | 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). | ClinicalTrials.gov |
| Secondary | Mean Dynamic Respiratory System Compliance (Cdyn) | 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). | ClinicalTrials.gov |
| Secondary | Mean Oropharyngeal Leak Pressure (OLP) | 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). | ClinicalTrials.gov |
| Secondary | Mean End-Tidal Carbon Dioxide (EtCO2) Concentration | 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). | ClinicalTrials.gov |
| Secondary | Percentage of Total Mechanical Ventilation Time With Hypercapnia (EtCO2 > 50 mmHg) | 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). | ClinicalTrials.gov |
| Secondary | Percentage of Mechanical Breaths Exceeding Baseline Oropharyngeal Leak Pressure | 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). | ClinicalTrials.gov |
| Secondary | Percentage of Participants Experiencing Intraoperative Respiratory Adverse Events | 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). | ClinicalTrials.gov |
| Secondary | i-gel Insertion Time | 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). | ClinicalTrials.gov |
| Secondary | Post-Anaesthesia Care Unit (PACU) Length of Stay | 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). | ClinicalTrials.gov |
| Secondary | Percentage of Participants With Postoperative Airway Complications at 24 Hours | 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). | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)