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The effect of three ventilation modes on gastric inflation during laparoscopic cholecystectomy in adults evaluated by ultrasound during anesthesia induction —— A randomized, double-blind, controlled trial

The effect of three ventilation modes on gastric inflation during laparoscopic cholecystectomy in adults evaluated by ultrasound during anesthesia induction —— A randomized, double-blind, controlled trial

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400082778
Enrollment
Unknown
Registered
2024-04-08
Start date
2024-04-08
Completion date
Unknown
Last updated
2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients undergoing laparoscopic cholecystectomy

Interventions

Capacity Control Group:Mask ventilation in volume-controlled mode
Pressure Control Group:Mask ventilation in pressure-controlled mode
Pressure Regulating Capacity Control Group:Mask ventilation using pressure-regulated volume control mode

Sponsors

The First Affiliated Hospital of Shantou University Medical College
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 68 Years

Inclusion criteria

Inclusion criteria: ? Patients undergoing elective laparoscopic cholecystectomy under general anesthesia with tracheal intubation; ? ASA level I-III; ? Age 18-68 years old; ? 18kg/? = Body Mass Index (BMI) = 28kg/?; ? Patients with non preoperative indwelling gastric tubes;

Exclusion criteria

Exclusion criteria: ? Stomach fullness (fasting for less than 8 hours, fasting for less than 2 hours); ? Oxygen saturation before induction<92%; ? Pregnancy or large abdominal mass; ? Diagnose patients with gastroesophageal reflux disease; ? History of gastroesophageal surgery; ? Pyloric obstruction or high intestinal obstruction disease; ? Severe respiratory and circulatory system diseases, such as severe coronary heart disease, chronic obstructive pulmonary disease, etc.; ? Preoperative mental illness or language dysfunction that prevents communication; ? Patients with mask dyspnea (DMV): Modified Mallampati classification of 3-4 levels, diagnosis of obstructive sleep apnea syndrome, craniofacial abnormalities, cervical instability and limited retroversion, mandibular recession, edentulism or whiskers; ? Awake intubation is required; ? Patients with nasal congestion, rhinitis, abnormal nasal and pharyngeal anatomy, and patients after nasal and pharyngeal surgery; ? Patients with hyperthyroidism or hypothyroidism; ? Refuse to enroll patients.

Design outcomes

Primary

MeasureTime frame
Percentage difference (rate of change) in gastric antral CSA measured by ultrasound before induction and after mask ventilation;

Secondary

MeasureTime frame
CSA variation difference;Positive rate of gastric blowing during mask ventilation;Classification of gastric inflation degree under laparoscopy;Respiratory parameters: ETCO2, inspiratory tidal volume, expiratory tidal volume, peak airway pressure, etc;Vital signs: non-invasive blood pressure, heart rate, SPO2;The incidence of aspiration during direct intubation and extubation;The degree of upper abdominal distension, nausea and vomiting, as well as the incidence of reflux and hiccup, during wakefulness after extubation and 48 hours after surgery;

Countries

China

Contacts

Public ContactZeng Zhaodong

Department of Anesthesiology, The First Affiliated Hospital of Shantou University Medical College

zzd700@163.com+86 131 1256 8837

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026