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A single-center, prospective, randomized, controlled trial comparing oropharyngeal leakage pressure in laparoscopic cholecystectomy with slipa-3G and LMA SupremeTM two-tube laryngeal mask Airway (LMA)

A single-center, prospective, randomized, controlled trial comparing oropharyngeal leakage pressure in laparoscopic cholecystectomy with slipa-3G and LMA SupremeTM two-tube laryngeal mask Airway (LMA)

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000038646
Enrollment
Unknown
Registered
2020-09-27
Start date
2020-09-27
Completion date
Unknown
Last updated
2020-12-14

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

Conditions

The gallbladder stones

Interventions

Group 1:Use Slipa-3g laryngeal mask
Group 2:Use LMA SupremeTM twin-tube Laryngeal mask

Sponsors

General Hospital of the PLA Northern Theater Command
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1) Patients undergoing laparoscopic cholecystectomy in the General Hospital of the Northern Theater Command; 2) Participate voluntarily and sign informed consent; 3) ASA I - III; 4) Aged 18 to 70 years, BMI<=30Kg/m; 5) CO2 pneumoperitoneal pressure <=12mmHg.

Exclusion criteria

Exclusion criteria: 1) The patient refuses or cannot give informed consent; 2) Pharynx infection or other pathological changes, such as oropharyngeal malformation, throat hematoma, abscess, etc. 3) Patients with reflux risk, such as hiatus hernia, obesity, pregnancy, and history of reflux; 4) Patients with laryngeal spasm, bronchospasm and laryngeal obstruction; 5) Full stomach, not fasting or water; 6) Patients with abdominal trauma, gastrointestinal bleeding and respiratory hemorrhage; 7) Patients with potential airway obstruction, such as trachea compression, trachea softening patients; 8) Patients with respiratory system infection or other pathological changes, such as pulmonary hypertension and COPD; 9) Allergic to latex products.

Design outcomes

Primary

MeasureTime frame
Oropharyngeal leakage pressure;

Secondary

MeasureTime frame
Mean arterial pressure;Heart rate;Pulse oxygen saturation;Bispectral index;Effective insertion time;Insert the number of times;Glottis view score;PCO2 at end of breath;Actual tidal volume;Peak airway pressure;

Countries

China

Contacts

Public ContactYugang Diao

General Hospital of the PLA Northern Theater Command

diao72@163.com+86 15309881160

Outcome results

None listed

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