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Airway Peak Pressure-directed Laryngeal Mask Airway Intracuff Pressure Setting

A Clinical Study of the Setting of Laryngeal Mask Airway Intracuff Pressure Based on Airway Peak Pressure

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03365557
Enrollment
120
Registered
2017-12-07
Start date
2016-10-01
Completion date
2018-04-30
Last updated
2020-03-18

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

Conditions

Laryngeal Mask Airway

Brief summary

The investigators aimed to explore the effects of airway peak pressure (Ppeak) guidance on the least laryngeal mask airway (LMA) intracuff pressure setting during general anesthesia and the effects on postoperative complications in the throat. One hundred and twenty patients (American Society of Anesthesiologists grades I or II) scheduled for elective laparoscopic cholecystectomy under general anesthesia were enrolled in our study. The patients were divided into pressure-regulated group (group P) and control group (group C) randomly. Supreme LMA was inserted in after general anesthesia induction. Air was injected into the cuff to make the intracuff pressure (ICP) achieve 60 cmH2O. Volume-controlled ventilation was selected and Ppeak was recorded. In group P, all the gas in the LMA cuff was sucked out, and then air was injected in during expiration phase to make ICP achieve the level of Ppeak. If there's any leakage, increase 5 cmH2O every time till there's no air leakage from the mouth. After pneumoperitoneum, the cuff was inflated to make ICP achieve 60 cmH2O and Ppeak was recorded once more. Then all the gas in the LMA cuff was sucked out, and air was injected into the cuff during expiration phase to make ICP achieve the level of Ppeak as the above method till the end of operation. During pneumoperitoneum, the pressure of CO2 was set at 10 cmH2O. In group C, ICP was maintained at 60 cmH2O. Ppeak, ICP and the intracuff gas volume were recorded before and after pneumoperitoneum. ICP during inspiratory phase in the two groups was measured. Tidal volume during inspiration (VTI) and expiration (VTE) in the two groups were recorded, and the leakage rate was calculated as \[(VTI-VTE)/ VTI×100%\]. Throat complications of all the patients in 24 hours after surgeries were also recorded.

Interventions

PROCEDUREAirway peak pressure

Air was injected into LMA cuff during expiration phase to make intracuff pressure achieve the level of airway peak pressure. If there's any leakage, increase 5 cmH2O every time till there's no air leakage from the mouth.

Sponsors

Yangzhou University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* Patients with American Society of Anesthesiologists grades I or II scheduled for elective laparoscopic cholecystectomy under general anesthesia

Exclusion criteria

* Patients with limited head and neck activity, limited mouth opening, high abdominal pressure, inflammation of the throat and respiratory diseases

Design outcomes

Primary

MeasureTime frameDescription
The intracuff pressure after pneumoperitoneumIntraoperativeThe changes of intracuff pressure after pneumoperitoneum
The intracuff gas volume before pneumoperitoneumIntraoperativeThe changes of intracuff gas volume before pneumoperitoneum
The intracuff gas volume after pneumoperitoneumIntraoperativeThe changes of intracuff gas volume after pneumoperitoneum
The intracuff pressure before pneumoperitoneumIntraoperativeThe changes of intracuff pressure before pneumoperitoneum

Secondary

MeasureTime frameDescription
Throat complicationsFrom the end of operation till 24 hs postoperativeThroat pain, swallow discomfort and hematoma

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026