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Comparison of LMA Proseal and LMA Supreme for Efficient Ventilation During Lateral Positioned Laparoscopic Surgeres

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ClinicalTrials.gov Identifier: NCT02852135
Recruitment Status : Completed
First Posted : August 2, 2016
Last Update Posted : March 9, 2017
Sponsor:
Information provided by (Responsible Party):
Sheng Lan, Changhai Hospital

Brief Summary:
The LMA Proseal and LMA Supreme are the third generation of LMA with potential advantages over the classic LMA.Several publications have reported the successful, safe use of Laryngeal Mask Airway devices in patients undergoing laparoscopic surgery. However, there have been no studies that have examined the application of LMA in patients during lateral positioned laparoscopic surgery. The aim of this study is to observe the safety and efficacy when LMA Proseal and LMA Supreme used in lateral positioned laparoscopic surgery under general anesthesia.

Condition or disease Intervention/treatment Phase
Urologic Surgical Procedures Device: LMA Proseal Device: LMA Supreme Not Applicable

Detailed Description:

We undertook a single-blind, parallel-group, randomized controlled trial.The patients were randomized to either LMA Proseal group or LMA Supreme group by computer generated allocation.

The patients were scheduled for elective lateral positioned laparoscopic surgery, such as laparoscopic radical nephrectomy, laparoscopic renal cyst decortication (LRCD) or laparoscopic adrenalectomy.Inclusion criteria for the patients were: Aged>18 years, ASA physical status grade I - Ⅲ and body mass index ≤30 kg.m-2. Exclusion criteria were: anticipated difficult airway (e.g., Modified Mallampati Class IV, oropharyngeal pathology), severe cardiopulmonary disease, increased risk of regurgitation and aspiration (e.g., gastro-esophageal reflux disease, and pregnant patients), and retroperitoneal laparoscopic procedures.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 186 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Health Services Research
Official Title: Comparison of LMA Proseal and LMA Supreme for Efficient Ventilation During Lateral Positioned Laparoscopic Surgeries
Study Start Date : July 2016
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Arm Intervention/treatment
Experimental: LMA Proseal group
The patients were randomly allocated to two groups by using computer-generated numbers.In LMA Prosealgroup,LMA Proseal was inserted into each patient after anesthesia induction.
Device: LMA Proseal
After preoxygenation, anaesthesia was induced with propofol, fentanyl and cisatracurium,LMA Proseal was inserted and cuff inflated in each group.

Experimental: LMA Supreme group
The patients were randomly allocated to two groups by using computer-generated numbers.In LMA Supreme group,LMA Supreme was inserted into each patient after anesthesia induction.
Device: LMA Supreme
After preoxygenation, anaesthesia was induced with propofol, fentanyl and cisatracurium ,LMA Supreme was inserted and cuff inflated in each group.




Primary Outcome Measures :
  1. oropharyngeal seal pressure between LMA Proseal group and LMA Supreme group [ Time Frame: intraoperative ]
    The equilibrating airway pressure was recorded when an audible leak occurred over the mouth.


Secondary Outcome Measures :
  1. Ventilatory efficiency scores for the LMAs [ Time Frame: intraoperative ]
  2. Adverse effects in two groups [ Time Frame: intraoperative ]
    The adverse effects including regurgitation,hypoxemia,dysphonia,blood stained after LMA removal, and postoperative sore throat.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The patients belong to ASA physical status grade I and Ⅲ, aged above 18 years and body weight less than 30 kg/m2,who underwent elective laparoscopic urology surgery in the lateral position.

Exclusion Criteria:

  • The patients with anticipated difficult airway (e.g., Modified Mallampati Class IV, oropharyngeal pathology), severe cardiopulmonary disease, increased risk of regurgitation and aspiration (e.g., gastro-esophageal reflux disease, and pregnant patients), and retroperitoneal laparoscopic procedures.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02852135


Sponsors and Collaborators
Changhai Hospital
Investigators
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Study Director: Liu Yi, D.M Department of Anesthesiology, Changhai Hospital Shanghai, Shanghai, China, 200433

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Responsible Party: Sheng Lan, Principal Investigator, Changhai Hospital
ClinicalTrials.gov Identifier: NCT02852135    
Other Study ID Numbers: LMA-lateral-laparoscopic
First Posted: August 2, 2016    Key Record Dates
Last Update Posted: March 9, 2017
Last Verified: March 2017
Keywords provided by Sheng Lan, Changhai Hospital:
Laryngeal Mask Airway
lateral position
laparoscopic surgery
Additional relevant MeSH terms:
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Chlorhexidine
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Anti-Infective Agents, Local
Anti-Infective Agents
Disinfectants