NCT02539485

Brief Summary

The effect of heating precondition of streamlined liner of the pharynx airway (SLIPA) on respiratory mechanics and sore throat was investigated.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

August 28, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 3, 2015

Completed
Last Updated

September 3, 2015

Status Verified

August 1, 2015

Enrollment Period

2 months

First QC Date

August 28, 2015

Last Update Submit

September 1, 2015

Conditions

Complication of Artificial Airway

Outcome Measures

Primary Outcomes (2)

  • Oropharyngeal leak pressure

    5 minutes

  • postoperative sore throat

    60 minutes

Study Arms (1)

heating precondition

OTHER

The mean maximum sealing pressure, gas leakage, gastric distension, postoperative sore throat and other complication were compared between heating precondition group and control group.

Other: heating precondition

Interventions

heating preconditionOTHER

The streamlined liner of the pharynx airway (SLIPA) was heated 2 hours before use.

heating precondition

Eligibility Criteria

Age18 Years - 60 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Hysteroscopic surgery
  • General anesthesia

You may not qualify if:

  • Upper respiratory disease
  • Communication disfunction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Obstetric & Gynecology Hospital

Shanghai, Shanghai Municipality, 200090, China

RECRUITING

Related Publications (1)

  • Geng G, Chen Y, Liu H. Preheating of streamlined liner of pharyngeal airway (SLIPA) reduced the related complications: a randomized control study. J Clin Monit Comput. 2017 Jun;31(3):547-550. doi: 10.1007/s10877-016-9875-z. Epub 2016 Apr 8.

    PMID: 27059218DERIVED

Study Officials

  • Guiqi Geng, PhD

    obstetric & gynecology hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Guiqi mi Geng, PhD

CONTACT

86 21 33189900mzgengguiqi@163.com

Shaoqiang Huang, MD

CONTACT

86 21 33189900redhouseliangxin@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

August 28, 2015

First Posted

September 3, 2015

Study Start

June 1, 2015

Primary Completion

August 1, 2015

Last Updated

September 3, 2015

Record last verified: 2015-08

Locations

CN(1)