Suspension of Mechanical Ventilation in Ureteroscopic Lithotripsy Under General Anesthesia
1 other identifier
interventional
150
1 country
1
Brief Summary
For some upper ureteral and renal stones,ureteroscopic lithotripsy needs to be performed under general anesthesia with interrupted suspension of mechanical ventilation, which could result in hypercapnia and hypoxia. In this study, the investigators hypothesize that 10 cmH2O PEEP added to the respiratory circuit with 1 L/min 100% oxygen might extend the time of ventilation suspension but have no effect on carbon dioxide retention in blood.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2013
Shorter than P25 for not_applicable
1 active site
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
April 1, 2013
CompletedFirst Submitted
Initial submission to the registry
April 2, 2013
CompletedFirst Posted
Study publicly available on registry
April 19, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2013
CompletedApril 19, 2013
April 1, 2013
5 months
April 2, 2013
April 11, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
change in blood gas
we chose different time points to mesure the changes in blood gas.
Baseline before suspension of ventilation, 5 min after suspension, 10 min after suspension, 15 min after suspension, 5 min after re-ventilaiton, 10 min after re-ventilation
Secondary Outcomes (1)
Change in systolic blood pressure
Baseline before suspension of ventilation, 5 min after suspension, 10 min after suspension, 15 min after suspension, 5 min after re-ventilaiton, 10 min after re-ventilation
Other Outcomes (3)
duration of the operation
from the start of the surgery to the end of the surgery
recovery time
from the end of anesthesia to return of consciousness
intraoperative awareness
from the initiation of anesthesia to the end of the surgery
Study Arms (2)
with PEEP
ACTIVE COMPARATOR10 cmH2O PEEP added to the respiratory curcuit during suspension of mechanical ventilation
without PEEP
PLACEBO COMPARATOR0 cmH2O PEEP added to the respiratory curcuit during suspension of mechanical ventilation
Interventions
PEEP means that when mechanical ventilation is suspended, the value of expiratory valve in the anesthesia machine is set at 10 cmH2O with 1 L/min 100% oxygen.
Eligibility Criteria
You may qualify if:
- ASA I\~III general anesthesia sign the informed consent
You may not qualify if:
- ASA IV or V woman who is pregnant or plans to bear
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Yi Zhou
Shanghai, Shanghai Municipality, 200433, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- NETWORK
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Department of Anesthesiology , Changhai Hospital Affiliated to Second Military Medical
Study Record Dates
First Submitted
April 2, 2013
First Posted
April 19, 2013
Study Start
April 1, 2013
Primary Completion
September 1, 2013
Study Completion
November 1, 2013
Last Updated
April 19, 2013
Record last verified: 2013-04