Back to resultsSuspension of Mechanical Ventilation in Ureteroscopic Lithotripsy Under General Anesthesia
Primary Purpose
Hypercapnia, Hypoxia
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
PEEP
Sponsored by
About this trial
This is an interventional supportive care trial for Hypercapnia
Eligibility Criteria
Inclusion Criteria:
ASA I~III general anesthesia sign the informed consent
Exclusion Criteria:
ASA IV or V woman who is pregnant or plans to bear
Sites / Locations
- Yi Zhou
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
with PEEP
without PEEP
Arm Description
10 cmH2O PEEP added to the respiratory curcuit during suspension of mechanical ventilation
0 cmH2O PEEP added to the respiratory curcuit during suspension of mechanical ventilation
Outcomes
Primary Outcome Measures
change in blood gas
we chose different time points to mesure the changes in blood gas.
Secondary Outcome Measures
Change in systolic blood pressure
we chose different time points to mesure the changes in systolic blood pressure
Full Information
NCT ID
NCT01835600
First Posted
April 2, 2013
Last Updated
April 11, 2013
Sponsor
Chinese Medical Association
1. Study Identification
Unique Protocol Identification Number
NCT01835600
Brief Title
Suspension of Mechanical Ventilation in Ureteroscopic Lithotripsy Under General Anesthesia
Study Type
Interventional
2. Study Status
Record Verification Date
April 2013
Overall Recruitment Status
Unknown status
Study Start Date
April 2013 (undefined)
Primary Completion Date
September 2013 (Anticipated)
Study Completion Date
November 2013 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese Medical Association
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
For some upper ureteral and renal stones,ureteroscopic lithotripsy is often perdurbed by the patient's respiratory movement either under epidural anesthesia or general anesthesia with mechanical ventilation. So intermittent suspension of mechanical ventilation under general anesthesia can ensure the surgery to be performed continuously and successfully. But this could result in hypercapnia and hypoxia. So far, there have been few studies focused on the change of the internal environment in blood as result of suspending breath. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercapnia, Hypoxia
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
with PEEP
Arm Type
Active Comparator
Arm Description
10 cmH2O PEEP added to the respiratory curcuit during suspension of mechanical ventilation
Arm Title
without PEEP
Arm Type
Placebo Comparator
Arm Description
0 cmH2O PEEP added to the respiratory curcuit during suspension of mechanical ventilation
Intervention Type
Other
Intervention Name(s)
PEEP
Other Intervention Name(s)
positive end-expiratory pressure
Intervention Description
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.
Primary Outcome Measure Information:
Title
change in blood gas
Description
we chose different time points to mesure the changes in blood gas.
Time Frame
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 Outcome Measure Information:
Title
Change in systolic blood pressure
Description
we chose different time points to mesure the changes in systolic blood pressure
Time Frame
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 Pre-specified Outcome Measures:
Title
duration of the operation
Description
We record the duration of the operation
Time Frame
from the start of the surgery to the end of the surgery
Title
recovery time
Description
We record how long it will take for the patients to act accoreding to our order after ceasing anesthesia.
Time Frame
from the end of anesthesia to return of consciousness
Title
intraoperative awareness
Description
We will record if patinets have any memory during the operative, namely intraoperatiove awareness.
Time Frame
from the initiation of anesthesia to the end of the surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
ASA I~III general anesthesia sign the informed consent
Exclusion Criteria:
ASA IV or V woman who is pregnant or plans to bear
Facility Information:
Facility Name
Yi Zhou
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200433
Country
China
12. IPD Sharing Statement
Learn more about this trial
Suspension of Mechanical Ventilation in Ureteroscopic Lithotripsy Under General Anesthesia
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