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Suspension of Mechanical Ventilation in Ureteroscopic Lithotripsy Under General Anesthesia

Sponsor
Chinese Medical Association (Other)
Overall Status
Unknown status
CT.gov ID
NCT01835600
Collaborator
(none)
150
Enrollment
1
Location
2
Arms
7
Duration (Months)
21.3
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: PEEP
 N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
150 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Supportive Care
Study Start Date :
Apr 1, 2013
Anticipated Primary Completion Date :
Sep 1, 2013
Anticipated Study Completion Date :
Nov 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: with PEEP

10 cmH2O PEEP added to the respiratory curcuit during suspension of mechanical ventilation

Other: PEEP
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.
Other Names:
  • positive end-expiratory pressure

    		•
    Placebo Comparator: without PEEP

    0 cmH2O PEEP added to the respiratory curcuit during suspension of mechanical ventilation

    Outcome Measures

    Primary Outcome Measures

    1. change 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]

      we chose different time points to mesure the changes in blood gas.

    Secondary Outcome Measures

    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]

      we chose different time points to mesure the changes in systolic blood pressure

    Other Outcome Measures

    1. duration of the operation [from the start of the surgery to the end of the surgery]

      We record the duration of the operation

    2. recovery time [from the end of anesthesia to return of consciousness]

      We record how long it will take for the patients to act accoreding to our order after ceasing anesthesia.

    3. intraoperative awareness [from the initiation of anesthesia to the end of the surgery]

      We will record if patinets have any memory during the operative, namely intraoperatiove awareness.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Yi Zhou Shanghai Shanghai China 200433

    Sponsors and Collaborators

    • Chinese Medical Association

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Yi Zhou, Department of Anesthesiology , Changhai Hospital Affiliated to Second Military Medical, Chinese Medical Association
    ClinicalTrials.gov Identifier:
    NCT01835600
    Other Study ID Numbers:
    • SMV-312
    First Posted:
    Apr 19, 2013
    Last Update Posted:
    Apr 19, 2013
    Last Verified:
    Apr 1, 2013
    Additional relevant MeSH terms:
    Hypoxia
    Hypercapnia

    Study Results

    No Results Posted as of Apr 19, 2013