Suspension of Mechanical Ventilation in Ureteroscopic Lithotripsy Under General Anesthesia

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.

Study Overview

• Status: Unknown
• Conditions: Hypoxia; Hypercapnia
• Intervention / Treatment: Other: PEEP

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 Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200433
      • Yi Zhou

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in systolic blood pressure	we chose different time points to mesure the changes 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
duration of the operation	We record the duration of the operation	from the start of the surgery to the end of the surgery
recovery time	We record how long it will take for the patients to act accoreding to our order after ceasing anesthesia.	from the end of anesthesia to return of consciousness
intraoperative awareness	We will record if patinets have any memory during the operative, namely intraoperatiove awareness.	from the initiation of anesthesia to the end of the surgery

Collaborators and Investigators

• Sponsor: Chinese Medical Association

Study record dates

Study Major Dates

• Study Start: April 1, 2013
• Primary Completion (ANTICIPATED): September 1, 2013
• Study Completion (ANTICIPATED): November 1, 2013

Study Registration Dates

• First Submitted: April 2, 2013
• First Submitted That Met QC Criteria: April 11, 2013
• First Posted (ESTIMATE): April 19, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): April 19, 2013
• Last Update Submitted That Met QC Criteria: April 11, 2013
• Last Verified: April 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Respiratory; Hypoxia; Hypercapnia
• Other Study ID Numbers: SMV-312