Suspension of Mechanical Ventilation in Ureteroscopic Lithotripsy Under General Anesthesia

Hypoxia Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01835600
• Other study ID #: SMV-312
• Status: Not yet recruiting
• Phase: N/A
• First received: April 2, 2013
• Last updated: April 11, 2013
• Start date: April 2013
• Est. completion date: November 2013

Study information

• Verified date: April 2013
• Source: Chinese Medical Association
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: November 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Hypercapnia
• Hypoxia

Intervention

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.

Locations

Country	Name	City	State
China	Yi Zhou	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Chinese Medical Association

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	duration of the operation	We record the duration of the operation	from the start of the surgery to the end of the surgery	No
Other	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	Yes
Other	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	Yes
Primary	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	Yes
Secondary	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	Yes