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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01474850 |
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Date of registration:
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08/11/2011 |
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Primary sponsor: |
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Public title:
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Thoraco-abdominal Volume Variations During Recovery From Total Intravenous Anesthesia Studied by Opto-electronic Plethysmography
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Scientific title:
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Thoraco-abdominal Volume Variation During Recovery From Total Intravenous Anesthesia Studied by Opto-electronic Plethysmography. |
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Date of first enrolment:
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November 2011 |
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Target sample size:
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14 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01474850 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention
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Countries of recruitment
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Sweden
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Contacts
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Name:
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Peter Kostic, MD |
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Address:
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Telephone:
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+46186110000 |
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Email:
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peter.kostic@akademiska.se |
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Affiliation:
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Name:
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Peter Kostic |
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Address:
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Telephone:
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+46186110000 |
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Email:
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peter.kostic@akademiska.se |
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Affiliation:
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Name:
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Peter Frykholm |
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Address:
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Telephone:
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Email:
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Affiliation:
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Uppsala University Hospital |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- age > 18 years
- ASA classification I-II, scheduled for elective surgery requiring general anesthesia
- signed informed consent
Exclusion Criteria:
- BMI > 35
- co-existing respiratory disease (COPD, asthma )
- patient refusal
- pregnancy
- deformities of the thorax
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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General Anesthesia
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Intervention(s)
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Procedure: lung recruitment maneuver
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Procedure: No lung recruitment maneuver
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Primary Outcome(s)
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Opto-electronic plethysmography (OEP)
[Time Frame: 1. 5 min after each of these steps: the onset of the mechanical ventilation, the randomization, the end of the surgery 2. continuously during recovery 3. one hour after extubation]
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Secondary Outcome(s)
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Functional residual capacity (FRC)
[Time Frame: 5 min after each of these steps: the onset of mechanical ventilation, the randomization, the end of the sergery]
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Oxygenation (paO2)
[Time Frame: 5 min after each of these steps: the onset of mechanical ventilation, the randomization, the end of the surgery, extubation]
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Secondary ID(s)
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Uppsala 2011 - 190
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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