Impact of Increased Tidal Volumes on Oxygenation and Cardiac Output
This study has been completed.
Sponsor:
Region Skane
Information provided by:
Region Skane
ClinicalTrials.gov Identifier:
NCT01343017
First received: April 26, 2011
Last updated: NA
Last verified: April 2011
History: No changes posted
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Purpose
General anaesthesia impairs respiratory function in overweight patients. The investigators wanted to compare arterial concentration of sevoflurane and oxygen in overweight patients ventilated with increased tidal volume, or normal tidal volume with added 10 cm H2O PEEP.
| Condition | Intervention |
|---|---|
|
Obesity |
Other: Ventilatory pattern |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Bio-equivalence Study Intervention Model: Factorial Assignment Masking: Single Blind (Subject) Primary Purpose: Supportive Care |
| Official Title: | Increased Tidal Volume During Anaesthesia Compared to PEEP. Impact on Arterial Concentration of Sevoflurane, Oxygenation and Cardiac Output in a Randomised Clinical Study of Overweight Patients. |
Resource links provided by NLM:
Further study details as provided by Region Skane:
Primary Outcome Measures:
- Increased tidal volumes impact on sevoflurane and oxygenation [ Time Frame: 60 - 90 minutes ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Increased tidal volumes impact on cardiac output [ Time Frame: 60 minutes ] [ Designated as safety issue: No ]
| Enrollment: | 30 |
| Study Start Date: | September 2010 |
| Study Completion Date: | April 2011 |
| Primary Completion Date: | January 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Increased tidal volume (IVT)
In the group with increased tidal volume (IVT), initial plateau pressure (Pplateau) will be monitored and then tidal volume will be increased until Pplateau was 0.04 cm H2O/kg over the initial Pplateau. The PETCO2 will be then adjusted to 4.5 kPa with a flexible corrugated hose placed between the Y-piece of the anaesthesia circle system and the heat and moisture filter (HME) attached to the endotracheal tube.
|
Other: Ventilatory pattern
In group one, increased tidal volume with a adjusted apparatus dead space volume (IVT), In group two, normal tidal volume with a PEEP to 10 cmH2O applied(NVT). PETCO2 will be adjusted to maintain at 4.5 kPa, in both groups. When PETCO2 values were stable at 4.5 kPa, sevoflurane administration will be started with a vaporiser set to 3%. After 5 minutes the fresh gas flow will be adjusted to 1.0 L/min with an unchanged vaporiser setting throughout the anaesthesia period.
Other Names:
|
|
Normal tidal volume (NVT), with PEEP
In the group with normal tidal volume (NVT), a PEEP to10 cmH2O will be applied. When required, VT will then adjusted to maintain PETCO2 at 4.5 kPa
|
Other: Ventilatory pattern
In group one, increased tidal volume with a adjusted apparatus dead space volume (IVT), In group two, normal tidal volume with a PEEP to 10 cmH2O applied(NVT). PETCO2 will be adjusted to maintain at 4.5 kPa, in both groups. When PETCO2 values were stable at 4.5 kPa, sevoflurane administration will be started with a vaporiser set to 3%. After 5 minutes the fresh gas flow will be adjusted to 1.0 L/min with an unchanged vaporiser setting throughout the anaesthesia period.
Other Names:
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Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- ASA physical status 1 or 2
- Scheduled for elective colon surgery
- Body mass index more than 25 kg/m2
Exclusion Criteria:
- Patients with known pulmonary or cardiovascular disease
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01343017
Locations
| Sweden | |
| Department of Anaesthesia and Intensiv Care, Faculty of Medicine Lund University | |
| Lund, Sweden, SE-221 85 | |
Sponsors and Collaborators
Region Skane
Investigators
| Study Chair: | Mikael Bodelsson, Professor | Department of Anaesthesia and Intensive Care, Faculty of Medicine, Lund University, Sweden |
More Information
Publications:
| Responsible Party: | Bengt Roth, M.D. , Ph.D., Head of Department, Department of Intensive and Perioperative Care, Lund University Hospital, SE-221 85 Lund, Sweden |
| ClinicalTrials.gov Identifier: | NCT01343017 History of Changes |
| Other Study ID Numbers: | Dnr 2009/533, EPN 2009/533 |
| Study First Received: | April 26, 2011 |
| Last Updated: | April 26, 2011 |
| Health Authority: | Sweden: The National Board of Health and Welfare |
Keywords provided by Region Skane:
|
Anaesthesia Pulmonary gas exchange Functional residual capacity Cardiac output Sevoflurane |
Additional relevant MeSH terms:
|
Obesity Overnutrition Nutrition Disorders Overweight Body Weight Signs and Symptoms Anesthetics Sevoflurane Central Nervous System Depressants |
Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Platelet Aggregation Inhibitors Hematologic Agents Anesthetics, Inhalation Anesthetics, General |
ClinicalTrials.gov processed this record on June 18, 2013