Impact of Increased Tidal Volumes on Oxygenation and Cardiac Output

This study has been completed.
Sponsor:
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
  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:
  • Increased tidal volume (IVT)
  • Normal tidal volume with PEEP (NVT)
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:
  • Increased tidal volume (IVT)
  • Normal tidal volume with PEEP (NVT)

  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
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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 July 29, 2014