NCT01343017

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Sep 2010

Shorter than P25 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2010

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

April 26, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 27, 2011

Completed
Last Updated

April 27, 2011

Status Verified

April 1, 2011

Enrollment Period

4 months

First QC Date

April 26, 2011

Last Update Submit

April 26, 2011

Conditions

Obesity

Keywords

AnaesthesiaPulmonary gas exchangeFunctional residual capacityCardiac outputSevoflurane

Outcome Measures

Primary Outcomes (1)

  • Increased tidal volumes impact on sevoflurane and oxygenation

    60 - 90 minutes

Secondary Outcomes (1)

  • Increased tidal volumes impact on cardiac output

    60 minutes

Study Arms (2)

Increased tidal volume (IVT)

OTHER

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

Normal tidal volume (NVT), with PEEP

OTHER

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

Interventions

Ventilatory patternOTHER

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.

Also known as: Increased tidal volume (IVT), Normal tidal volume with PEEP (NVT)
Increased tidal volume (IVT)Normal tidal volume (NVT), with PEEP

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ASA physical status 1 or 2
  • Scheduled for elective colon surgery
  • Body mass index more than 25 kg/m2

You may not qualify if:

  • Patients with known pulmonary or cardiovascular disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anaesthesia and Intensiv Care, Faculty of Medicine Lund University

Lund, Lund, SE-221 85, Sweden

Location

Related Publications (4)

  • Enekvist B, Bodelsson M, Sturesson LW, Johansson A. Larger tidal volume increases sevoflurane uptake in blood: a randomized clinical study. Acta Anaesthesiol Scand. 2010 Oct;54(9):1111-6. doi: 10.1111/j.1399-6576.2010.02291.x.

    PMID: 20887413BACKGROUND

  • Enekvist BJ, Luttropp HH, Johansson A. The effect of increased apparatus dead space and tidal volumes on carbon dioxide elimination and oxygen saturations in a low-flow anesthesia system. J Clin Anesth. 2008 May;20(3):170-4. doi: 10.1016/j.jclinane.2007.09.013.

    PMID: 18502358BACKGROUND

  • Luttropp HH, Johansson A. Soda lime temperatures during low-flow sevoflurane anaesthesia and differences in dead-space. Acta Anaesthesiol Scand. 2002 May;46(5):500-5. doi: 10.1034/j.1399-6576.2002.460505.x.

    PMID: 12027842BACKGROUND

  • Sturesson LW, Johansson A, Bodelsson M, Malmkvist G. Wash-in kinetics for sevoflurane using a disposable delivery system (AnaConDa) in cardiac surgery patients. Br J Anaesth. 2009 Apr;102(4):470-6. doi: 10.1093/bja/aep019. Epub 2009 Feb 25.

    PMID: 19244261BACKGROUND

MeSH Terms

Conditions

Obesity

Interventions

Positive-Pressure Respiration

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Respiration, ArtificialAirway ManagementTherapeuticsRespiratory Therapy

Study Officials

  • Mikael Bodelsson, Professor

    Department of Anaesthesia and Intensive Care, Faculty of Medicine, Lund University, Sweden

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
FACTORIAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 26, 2011

First Posted

April 27, 2011

Study Start

September 1, 2010

Primary Completion

January 1, 2011

Study Completion

April 1, 2011

Last Updated

April 27, 2011

Record last verified: 2011-04

Locations

SE(1)