NCT01683578

Brief Summary

Variable ventilation has been shown to improve lung function and reduce lung damage as well as inflammation in different models of the acute respiratory distress syndrome. Also, variable ventilation is able to recruit lungs. The present study will investigate whether variable as compared to non-variable ventilation improves post-operative lung function and reduces systemic inflammation in patients submitted to open abdominal surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2012

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, 2012

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

September 3, 2012

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 12, 2012

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

March 31, 2016

Status Verified

March 1, 2016

Enrollment Period

1 year

First QC Date

September 3, 2012

Last Update Submit

March 30, 2016

Conditions

Development of Pulmonary Dysfunction Following Open Abdominal Surgery

Keywords

mechanical ventilationlung functionabdominal surgery, opensystemic inflammation

Outcome Measures

Primary Outcomes (1)

  • Forced vital capacity

    Forced vital capacity is assessed on the first postoperative day

    Preoperative until 5th postoperative day

Secondary Outcomes (8)

  • Arterial partial CO2 pressure

    Preoperative until 5th postoperative day

  • Peak expiratory flow

    Preoperative until 5th postoperative day

  • Forced expiratory volume after 1 sec

    Preoperative until 5th postoperative day

  • PaO2/FIO2

    Preoperative until 5th postoperative day

  • Distribution of ventilation

    Preoperative until 5th postoperative day

  • +3 more secondary outcomes

Study Arms (2)

Variable Ventilation

ACTIVE COMPARATOR

Variable tidal volumes with mean at 8 mL/kg of predicted body weight

Other: Variable Ventilation

Non-variable Ventilation

NO INTERVENTION

Conventional mechanical ventilation with tidal volume 8 mL/kg of predicted body weight

Interventions

Variable VentilationOTHER
Variable Ventilation

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • elective open abdominal surgery
  • ASA classification 2-3
  • age between 18 und 85 yrs
  • expected duration of surgery \> 3 h
  • expected extubation in the operation room
  • written informed consent

You may not qualify if:

  • chronic lung disease (except to COPD stadium I and II, and asthma)
  • Body Mass Index (BMI) \> 40
  • allergy to one of the drugs to be used for general anesthesia
  • participation in another interventional trial within 4 weeks before enrollment
  • addiction or any other disease that may interfere with the capacity of giving informed consent
  • pregnant or breastfeeding women
  • women in reproductive age, except to those who fulfill one of the following:
  • post-menopause (12 months natural amenorrhoea, or 6 months amenorrhoea and serum FSH \> 40 mlU/ml
  • post-operative (6 weeks after two-sided ovariectomy)
  • routine and correct use of anticonceptional methods with failure rate \< 1 % per year
  • sexually not active
  • vasectomy of the partner
  • indication of low compliance with the protocol
  • contraindication for MRI examination

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesiology and Intensive Care, University Hospital Carl Gustav Carus

Dresden, Saxony, 01307, Germany

Location

Related Publications (2)

  • Spieth PM, Guldner A, Uhlig C, Bluth T, Kiss T, Conrad C, Bischlager K, Braune A, Huhle R, Insorsi A, Tarantino F, Ball L, Schultz MJ, Abolmaali N, Koch T, Pelosi P, Gama de Abreu M; PROtective Ventilation (PROVE) Network. Variable versus conventional lung protective mechanical ventilation during open abdominal surgery (PROVAR): a randomised controlled trial. Br J Anaesth. 2018 Mar;120(3):581-591. doi: 10.1016/j.bja.2017.11.078. Epub 2017 Dec 1.

    PMID: 29452815DERIVED

  • Spieth PM, Guldner A, Uhlig C, Bluth T, Kiss T, Schultz MJ, Pelosi P, Koch T, Gama de Abreu M. Variable versus conventional lung protective mechanical ventilation during open abdominal surgery: study protocol for a randomized controlled trial. Trials. 2014 May 2;15:155. doi: 10.1186/1745-6215-15-155.

    PMID: 24885921DERIVED

Related Links

Study Officials

  • Marcelo Gama de Abreu, MD, PhD

    Klinikum Ludwigshafen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 3, 2012

First Posted

September 12, 2012

Study Start

September 1, 2012

Primary Completion

September 1, 2013

Study Completion

September 1, 2013

Last Updated

March 31, 2016

Record last verified: 2016-03

Locations

DE(1)