NCT02654600

Brief Summary

the decrease in thoracopulmonary compliance after cardiac surgery is well known . The investigators hypothesize that the major factor determining pulmonary outcome after cardiac surgery is the alteration of pulmonary compliance during cardiopulmonary bypass(CBP) and that this alteration is due to CBP itself through pulmonary blood emptying.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2014

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

June 1, 2014

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

September 2, 2015

Completed
4 months until next milestone

First Posted

Study publicly available on registry

January 13, 2016

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

May 23, 2017

Status Verified

May 1, 2017

Enrollment Period

Same day

First QC Date

September 2, 2015

Last Update Submit

May 21, 2017

Conditions

Thoracic SurgeryCardiopulmonary Bypass

Keywords

cardiac surgerythoracopulmonary compliance

Outcome Measures

Primary Outcomes (1)

  • pulmonary compliance during cardiac surgery

    compliance is calculated by dividing tidal volume (ml) by the difference between plateau-inspiratory pressure (mmHg) and end-expiratory pressure (mmHg) before ,during and after CBP

    intraoperative

Secondary Outcomes (2)

  • pulmonary complications including death after cardiac surgery

    1 month

  • thoracopulmonary compliance during cardiac surgery

    intraoperative

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Every ASA 2 or 3 patient eligible for non-complex and non-urgent cardiac surgery

You may qualify if:

  • scheduled for standard aortic
  • mitral or coronary surgery

You may not qualify if:

  • emergency operation
  • no complete preoperative echocardiography
  • surgery needing multiple table position changes
  • unstable cardiac or respiratory condition
  • difficult patient needing multiple care and/or special attention

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Chirurgical Marie Lannelongue

Le Plessis-Robinson, 92350, France

Location

Related Publications (2)

  • Ellison LT, Duke JF 3rd, Ellison RG. Pulmonary compliance following open-heart surgery and its relationship to ventilation and gas exchange. Circulation. 1967 Apr;35(4 Suppl):I217-25. doi: 10.1161/01.cir.35.4s1.i-217. No abstract available.

    PMID: 6024032BACKGROUND

  • Suter PM, Fairley HB, Isenberg MD. Effect of tidal volume and positive end-expiratory pressure on compliance during mechanical ventilation. Chest. 1978 Feb;73(2):158-62. doi: 10.1378/chest.73.2.158.

    PMID: 340159BACKGROUND

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 2, 2015

First Posted

January 13, 2016

Study Start

June 1, 2014

Primary Completion

June 1, 2014

Study Completion

June 1, 2016

Last Updated

May 23, 2017

Record last verified: 2017-05

Locations

FR(1)