NCT03064659

Brief Summary

During general anesthesia, functional residual capacity (FRC) is reduced. If the FRC is lower than the minimum volume required to maintain the opening of the airways, there is a derecruitment of the lung parenchyma, leading to the phenomenon of expiratory flow limitation (EFL). The Driving Pressure (DP) is the difference between the plateau pressure (Pplateau) and the Positive End-Expiratory Pressure (PEEP), and estimates the lung strain. The incidence of EFL and the importance of DP are not known in adult cardiac surgery, so it's necessary a study to assess both. The primary end-point of the study is to evaluate the correlation of DP and EFL with PPCs in adult cardiac surgery. The secondary end-point of the study is to evaluate: the mechanical ventilation time, the length of ICU and hospital stay, the rehospitalization and mortality. It will be a prospective, observational, non-pharmacological study. It will enroll 200 patients undergoing elective adult cardiac surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2015

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

November 1, 2015

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 17, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 27, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

May 23, 2017

Status Verified

May 1, 2017

Enrollment Period

1.2 years

First QC Date

February 17, 2017

Last Update Submit

May 22, 2017

Conditions

Respiratory FailurePneumothoraxAtelectasisRespiratory InfectionBronchospasmPleural Effusion

Keywords

Postoperative pulmonary complicationsDriving PressureLimitation of Expiratory FlowCardiac SurgeryCardio-pulmonary bypass

Outcome Measures

Primary Outcomes (2)

  • Expiratory Flow Limitation

    Through study completion, an average of 24 hours after surgery

  • Incidence of Driving Pressure

    Through study completion, an average of 24 hours after surgery

Secondary Outcomes (6)

  • Postoperative pulmonary complication

    Through study completion, an average of 7 days after surgery

  • ICU length of stay

    Through study completion, an average of 24 hours after surgery

  • Hospital length of stay

    Through study completion, an average of 7 days after surgery

  • Duration of mechanical ventilation

    Through study completion, an average of 7 days after surgery

  • PaO2/ FiO2

    Through study completion, an average of 24 hours after surgery

  • +1 more secondary outcomes

Eligibility Criteria

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

Adult Undergoing Elective Cardiac Surgery

You may qualify if:

  • Age \> 18 years old
  • Ability to provide an informed consent
  • Planned cardiac surgery with median sternotomy and bi-pulmonary ventilation
  • patients scheduled for adult elective cardiac surgery, performed with CPB and aortic cross-clamping.

You may not qualify if:

  • Patient refusal to provide informed consent
  • Emergency surgery
  • Cardiac surgery with TAVI/MitraClip
  • Planned thoracotomy with one lung ventilation
  • Patients with chronic kidney insufficiency (defined as dialysis)
  • Patients already intubated in the peri-operative period
  • Patients with pneumonia in the pre-operative period (30 days before surgery)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ospedale San Raffaele

Milan, MI, 20132, Italy

Location

Related Publications (1)

  • Grieco DL, Chen L, Dres M, Brochard L. Should we use driving pressure to set tidal volume? Curr Opin Crit Care. 2017 Feb;23(1):38-44. doi: 10.1097/MCC.0000000000000377.

    PMID: 27875410BACKGROUND

MeSH Terms

Conditions

Respiratory InsufficiencyPneumothoraxPulmonary AtelectasisRespiratory Tract InfectionsBronchial SpasmPleural Effusion

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesPleural DiseasesLung DiseasesInfectionsBronchial Diseases

Study Officials

  • Elena Bignami, MD

    Ospedale San Raffaele

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Month
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

February 17, 2017

First Posted

February 27, 2017

Study Start

November 1, 2015

Primary Completion

January 1, 2017

Study Completion

May 1, 2017

Last Updated

May 23, 2017

Record last verified: 2017-05

Locations

IT(1)