NCT01502332

Brief Summary

The purpose of this study was to evaluate prospectively the impact of two protective mechanical ventilation strategies, both using low tidal volume ventilation (6 mL/kg/ibw) after cardiac surgery. The study selected patients presenting signals of deficient gas exchange (PaO2/FIO2 \< 250 at a PEEP \[positive end expiratory pressure\] of 5 cmH2O) in the immediate post-operative period. An aggressive alveolar recruitment protocol applying opening pressures of 45 cmH2O, followed by ventilation with PEEP = 13 cmH2O, was compared to the standard alveolar recruitment protocol of the institution, where an opening pressure of 20 cmH2O in the airways is followed by ventilation with PEEP = 8 cmH2O. After a stabilizing period of four hours of controlled mechanical ventilation, the patients followed the routine weaning protocol and physiotherapy protocol of the institution.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
320

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2011

Typical duration for not_applicable

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

December 1, 2011

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

December 21, 2011

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 30, 2011

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
2.7 years until next milestone

Results Posted

Study results publicly available

November 23, 2016

Completed
Last Updated

November 23, 2016

Status Verified

October 1, 2016

Enrollment Period

2.2 years

First QC Date

December 21, 2011

Results QC Date

July 21, 2016

Last Update Submit

October 1, 2016

Conditions

Ventilator Induced Lung InjuryCardiac DiseaseAcute Lung Injury

Keywords

Mechanical ventilationOpen lung approachBlood gasesCardiac surgeryPulmonary complications

Outcome Measures

Primary Outcomes (1)

  • Severity of Pulmonary Complications in the Post-operative Period

    Score of pulmonary complications adapted from previous publications, with 5 degrees, where the higher one means death before hospital discharge, degree (4) means the need of mechanical ventilation for more than 48 hours after surgery or after reintubation, degree (3) means pneumonia or intense noninvasive ventilation need, degree (2) means hypoxemia and abnormal lung findings, degree 1 means simple atelectasis and degree (0) means no complication. The comparison used this ordinal variable, representing the highest score achieved during the post-operative period. The comparison between arms was made through the Mann-Whitney U test. Data shown are percentage of participants with pulmonary complications grade ≥ 3.

    Participants were followed for the duration of hospital stay.

Secondary Outcomes (4)

  • Length of ICU Stay

    From the day of surgery up to ICU discharge, maximum censoring at day 28 after surgery

  • Length of Hospital Stay

    From the day of surgery up to Hospital discharge, maximum censoring at day 28 after surgery

  • Incidence of Barotrauma

    Five days after surgery

  • Hospital Mortality

    From the day of surgery up to Hospital discharge or death, with no maximum censoring.

Study Arms (2)

Intensive Alveolar Recruitment

EXPERIMENTAL

Recruitment with opening pressures of 45 cmH2O in the airways.

Other: Intensive Alveolar Recruitment

Moderate Alveolar Recruitment

ACTIVE COMPARATOR

Recruitment with opening pressures of 20 cmH2O in the airways.

Other: Moderate Alveolar Recruitment

Interventions

Intensive Alveolar RecruitmentOTHER

Recruitment with opening pressures of 45 cmH2O in the airways, followed by ventilation with PEEP = 13 cmH2O, during 4 hours of protective mechanical ventilation with tidal volume (VT) = 6 mL/kg/pbw.

Intensive Alveolar Recruitment
Moderate Alveolar RecruitmentOTHER

Recruitment with opening pressures of 20 cmH2O in the airways, followed by ventilation with PEEP = 8 cmH2O, during 4 hours of protective mechanical ventilation with VT = 6 mL/kg/pbw.

Moderate Alveolar Recruitment

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Immediate postoperative period of myocardial revascularization and/or heart valve surgery (aortic and/or mitral)
  • Age \> 18 years and \< 80 years
  • No previous pulmonary disease
  • Left ventricular ejection fraction \> 35%
  • Body mass index \< 40 kg/m2
  • Oxygen index (PaO2/FiO2) \< 250
  • Corrected volemic status (negative raising legs mean arterial pressure \[MAP\] variation \< 10%)
  • Written inform consent

You may not qualify if:

  • MAP (mean arterial pressure) \< 60 mmHg
  • Noradrenaline \> 2 micrograms/Kg/min
  • Acute arrhythmias
  • Blooding associated to hemodynamic instability
  • Need of re-surgery and/or mechanical circulatory assistance
  • Suspicion of neurological alteration
  • Chest tube with persistent air leak

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto do Coração (Incor) - University of São Paulo

São Paulo, São Paulo, Brazil

Location

Related Publications (1)

  • Costa Leme A, Hajjar LA, Volpe MS, Fukushima JT, De Santis Santiago RR, Osawa EA, Pinheiro de Almeida J, Gerent AM, Franco RA, Zanetti Feltrim MI, Nozawa E, de Moraes Coimbra VR, de Moraes Ianotti R, Hashizume CS, Kalil Filho R, Auler JO Jr, Jatene FB, Gomes Galas FR, Amato MB. Effect of Intensive vs Moderate Alveolar Recruitment Strategies Added to Lung-Protective Ventilation on Postoperative Pulmonary Complications: A Randomized Clinical Trial. JAMA. 2017 Apr 11;317(14):1422-1432. doi: 10.1001/jama.2017.2297.

    PMID: 28322416DERIVED

MeSH Terms

Conditions

Ventilator-Induced Lung InjuryHeart DiseasesAcute Lung Injury

Condition Hierarchy (Ancestors)

Lung InjuryLung DiseasesRespiratory Tract DiseasesCardiovascular Diseases

Results Point of Contact

Title
Dr Alcino Costa Leme
Organization
USaoPaulo
costaleme@uol.com.br
55 11 989044014

Study Officials

  • Marcelo BP Amato, PhD

    University of Sao Paulo

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Supervisor of respiratory post-operative care - Incor Heart Institute

Study Record Dates

First Submitted

December 21, 2011

First Posted

December 30, 2011

Study Start

December 1, 2011

Primary Completion

February 1, 2014

Study Completion

March 1, 2014

Last Updated

November 23, 2016

Results First Posted

November 23, 2016

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)