Mechanical Ventilation During Cardiac Surgery

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified March 2014 by Ospedale San Raffaele
Sponsor:
Information provided by (Responsible Party):
Elena Bignami, Ospedale San Raffaele
ClinicalTrials.gov Identifier:
NCT02090205
First received: March 8, 2014
Last updated: March 16, 2014
Last verified: March 2014
  Purpose

Respiratory insufficiency is a common complication after cardiac surgery, ranging between mild subclinical events to severe acute respiratory distress syndrome (ARDS). Physiopathology is complex and involves atelectasis, hyper-oxygenation and systemic inflammatory activation, with recruitment of neutrophils and increased pulmonary vascular permeability. The practice of stopping mechanical ventilation during cardio-pulmonary bypass (CPB) is widely diffused, because it is not necessary to maintain blood oxygenation and elimination of carbon dioxide, and furthermore respiratory movements can interfere with the surgical procedure. Nevertheless the ventilation stop during CPB is associated with the formation of post-operative micro-atelectasis, idiopathic pulmonary edema, higher incidence of infections and alterations of respiratory mechanics. Moreover the movement of compression/decompression of pulmonary tissue can be important for pulmonary lymphatic flow. Recent studies suggest that the application of a CPAP during CPB can reduce the post-operative shunt fraction. Similar results can be achieved with recruitment maneuvers before the end of the CPB. Mechanical ventilation during the CPB seem to reduce the systemic inflammatory response.

In this study we want to test the hypothesis that a mechanical ventilation at low frequency/volume or the application of a CPAP ventilation during CPB can reduce the incidence of post-operative pulmonary complications. This is a randomized controlled multi-centric trial.


Condition Intervention
Respiratory Failure
Pneumothorax
Atelectasis
Aspiration Pneumonia
Bronchospasm
Procedure: Non-ventilation during CPB
Procedure: Ventilation with CPAP
Procedure: Ventilation with 5 act/minute
Device: CPAP
Device: Ventilator: 5 act/minute

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Mechanical Ventilation During Cardiac Surgery, a Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Ospedale San Raffaele:

Primary Outcome Measures:
  • Incidence of postoperative pulmonary complications [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]
    We aim to assess the number of incidence (defined as percentage of all events) of post-operative pulmonary complications up to 1 year after the surgical intervention. Our goal is to reduce this number with the ventilation during cardio-pulmonary bypass.


Estimated Enrollment: 766
Study Start Date: June 2014
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Non-ventilation during CPB
This group of patients will not be ventilated during the cardio-pulmonary bypass. They will be disconnected from the respirator.
Procedure: Non-ventilation during CPB
Patients that will not be ventilated during cardio-pulmonary bypass
Experimental: Ventilation with CPAP
This group will receive a ventilation with CPAP (at least 5 cmH2O) and FiO2 50%-80%
Procedure: Ventilation with CPAP
These patients will receive CPAP (at least 5 cmH2O and FiO2 50%-80%)
Device: CPAP
Continuous Positive Air Pressure, applicated during cardio-pulmonary bypass
Experimental: Ventilation with 5 act/minute
This group will receive 5 respiratory acts/minute. Tidal volume = 2-3 ml/kg + PEEP = 3-5 cmH2O.
Procedure: Ventilation with 5 act/minute
These patients will receive mechanical ventilation (5 acts/minute) during CPB
Device: Ventilator: 5 act/minute
Tidal volume = 2-3 ml/kg + PEEP = 3-5 cmH2O.

Detailed Description:

Our primary endpoints will be:

  • To reduce the PaO2 / FiO2 ratio (arterial oxygen partial pressure/fraction of inspired oxygen) in patients treated with mechanical ventilation during CPB
  • To reduce the incidence of post-operative pulmonary complications in patients with mechanical ventilation during CPB.

Post-operative pulmonary complications are defined as:

  • respiratory infections
  • postoperative respiratory failure
  • pleural effusion
  • pneumothorax
  • atelectasis
  • aspiration pneumonia
  • bronchospasm

Our secondary endpoints will be to reduce the incidence of:

  • postoperative infections
  • cardiovascular complications
  • postoperative residual curarization (PORC)
  • duration of ventilatory support
  • need of re-intubation
  • need of non-invasive mechanical ventilation
  • need of ICU admission and ICU length of stay
  • total length of hospitalization
  • mortality during hospitalization and postoperative outcome (assessed at 30, 60 days and 1 year after hospital discharge)

Data will be collected by each center in an appropriate Case Report Form and sent to the coordinator center for the statistical analysis. Statistical analysis will be performed after all data will be collected, using the statistical softwares Epi Info 2002 (CDC), SPSS 11.0 (SPSS), and STATA 9.0 (STATA), when appropriate.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age > 18 years old
  • Ability to provide an informed consent
  • Elective surgery
  • Surgical intervention with cardio-pulmonary bypass, aortic clamp and cardioplegia
  • Cardiac valvular surgery, coronary artery surgery, ascending aortic surgery and/or combined
  • Planned cardiac surgery with median sternotomy and bi-pulmonary ventilation

Exclusion Criteria:

  • Patient refusal to provide informed consent
  • Emergency surgery
  • Patients with previous cardiac surgery
  • Cardiac surgery with planned circulatory arrest or aortic endoprosthesis or TAVI/MitraClip
  • Planned thoracotomy with one lung ventilation
  • Patients with BMI >30
  • Patients with chronic kidney insufficiency (defined as dialysis)
  • Patients with known respiratory diseases (current respiratory infections, asthma, chronic obstructive pulmonary disease, obstructive apnea syndrome)
  • Patients already intubated in the peri-operative period
  • Patients with pneumonia in the pre-operative period (30 days before surgery)
  • Patients with previous thoracic surgery (pulmonary resection)
  • Patients with: oxygen saturation < 90% and/or oxygen arterial pressure < 60 mmHg and/or P/F ratio <300 and/or carbon dioxide pressure > 45 mmHg
  • Patients with levels of aspartate aminotransferase (AST) or alanine aminotransferase (ALT) levels increased >= 2 folds above the upper limit.
  • Patients with ejection fraction < 40%
  • Patients with pulmonary hypertension (defined as PAPm > 30mmHg)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02090205

Contacts
Contact: Elena Bignami, MD 39.02.2643.4524 bignami.elena@hsr.it

Locations
Italy
IRCCS Monzino Not yet recruiting
Milan, MI, Italy, 20138
Contact: Paola Moliterni, MD    02580021    paolamoliterni@libero.it   
Principal Investigator: Paola Moliterni, MD         
Ospedale San Raffaele Not yet recruiting
Milano, MI, Italy, 20132
Contact: Elena Bignami, MD    39.02.2643.4524    bignami.elena@hsr.it   
Principal Investigator: Elena Bignami, MD         
Sponsors and Collaborators
Ospedale San Raffaele
Investigators
Principal Investigator: Elena Bignami, MD San Raffaele Hospital, Milan
  More Information

No publications provided

Responsible Party: Elena Bignami, MD, Ospedale San Raffaele
ClinicalTrials.gov Identifier: NCT02090205     History of Changes
Other Study ID Numbers: CPBVENT2014
Study First Received: March 8, 2014
Last Updated: March 16, 2014
Health Authority: Italy: Ministry of Health

Keywords provided by Ospedale San Raffaele:
cardio-pulmonary bypass
cardiac surgery
lung injury prevention
mechanical ventilation
pulmonary insufficiency

Additional relevant MeSH terms:
Pneumonia, Aspiration
Respiratory Insufficiency
Pneumothorax
Bronchial Spasm
Respiration Disorders
Respiratory Tract Diseases
Pleural Diseases
Bronchial Diseases
Pneumonia
Lung Diseases
Respiratory Tract Infections

ClinicalTrials.gov processed this record on September 18, 2014