Mechanical Ventilation During Cardiac Surgery

NCT02090205 | Unknown DMC

• 1 other identifier: CPBVENT2014
• Study Type: interventional
• Target: 780
• Locations: 1 country
• Sites: 13

Brief Summary

Background There is no unanimous opinion about a lung-protective strategy in cardiac surgery. Small randomized clinical and animals trials suggest that ventilation during cardio-pulmonary bypass (CPB) could be protective on the lungs. This evidence is based on surrogate end-points and most of studies are limited to elective coronary surgery. According to the available data, an optimal strategy of lung protection during CPB cannot be recommended. The purpose of the CPBVENT study is to investigate the effectiveness of different ventilation strategies during CPB on post-operative pulmonary complications. Trial design The CPBVENT study will be a single-blind, multicenter, randomized controlled trial. We are going to enroll 780 patients undergoing elective cardiac surgery with planned use of CPB, aortic cross-clamping and two lung ventilation. Patients will be randomized into three treatment groups: 1) no ventilation during CPB; 2) continuous positive airway pressure (CPAP) with positive end-expiratory pressure (PEEP) of 5 cmH2O during CPB; 3) ventilation with 5 acts/minute with tidal volume of 2-3 ml/Kg and a PEEP of 3-5 cmH2O during CPB. The primary end-point will be the incidence of a PaO2/FiO2 ratio \<200 until the time of discharge from the ICU. The secondary end-points will be the incidence of post-operative pulmonary complications and 30-days mortality. Patients will be followed-up to 12 months after the date of randomization. Summary The CPBVENT Trial will determine whether different ventilation strategies during CPB will improve pulmonary outcome in patients undergoing cardiac surgery.

Conditions

Respiratory Failure; Pneumothorax; Atelectasis; Aspiration Pneumonia; Bronchospasm

Keywords

cardio-pulmonary bypass; cardiac surgery; lung injury prevention; mechanical ventilation; pulmonary insufficiency

Outcome Measures

Primary Outcomes (1)

• Incidence of postoperative pulmonary complications

  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.

  Up to 1 year

Study Arms (3)

Non-ventilation during CPB

PLACEBO COMPARATOR

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

Ventilation with CPAP

EXPERIMENTAL

This group will receive a ventilation with CPAP (at least 5 cmH2O) and FiO2 50%-80%

Procedure: Ventilation with CPAP; Device: CPAP

Ventilation with 5 act/minute

EXPERIMENTAL

This group will receive 5 respiratory acts/minute. Tidal volume = 2-3 ml/kg + PEEP = 3-5 cmH2O.

Procedure: Ventilation with 5 act/minute; Device: Ventilator: 5 act/minute

Interventions

Non-ventilation during CPB PROCEDURE

Patients that will not be ventilated during cardio-pulmonary bypass

Non-ventilation during CPB

Ventilation with CPAP PROCEDURE

These patients will receive CPAP (at least 5 cmH2O and FiO2 50%-80%)

Ventilation with CPAP

Ventilation with 5 act/minute PROCEDURE

These patients will receive mechanical ventilation (5 acts/minute) during CPB

Ventilation with 5 act/minute

CPAP DEVICE

Continuous Positive Air Pressure, applicated during cardio-pulmonary bypass

Ventilation with CPAP

Ventilator: 5 act/minute DEVICE

Tidal volume = 2-3 ml/kg + PEEP = 3-5 cmH2O.

Ventilation with 5 act/minute

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Ospedale San Raffaele: lead

Study Sites (13)

Spedali Civili

Brescia, Brescia, 25128, Italy

NOT YET RECRUITING

Azienda Ospedaliera Brotzu

Cagliari, Cagliari, 09134, Italy

NOT YET RECRUITING

P.O. Pineta Grande

Castel Volturno, Caserta, 81030, Italy

RECRUITING

Ospedale San Martino

Genova, Genova, 16132, Italy

NOT YET RECRUITING

IRCCS Monzino

Milan, MI, 20138, Italy

NOT YET RECRUITING

Ospedale San Raffaele

Milan, MI, 20132, Italy

RECRUITING

Azienda Ospedaliero-Universitaria di Parma

Parma, Parma, 43126, Italy

RECRUITING

Azienda Ospedaliera di Perugia

Perugia, Perugia, 06156, Italy

RECRUITING

Azienda Ospedaliera San Carlo

Potenza, Potenza, 85100, Italy

NOT YET RECRUITING

Policlinico universitario Campus biomedico

Roma, Roma, 00128, Italy

RECRUITING

Policlinico Universitario Agostino Gemelli

Roma, Roma, 00168, Italy

NOT YET RECRUITING

Azienda Ospedaliera Universitaria Senese

Siena, Siena, 53100, Italy

RECRUITING

A.O.U. Santa Maria della misericordia

Udine, Udine, 33100, Italy

RECRUITING

Related Publications (1)

• Bignami E, Guarnieri M, Saglietti F, Maglioni EM, Scolletta S, Romagnoli S, De Paulis S, Paternoster G, Trumello C, Meroni R, Scognamiglio A, Budillon AM, Pota V, Zangrillo A, Alfieri O. Different strategies for mechanical VENTilation during CardioPulmonary Bypass (CPBVENT 2014): study protocol for a randomized controlled trial. Trials. 2017 Jun 7;18(1):264. doi: 10.1186/s13063-017-2008-2.

  PMID: 28592276 DERIVED

MeSH Terms

Conditions

Respiratory Insufficiency; Pneumothorax; Pulmonary Atelectasis; Pneumonia, Aspiration; Bronchial Spasm

Interventions

Ventilation

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Pleural Diseases; Lung Diseases; Pneumonia; Respiratory Tract Infections; Infections; Bronchial Diseases

Intervention Hierarchy (Ancestors)

Environment, Controlled; Environment; Environment and Public Health

Study Officials

• Elena Bignami, MD

  San Raffaele Hospital, Milan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elena Bignami, MD

CONTACT

39.02.2643.4524; bignami.elena@hsr.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: March 8, 2014
• First Posted: March 18, 2014
• Study Start: November 1, 2014
• Primary Completion: December 1, 2016
• Study Completion: June 1, 2017
• Last Updated: February 2, 2016

Record last verified: 2016-02

Locations

IT (13)