Individualized Perioperative Open-Lung Ventilatory Strategy During One-Lung Ventilation

Surgery Time Expected More Than Two Hours Clinical Trial

— iPROVE-OLV  

Official title:

Postoperative Complication and Hospital Stay Reduction With a Individualized Perioperative Lung Protective Ventilation During One-lung Ventilation: A Prospective, Multicenter, Randomized Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03182062
• Other study ID #: iPROVE-OLV
• Status: Recruiting
• Phase: N/A
• Start date: September 8, 2018
• Est. completion date: July 2020

Study information

• Verified date: October 2018
• Source: Fundación para la Investigación del Hospital Clínico de Valencia
• Contact: Carlos Ferrando, MD, PhD
• Phone: 609892732
• Email: cafeoranestesia[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether individualized ventilatory management during one-lung ventilation in patients scheduled for thoracic surgery, combining the use of low tidal volumes, alveolar recruitment maneuvers, individually titrated positive end-expiratory pressure and individually indicated ventilatory support will decrease postoperative pulmonary complications, ICU and hospital length of stay compared to a standardized Lung Protective Ventilation (LPV).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1400
• Est. completion date: July 2020
• Est. primary completion date: January 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Planned thoracic surgery > 2 hours.

• Signed informed consent for participation in the study.

Exclusion Criteria:

• Age less than 18 years.

• Pregnant or breast-feeding.

• Patients with BMI >35.

• Syndrome of moderate or severe respiratory distress: PaO2/FiO2 < 200 mmHg.

• Heart failure: NYHA IV.

• Hemodynamic failure: CI <2.5 L/min/m2 and / or requirements before surgery ionotropic support.

• Diagnosis or suspicion of intracranial hypertension (intracranial pressure> 15 mmHg).

• Mechanical ventilation in the last 15 days.

• Presence of pneumothorax. Presence of giant bullae on chest radiography or computed tomography (CT).

• Patient with preoperatively CPAP.

• Participation in another experimental protocol at the time of intervention selection.

Related Conditions & MeSH terms

• Postoperative Complications
• Surgery Time Expected More Than Two Hours
• Thoraric Surgery

Intervention

Procedure:
• Alveolar recruitment maneuver
To start the Alveolar Recruitment Maneuver (ARM) the ventilatory mode will be changed to pressure-controlled mode (PCV) with 20 cmH2O pressure control ventilation. A respiratory rate (RR) of 15 rpm, inspiration: expiration ratio of 1:1, FiO2 of 0.8 and PEEP of 5 cmH2O. The PEEP level will be increased in 5 cmH2O steps every 10 respiratory cycles, increasing to 15 cycles in the last level of PEEP (20 cmH2O), getting an opening pressure at 40 cmH2O airway (duration of the maneuver: 160 sec.)
• PEEP Titration Trial
The ventilation mode will then switch back to volume controlled ventilation with the same baseline settings but with 20 cmH2O PEEP level. Then PEEP will be reduced in 2 cmH2O steps each maintained for 5 breaths the level of PEEP with the best (higher) dynamic compliance.
• Lung protective ventilation
Ventilatory strategy with a PEEP level of 5 cmH2O but without recruitment maneuvers and PEEP titration trial.

Locations

Country	Name	City	State
Spain	Hospital Germans Trias i Pujol	Badalona	Barcelona
Spain	Hospital de la Santa Creu i Sant Pau	Barcelona
Spain	Hospital Gregorio Marañón	Madrid
Spain	Hospital clínico universitario	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
Fundación para la Investigación del Hospital Clínico de Valencia

Country where clinical trial is conducted

Spain, 

References & Publications (3)

Ferrando C, Mugarra A, Gutierrez A, Carbonell JA, García M, Soro M, Tusman G, Belda FJ. Setting individualized positive end-expiratory pressure level with a positive end-expiratory pressure decrement trial after a recruitment maneuver improves oxygenation — View Citation

Fleisher LA, Linde-Zwirble WT. Incidence, outcome, and attributable resource use associated with pulmonary and cardiac complications after major small and large bowel procedures. Perioper Med (Lond). 2014 Oct 7;3:7. doi: 10.1186/2047-0525-3-7. eCollection — View Citation

Licker MJ, Widikker I, Robert J, Frey JG, Spiliopoulos A, Ellenberger C, Schweizer A, Tschopp JM. Operative mortality and respiratory complications after lung resection for cancer: impact of chronic obstructive pulmonary disease and time trends. Ann Thora — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction of postoperative pulmonary complications	composite of pulmonary infection, severe respiratory failure, acute respiratory distress syndrome, pneumothorax, bronchopleural fistula, atelectasis requiring bronchoscopy, empyema.	Up to 7 postoperative days
Secondary	Reduction of composite of postoperative pulmonary complications	suspicion of pulmonary infection, mild acute respiratory failure, severe respiratory failure, acute respiratory distress syndrome	Up to 30 postoperative days
Secondary	Reduction of composite of postoperative complications	Renal failure, cardiac failure, sepsis, septic shock, surgical site infection, urinary infection and other pulmonary complications not included in the primary outcome such as leaks, atelectasis, pleural effusion, empyema, dyspnea.	Up to 7 and 30 postoperative days
Secondary	Intensive care unit and hospital length of stay reduction		1 year