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Optimizing Intraoperative Mechanical Ventilation Using EIT-titrated PEEP

Optimizing Intraoperative Mechanical Ventilation Using EIT-titrated PEEP

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02314845
Enrollment
40
Registered
2014-12-11
Start date
2014-08-31
Completion date
2016-04-30
Last updated
2016-05-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Atelectasis

Keywords

Pulmonary Atelectasis, Pulmonary Ventilation, Anesthesia, General, Electric Impedance, Tomography, Spiral Computed, Intraoperative Period

Brief summary

The purpose of this randomized single center study is to determine the individual PEEP value that produces the best possible compromise of lung collapse and lung hyperdistention. Patients submitted to general anesthesia and mechanical ventilation during surgery (laparoscopy and open surgery) will participate. A PEEP titration procedure will be performed and the optimal PEEP value will be determined by electrical impedance tomography (EIT). An ultrasound will be used to record each step of the PEEP titration procedure in a sub-sample of patients. A total of 40 patients will be mechanically ventilated using physiological tidal volume (TV=6mL/kg of IBW) and fraction of inspired oxygen (FIO2) of 0.5 and will be randomized to one of two groups: optimal PEEP or a low PEEP (4cmH2O). Lung collapse and mechanics will be monitored by EIT throughout the intraoperative period. After extubation, a lung CT will be performed to evaluate the amount of lung collapse.

Detailed description

Patients submitted to general anesthesia and mechanical ventilation commonly develop pulmonary atelectasis, which can cause adverse consequences either intraoperatively or postoperatively. The use of lower, more physiological tidal volumes (6-8 mL/Kg of ideal body weight) during the intraoperative period can minimize the risk of lung injury but may be associated with increased atelectasis. The application of PEEP can prevent the formation of atelectasis and minimize the resulting complications, but at the present time, there is no consensus on how to tailor the level of PEEP to best suit each patient. Electrical Impedance Tomography (EIT) is a portable non-invasive monitor that enables the analysis of lung function in a continuous mode. The aim of this study is to evaluate the use of Electrical Impedance Tomography (EIT), in the intraoperative period, as a tool for selecting optimal PEEP using a PEEP titration procedure, as well as assessing the evolution of pulmonary function during this period. The investigators will prospectively study a total of 40 adult patients (\> 18 years) divided into two subgroups: 20 laparoscopic surgery patients and 20 open surgery patients. After induction of anesthesia and neuromuscular blockade, all patients will be submitted to a recruitment maneuver in pressure-controlled ventilation (PCV) mode (PEEP = 20cmH2O, driving pressure = 20cmH2O, respiratory rate (RR) of 15 ipm and I:E ratio of 1:1) for 2 minutes followed by a decremental PEEP titration. The first step of the titration will start at a PEEP of 20 cmH2O and every 40 seconds PEEP will be decreased by 2 cmH2O, until a final PEEP of 4 cmH2O. A sub-sample of patients will have each step of the PEEP titration procedure recorded with an ultrasound and later evaluated by two different investigators. Optimal PEEP will be defined as that with the best compromise of atelectasis and overdistension as measured by EIT. Patients in each subgroup will be randomized to one of two ventilatory strategies: (1) PEEP chosen by the PEEP titration procedure; (2) PEEP set at 4 cmH2O. After a new recruitment maneuver PEEP will be set at the designated value and the patient will be ventilated with an inspired oxygen fraction of 50% or greater in order to maintain peripheral oxygen saturation (SpO2) \> 96%, a tidal volume of 6 mL/Kg and a respiratory rate to maintain an end tidal carbon dioxide (ETCO2) between 35-45. All patients will have their global and regional pulmonary mechanics monitored by EIT throughout the anesthetic procedure to assess the degree of pulmonary atelectasis. After extubation, patients will be referred to the Radiology Department for a chest CT.

Interventions

Optimal PEEP determined by EIT during a PEEP titration procedure.

Use of PEEP of 4 cmH2O during intraoperative period

Sponsors

Fundação de Amparo à Pesquisa do Estado de São Paulo
CollaboratorOTHER_GOV
University of Sao Paulo General Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients submitted to general anesthesia for surgical procedure

Exclusion criteria

* Age \< 18 years * Thoracic surgery (any) * ASA grade III or IV * History of moderate/severe chronic obstructive pulmonary disease (COPD) or moderate/severe Asthma * Moderate/severe restrictive lung disease * Use of heart pacemaker

Design outcomes

Primary

MeasureTime frameDescription
Optimal PEEP value6 minutesThe PEEP value, for each patient, that produces the best possible compromise of lung collapse and lung hyperdistention during a PEEP titration procedure using EIT

Secondary

MeasureTime frameDescription
Pulmonary atelectasis2-5 hoursThe amount of atelectasis, in percentage of lung mass, evaluated by EIT during intraoperative period and by chest CT scan after extubation
Ultrasound evaluation6 minutesThe use of ultrasound as a tool for PEEP titration intraoperatively compared to EIT

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 25, 2026