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Optimizing Intraoperative Mechanical Ventilation Using EIT-titrated PEEP

Primary Purpose

Pulmonary Atelectasis

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Optimal PEEP
Low PEEP
Sponsored by
University of Sao Paulo General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pulmonary Atelectasis focused on measuring Pulmonary Atelectasis, Pulmonary Ventilation, Anesthesia, General, Electric Impedance, Tomography, Spiral Computed, Intraoperative Period

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Sao Paulo General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Optimal PEEP

Low PEEP

Arm Description

Patients submitted to general anesthesia and abdominal laparoscopic surgery (number=10) or open surgery (number=10) will be submitted to a recruitment maneuver followed by a PEEP titration procedure using Electrical Impedance Tomography (EIT). Patients will be mechanically ventilated during intraoperative period using "Optimal PEEP" determined by Electrical Impedance and FIO2 of 0.5.

Patients submitted to general anesthesia and abdominal laparoscopic surgery (number=10) or open surgery (number=10) will be submitted to a recruitment maneuver followed by a PEEP titration procedure EIT. In this arm, the ventilator will be set with a PEEP=4 cmH2O ("Low PEEP") and FIO2 of 0.5 during intraoperative period.

Outcomes

Primary Outcome Measures

Optimal PEEP value
The 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 Outcome Measures

Pulmonary atelectasis
The amount of atelectasis, in percentage of lung mass, evaluated by EIT during intraoperative period and by chest CT scan after extubation
Ultrasound evaluation
The use of ultrasound as a tool for PEEP titration intraoperatively compared to EIT

Full Information

First Posted
November 7, 2014
Last Updated
May 10, 2016
Sponsor
University of Sao Paulo General Hospital
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT02314845
Brief Title
Optimizing Intraoperative Mechanical Ventilation Using EIT-titrated PEEP
Official Title
Optimizing Intraoperative Mechanical Ventilation Using EIT-titrated PEEP
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
August 2014 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
April 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo General Hospital
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Atelectasis
Keywords
Pulmonary Atelectasis, Pulmonary Ventilation, Anesthesia, General, Electric Impedance, Tomography, Spiral Computed, Intraoperative Period

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Optimal PEEP
Arm Type
Experimental
Arm Description
Patients submitted to general anesthesia and abdominal laparoscopic surgery (number=10) or open surgery (number=10) will be submitted to a recruitment maneuver followed by a PEEP titration procedure using Electrical Impedance Tomography (EIT). Patients will be mechanically ventilated during intraoperative period using "Optimal PEEP" determined by Electrical Impedance and FIO2 of 0.5.
Arm Title
Low PEEP
Arm Type
Other
Arm Description
Patients submitted to general anesthesia and abdominal laparoscopic surgery (number=10) or open surgery (number=10) will be submitted to a recruitment maneuver followed by a PEEP titration procedure EIT. In this arm, the ventilator will be set with a PEEP=4 cmH2O ("Low PEEP") and FIO2 of 0.5 during intraoperative period.
Intervention Type
Other
Intervention Name(s)
Optimal PEEP
Intervention Description
"Optimal PEEP" determined by EIT during a PEEP titration procedure.
Intervention Type
Other
Intervention Name(s)
Low PEEP
Intervention Description
Use of PEEP of 4 cmH2O during intraoperative period
Primary Outcome Measure Information:
Title
Optimal PEEP value
Description
The PEEP value, for each patient, that produces the best possible compromise of lung collapse and lung hyperdistention during a PEEP titration procedure using EIT
Time Frame
6 minutes
Secondary Outcome Measure Information:
Title
Pulmonary atelectasis
Description
The amount of atelectasis, in percentage of lung mass, evaluated by EIT during intraoperative period and by chest CT scan after extubation
Time Frame
2-5 hours
Title
Ultrasound evaluation
Description
The use of ultrasound as a tool for PEEP titration intraoperatively compared to EIT
Time Frame
6 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joaquim E Vieira, MD, PhD
Organizational Affiliation
University of Sao Paulo General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Sao Paulo General Hospital
City
Sao Paulo
State/Province
SP
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
33080407
Citation
Tonelotto B, Pereira SM, Tucci MR, Vaz DF, Vieira JE, Malbouisson LM, Gay F, Simoes CM, Carvalho Carmona MJ, Monsel A, Amato MB, Rouby JJ, Costa Auler JO Jr. Intraoperative pulmonary hyperdistention estimated by transthoracic lung ultrasound: A pilot study. Anaesth Crit Care Pain Med. 2020 Dec;39(6):825-831. doi: 10.1016/j.accpm.2020.09.009. Epub 2020 Oct 17.
Results Reference
derived
PubMed Identifier
30260897
Citation
Pereira SM, Tucci MR, Morais CCA, Simoes CM, Tonelotto BFF, Pompeo MS, Kay FU, Pelosi P, Vieira JE, Amato MBP. Individual Positive End-expiratory Pressure Settings Optimize Intraoperative Mechanical Ventilation and Reduce Postoperative Atelectasis. Anesthesiology. 2018 Dec;129(6):1070-1081. doi: 10.1097/ALN.0000000000002435.
Results Reference
derived

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Optimizing Intraoperative Mechanical Ventilation Using EIT-titrated PEEP

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