Pulmonary Evaluation With Ultrasound in Different Levels of PEEP (EVALUS)

Pulmonary Evaluation at Different Levels of PEEP: Ultrasonography Compared to Electrical Impedance Tomography (TIE) During Intraoperative Elective Surgeries

Patients submitted to general anesthesia and artificial ventilation almost always develop pulmonary atelectasis, which can determine adverse consequences both intraoperatively and postoperatively. It is recommended to use physiological tidal volume (6 - 8 mL / kg of ideal body weight) during the intraoperative period in order to minimize the risk of lung injury. To prevent the formation of atelectasis, minimizing the risk of complications, the use of PEEP has been recommended. At present, there is no way to make an optimal adjustment of PEEP to the needs of each patient, seeking a value that keeps the alveoli open without forming atelectasis and also without areas of hyperdistension.

The aim of this study was to evaluate the agreement between the ultrasound and the electrical impedance tomography - Timpel® (TIE) to detect the beginning of the formation of areas of atelectasis after pulmonary recruitment, with decreasing PEEP values. In addition, the lung ultrasound will be validated for intraoperative use for both adequacy of PEEP, as well as quantitative analyzes of ultrasound images to assess atelectasis.

18 patients (> 18 years) of both sexes, submitted to general anesthesia, will be prospectively studied. All patients will receive, in addition to the usual monitoring, the monitoring with the electrical impedance tomography and chest ultrasonography, after being anesthetized and under neuromuscular block, being ventilated with an inspired fraction of 50% oxygen (or greater to maintain oxygen saturation > 96% ), Tidal volume of 6 mL / kg and respiratory rate to maintain expiratory tidal CO2 between 35-45 cmH2O.

Study Overview

• Status: Completed
• Conditions: Hypertension; Atelectasis; Lung Edema
• Intervention / Treatment: Procedure: PEEP TITRATED; Device: Use ultrasound; Device: Impedance tomography; Other: PEEP 4; Other: Best PEEP for less collapse

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 26 years to 56 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Participants will be male and female patients, over 18 years of age, who undergo abdominal surgeries (prostatectomies and hysterectomies) and who do not have preexisting pulmonary diseases. They will be approached in the room prior to surgery, at which time the purpose of the research will be explained, besides making clear that it will not entail costs and so little any injury, scar, or damage. If accepted by the patient, the consent form will be applied.

Exclusion Criteria:

• Exclusion criteria for the study will be: patients classified by the American Society of Anesthesiologists Physical status as ASA-3 or above, patients with obstructive and restrictive respiratory diseases, patients with predictable orotracheal intubation difficulties (eg, obese patients) who require Manipulation of the upper airways. Also excluded are patients with pacemakers and patients scheduled for procedures in the thoracic region

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: PEEP 4; We titrate peep, using tomography impedance, making ultrasound after "level by level' of peep. After titrated peep we setup peep 4 and maintained during the procedure.; PEEP 4 cmH2O; Use ultrasound	Procedure: PEEP TITRATED; After titrated peep levels, we choice this level of peep for de group (peep titrated); Device: Use ultrasound; We make a lung ultrasound after we setup a different level of PEEP; Device: Impedance tomography; We use the impedance tomography to titrate peep levels, and acquire dates of collapse, hyperdistension and compliance.; Other: PEEP 4; We set the peep level after titrated peep = 4 cmH20.
Experimental: PEEP TITRATED; We titrate peep, using tomography impedance, making ultrasound after "level by level' of peep. After tritiated peep we setup the best peep for less collapse (using the tomography of electrical impedance) and maintained during the procedure.; PEEP titrated; Use ultrasound; Impedance tomography; Best PEEP for less collapse	Procedure: PEEP TITRATED; After titrated peep levels, we choice this level of peep for de group (peep titrated); Device: Use ultrasound; We make a lung ultrasound after we setup a different level of PEEP; Device: Impedance tomography; We use the impedance tomography to titrate peep levels, and acquire dates of collapse, hyperdistension and compliance.; Other: Best PEEP for less collapse; After titrated PEEP levels we setup the best PEEP the according of tomography impedance

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hyperdistension	We acquire lung ultrasound images during tritiating peep and analyze if any patient have hyperdistension	during tritiate peep

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Atelectasis	After the procedure we analyze with patient group have more atelectasis	in the final of the procedure

Collaborators and Investigators

• Sponsor: Instituto do Cancer do Estado de São Paulo
• Investigators: Study Chair: Maria Jose Carmona, PhD, University of Sao Paulo; Study Director: Claudia Simões, PhD, Universiadde de São Paulo/ ICESP

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2015
• Primary Completion (Actual): February 15, 2017
• Study Completion (Actual): April 15, 2017

Study Registration Dates

• First Submitted: April 20, 2017
• First Submitted That Met QC Criteria: July 5, 2017
• First Posted (Actual): July 11, 2017

Study Record Updates

• Last Update Posted (Actual): September 20, 2017
• Last Update Submitted That Met QC Criteria: September 18, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Pulmonary Atelectasis
• Other Study ID Numbers: NP 807/15

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No