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Pulmonary Evaluation With Ultrasound in Different Levels of PEEP

NCT ID: NCT03211936

Last Updated: 2017-09-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-15

Study Completion Date

2017-04-15

Brief Summary

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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.

Detailed Description

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Conditions

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Atelectasis Hypertension Lung Edema

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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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

Group Type ACTIVE_COMPARATOR

PEEP TITRATED

Intervention Type PROCEDURE

After titrated peep levels, we choice this level of peep for de group (peep titrated)

Use ultrasound

Intervention Type DEVICE

We make a lung ultrasound after we setup a different level of PEEP

Impedance tomography

Intervention Type DEVICE

We use the impedance tomography to titrate peep levels, and acquire dates of collapse, hyperdistension and compliance.

PEEP 4

Intervention Type OTHER

We set the peep level after titrated peep = 4 cmH20.

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

Group Type EXPERIMENTAL

PEEP TITRATED

Intervention Type PROCEDURE

After titrated peep levels, we choice this level of peep for de group (peep titrated)

Use ultrasound

Intervention Type DEVICE

We make a lung ultrasound after we setup a different level of PEEP

Impedance tomography

Intervention Type DEVICE

We use the impedance tomography to titrate peep levels, and acquire dates of collapse, hyperdistension and compliance.

Best PEEP for less collapse

Intervention Type OTHER

After titrated PEEP levels we setup the best PEEP the according of tomography impedance

Interventions

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PEEP TITRATED

After titrated peep levels, we choice this level of peep for de group (peep titrated)

Intervention Type PROCEDURE

Use ultrasound

We make a lung ultrasound after we setup a different level of PEEP

Intervention Type DEVICE

Impedance tomography

We use the impedance tomography to titrate peep levels, and acquire dates of collapse, hyperdistension and compliance.

Intervention Type DEVICE

Best PEEP for less collapse

After titrated PEEP levels we setup the best PEEP the according of tomography impedance

Intervention Type OTHER

PEEP 4

We set the peep level after titrated peep = 4 cmH20.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

30 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Instituto do Cancer do Estado de São Paulo

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Maria Jose Carmona, PhD

Role: STUDY_CHAIR

University of Sao Paulo

Claudia Simões, PhD

Role: STUDY_DIRECTOR

Universiadde de São Paulo/ ICESP

Other Identifiers

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NP 807/15

Identifier Type: -

Identifier Source: org_study_id