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Completed

NCT Number: NCT03211936

Pulmonary Evaluation With Ultrasound in Different Levels of PEEP

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.

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Key information

Age range

30 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PEEP TITRATED

Procedure

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

Use ultrasound

Device

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

Impedance tomography

Device

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

Best PEEP for less collapse

Other

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

PEEP 4

Other

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

Primary outcomes

  1. Hyperdistension

    Time frame: during tritiate peep

    We acquire lung ultrasound images during tritiating peep and analyze if any patient have hyperdistension

Secondary outcomes

  1. Atelectasis

    Time frame: in the final of the procedure

    After the procedure we analyze with patient group have more atelectasis

Sponsors and collaborators

Lead sponsor

Instituto do Cancer do Estado de São Paulo

Other

Registry information

Official study title

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

Acronym: EVALUS

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Jul 11, 2017
Registry last updated
Sep 20, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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