Pulmonary Evaluation With Ultrasound in Different Levels of PEEP

Hypertension Clinical Trial

— EVALUS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03211936
• Other study ID #: NP 807/15
• Status: Completed
• Phase: N/A
• First received: April 20, 2017
• Last updated: September 18, 2017
• Start date: December 15, 2015
• Est. completion date: April 15, 2017

Study information

• Verified date: September 2017
• Source: Instituto do Cancer do Estado de São Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: April 15, 2017
• Est. primary completion date: February 15, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Atelectasis
• Hypertension
• Lung Edema
• Pulmonary Atelectasis

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Instituto do Cancer do Estado de São Paulo

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hyperdistension	We acquire lung ultrasound images during tritiating peep and analyze if any patient have hyperdistension	during tritiate peep
Secondary	Atelectasis	After the procedure we analyze with patient group have more atelectasis	in the final of the procedure