Pulmonary Evaluation With Ultrasound in Different Levels of PEEP

NCT03211936 | Completed DMC

• 1 other identifier: NP 807/15
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Atelectasis; Hypertension; Lung Edema

Outcome Measures

Primary Outcomes (1)

• Hyperdistension

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

  during tritiate peep

Secondary Outcomes (1)

• Atelectasis

  in the final of the procedure

Study Arms (2)

PEEP 4

ACTIVE COMPARATOR

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; Device: Use ultrasound; Device: Impedance tomography; Other: PEEP 4

PEEP TITRATED

EXPERIMENTAL

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; Device: Use ultrasound; Device: Impedance tomography; Other: Best PEEP for less collapse

Interventions

PEEP TITRATED PROCEDURE

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

PEEP 4; PEEP TITRATED

Use ultrasound DEVICE

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

PEEP 4; PEEP TITRATED

Impedance tomography DEVICE

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

PEEP 4; PEEP TITRATED

Best PEEP for less collapse OTHER

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

PEEP TITRATED

PEEP 4 OTHER

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

PEEP 4

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

Sponsors & Collaborators

• Instituto do Cancer do Estado de São Paulo: lead

MeSH Terms

Conditions

Pulmonary Atelectasis; Hypertension; Pulmonary Edema

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Maria Jose Carmona, PhD

  University of Sao Paulo

  STUDY CHAIR

• Claudia Simões, PhD

  Universiadde de São Paulo/ ICESP

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2017
• First Posted: July 11, 2017
• Study Start: December 15, 2015
• Primary Completion: February 15, 2017
• Study Completion: April 15, 2017
• Last Updated: September 20, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share