EVALUS: Pulmonary Evaluation With Ultrasound in Different Levels of PEEP

Sponsor
Instituto do Cancer do Estado de São Paulo (Other)
Overall Status
Completed
CT.gov ID
NCT03211936
Collaborator
(none)
40
2
16

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: PEEP TITRATED
  • Device: Use ultrasound
  • Device: Impedance tomography
  • Other: Best PEEP for less collapse
  • Other: PEEP 4
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Care Provider)
Primary Purpose:
Diagnostic
Official Title:
Pulmonary Evaluation at Different Levels of PEEP: Ultrasonography Compared to Electrical Impedance Tomography (TIE) During Intraoperative Elective Surgeries
Actual Study Start Date :
Dec 15, 2015
Actual Primary Completion Date :
Feb 15, 2017
Actual Study Completion Date :
Apr 15, 2017

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Hyperdistension [during tritiate peep]

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

Secondary Outcome Measures

  1. Atelectasis [in the final of the procedure]

    After the procedure we analyze with patient group have more atelectasis

Eligibility Criteria

Criteria

Ages Eligible for Study:
30 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Instituto do Cancer do Estado de São Paulo
ClinicalTrials.gov Identifier:
NCT03211936
Other Study ID Numbers:
  • NP 807/15
First Posted:
Jul 11, 2017
Last Update Posted:
Sep 20, 2017
Last Verified:
Sep 1, 2017
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 20, 2017