AtelectasisEVALUSNCT03211936
Pulmonary Evaluation With Ultrasound in Different Levels of PEEP
A study testing PEEP TITRATED, Use ultrasound and Impedance tomography in people with Atelectasis and Hypertension, run by Instituto do Cancer do Estado de São Paulo.
Trial summary
Patients submitted to general anesthesia and artificial ventilation almost always develop pulmonary atelectasis, which can determine adverse consequences both intraoperatively and postoperatively. Read more about this study
- Who is it for?
- Ages 30 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Atelectasis, Hypertension, Lung Edema
- What is being tested?
- PEEP TITRATED, Use ultrasound and Impedance tomography
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 15 Dec 2015to 15 Apr 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
About this study
Official title: Pulmonary Evaluation at Different Levels of PEEP: Ultrasonography Compared to Electrical Impedance Tomography (TIE) During Intraoperative Elective Surgeries
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
- Being tested
- PEEP TITRATED, Use ultrasound, Impedance tomography, Best PEEP for less collapse, PEEP 4
- Medical subject headings
- Pulmonary Atelectasis, Hypertension, Pulmonary Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEEP TITRATEDProcedure or surgery
After titrated peep levels, we choice this level of peep for de group (peep titrated)
Use ultrasoundDevice
We make a lung ultrasound after we setup a different level of PEEP
Impedance tomographyDevice
We use the impedance tomography to titrate peep levels, and acquire dates of collapse, hyperdistension and compliance.
Best PEEP for less collapseOther
After titrated PEEP levels we setup the best PEEP the according of tomography impedance
PEEP 4Other
We set the peep level after titrated peep = 4 cmH20.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Procedure: PEEP TITRATED; Device: Use ultrasound; Device: Impedance tomography; Other: Best PEEP for less collapse |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hyperdistension
We acquire lung ultrasound images during tritiating peep and analyze if any patient have hyperdistension
Measured: during tritiate peep
Secondary outcomes (1)
Atelectasis
After the procedure we analyze with patient group have more atelectasis
Measured: in the final of the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2017
- Study start15 Dec 2015
- Primary completion15 Feb 2017
- Study completion15 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AtelectasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto do Cancer do Estado de São Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maria Jose Carmona, PhD, Study chair, University of Sao PauloClaudia Simões, PhD, Study director, Universiadde de São Paulo/ ICESP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03211936
- Sponsor's protocol ID
- NP 807/15
- Acronym
- EVALUS
- Status last verified
- Sep 2017
- First submitted
- 20 Apr 2017
- Last updated
- 20 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulmonary Evaluation at Different Levels of PEEP: Ultrasonography Compared to Electrical Impedance Tomography (TIE) During Intraoperative Elective Surgeries
- ClinicalTrials.gov ID
- NCT03211936
- Acronym / sponsor ID
- EVALUS / NP 807/15
- Conditions
- Atelectasis, Hypertension, Lung Edema
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Instituto do Cancer do Estado de São PauloUniversity, hospital or other
- Study start
- 15 Dec 2015 (actual)
- Primary completion
- 15 Feb 2017 (actual)
- Study completion
- 15 Apr 2017 (actual)
- First posted
- 11 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PEEP 4 | Active comparator | Procedure: PEEP TITRATED, Device: Use ultrasound, Device: Impedance tomography, Other: PEEP 4We 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 |
| PEEP TITRATED | Experimental | Procedure: PEEP TITRATED, Device: Use ultrasound, Device: Impedance tomography, Other: Best PEEP for less collapseWe 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 |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PEEP TITRATEDAfter titrated peep levels, we choice this level of peep for de group (peep titrated) | Procedure or surgery | PEEP 4, PEEP TITRATED |
| Use ultrasoundWe make a lung ultrasound after we setup a different level of PEEP | Device | PEEP 4, PEEP TITRATED |
| Impedance tomographyWe use the impedance tomography to titrate peep levels, and acquire dates of collapse, hyperdistension and compliance. | Device | PEEP 4, PEEP TITRATED |
| Best PEEP for less collapseAfter titrated PEEP levels we setup the best PEEP the according of tomography impedance | Other | PEEP TITRATED |
| PEEP 4We set the peep level after titrated peep = 4 cmH20. | Other | PEEP 4 |
Primary outcome
Hyperdistension
Time frame: during tritiate peep
We acquire lung ultrasound images during tritiating peep and analyze if any patient have hyperdistension
1 secondary outcome
Atelectasis
Time frame: in the final of the procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2017.
- Individual participant dataSharing planned: No
Related trials for Atelectasis
Recruiting
Comparing Surfactant Administration Through Supraglottic Airway and Thin Catheter for Preterm Infants
Surfactant, Respiratory Distress Syndrome (Neonatal)
Active, not recruiting
Stepwise PEEP vs Sustained Inflation in Bariatric Surgery Patients
Recruitment, Bariatric Surgery Candidate
Not yet recruiting
Bedside Assessment of Right Ventricular Output Lying in Prone Or Supine
Right Ventricular Function, Prone Position
Recruiting
Bronchoscopic Airway Clearance for Improving Lung Aeration in Mechanically Ventilated Patients With Atelectasis
Atelectasis, Mechanical Ventilation
Not yet recruitingObservational study
Chest Ultrasound as Diagnostic and Prognostic Tool in Neonatal RDS
Respiratory Distress Syndrome, Newborn, Neonatal Respiratory Distress
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria Jose Carmona, PhD study chair
University of Sao Paulo
Claudia Simões, PhD study director
Universiadde de São Paulo/ ICESP
Questions about this trial
What is this clinical trial studying?
A study testing PEEP TITRATED, Use ultrasound and Impedance tomography in people with Atelectasis and Hypertension, run by Instituto do Cancer do Estado de São Paulo.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hyperdistension (time frame: during tritiate peep). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2017.