Pulmonary AtelectasisNCT02314845
Optimizing Intraoperative Mechanical Ventilation Using EIT-titrated PEEP
A study testing Optimal PEEP and Low PEEP in people with Pulmonary Atelectasis, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial summary
The purpose of this randomized single center study is to determine the individual PEEP value that produces the best possible compromise of lung collapse and lung hyperdistention. Patients submitted to general anesthesia and mechanical ventilation during surgery (laparoscopy and open surgery) will participate. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Atelectasis
- What is being tested?
- Optimal PEEP and Low PEEP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- Aug 2014to Apr 2016
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients submitted to general anesthesia for surgical procedure
Who cannot join
- Age < 18 years
- Thoracic surgery (any)
- ASA grade III or IV
- History of moderate/severe chronic obstructive pulmonary disease (COPD) or moderate/severe Asthma
- Moderate/severe restrictive lung disease
- Use of heart pacemaker
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this randomized single center study is to determine the individual PEEP value that produces the best possible compromise of lung collapse and lung hyperdistention. Patients submitted to general anesthesia and mechanical ventilation during surgery (laparoscopy and open surgery) will participate. A PEEP titration procedure will be performed and the "optimal PEEP" value will be determined by electrical impedance tomography (EIT). An ultrasound will be used to record each step of the PEEP titration procedure in a sub-sample of patients. A total of 40 patients will be mechanically ventilated using physiological tidal volume (TV=6mL/kg of IBW) and fraction of inspired oxygen (FIO2) of 0.5 and will be randomized to one of two groups: "optimal PEEP" or a "low PEEP" (4cmH2O). Lung collapse and mechanics will be monitored by EIT throughout the intraoperative period. After extubation, a lung CT will be performed to evaluate the amount of lung collapse.
Read the detailed description
Patients submitted to general anesthesia and mechanical ventilation commonly develop pulmonary atelectasis, which can cause adverse consequences either intraoperatively or postoperatively. The use of lower, more physiological tidal volumes (6-8 mL/Kg of ideal body weight) during the intraoperative period can minimize the risk of lung injury but may be associated with increased atelectasis. The application of PEEP can prevent the formation of atelectasis and minimize the resulting complications, but at the present time, there is no consensus on how to tailor the level of PEEP to best suit each patient.
Electrical Impedance Tomography (EIT) is a portable non-invasive monitor that enables the analysis of lung function in a continuous mode.
The aim of this study is to evaluate the use of Electrical Impedance Tomography (EIT), in the intraoperative period, as a tool for selecting "optimal PEEP" using a PEEP titration procedure, as well as assessing the evolution of pulmonary function during this period.
The investigators will prospectively study a total of 40 adult patients (> 18 years) divided into two subgroups: 20 laparoscopic surgery patients and 20 open surgery patients. After induction of anesthesia and neuromuscular blockade, all patients will be submitted to a recruitment maneuver in pressure-controlled ventilation (PCV) mode (PEEP = 20cmH2O, driving pressure = 20cmH2O, respiratory rate (RR) of 15 ipm and I:E ratio of 1:1) for 2 minutes followed by a decremental PEEP titration. The first step of the titration will start at a PEEP of 20 cmH2O and every 40 seconds PEEP will be decreased by 2 cmH2O, until a final PEEP of 4 cmH2O. A sub-sample of patients will have each step of the PEEP titration procedure recorded with an ultrasound and later evaluated by two different investigators. Optimal PEEP will be defined as that with the best compromise of atelectasis and overdistension as measured by EIT.
Patients in each subgroup will be randomized to one of two ventilatory strategies: (1) PEEP chosen by the PEEP titration procedure; (2) PEEP set at 4 cmH2O. After a new recruitment maneuver PEEP will be set at the designated value and the patient will be ventilated with an inspired oxygen fraction of 50% or greater in order to maintain peripheral oxygen saturation (SpO2) > 96%, a tidal volume of 6 mL/Kg and a respiratory rate to maintain an end tidal carbon dioxide (ETCO2) between 35-45.
All patients will have their global and regional pulmonary mechanics monitored by EIT throughout the anesthetic procedure to assess the degree of pulmonary atelectasis. After extubation, patients will be referred to the Radiology Department for a chest CT.
- Conditions
- Pulmonary Atelectasis
- Being tested
- Optimal PEEP, Low PEEP
- Keywords
- Pulmonary Atelectasis, Pulmonary Ventilation, Anesthesia, General, Electric Impedance, Tomography, Spiral Computed, Intraoperative Period
- Medical subject headings
- Pulmonary Atelectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optimal PEEPOther
"Optimal PEEP" determined by EIT during a PEEP titration procedure.
Low PEEPOther
Use of PEEP of 4 cmH2O during intraoperative period
| Study group | Role | What they receive |
|---|---|---|
| Optimal PEEP | Experimental | Patients submitted to general anesthesia and abdominal laparoscopic surgery (number=10) or open surgery (number=10) will be submitted to a recruitment maneuver followed by a PEEP titration procedure using Electrical Impedance Tomography (EIT). Patients will be mechanically ventilated during intraoperative period using "Optimal PEEP" determined by Electrical Impedance and FIO2 of 0.5. Receives: Other: Optimal PEEP |
| Low PEEP | Other | Patients submitted to general anesthesia and abdominal laparoscopic surgery (number=10) or open surgery (number=10) will be submitted to a recruitment maneuver followed by a PEEP titration procedure EIT. In this arm, the ventilator will be set with a PEEP=4 cmH2O ("Low PEEP") and FIO2 of 0.5 during intraoperative period. Receives: Other: Low PEEP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Optimal PEEP value
The PEEP value, for each patient, that produces the best possible compromise of lung collapse and lung hyperdistention during a PEEP titration procedure using EIT
Measured: 6 minutes
Secondary outcomes (2)
Pulmonary atelectasis
The amount of atelectasis, in percentage of lung mass, evaluated by EIT during intraoperative period and by chest CT scan after extubation
Measured: 2-5 hours
Ultrasound evaluation
The use of ultrasound as a tool for PEEP titration intraoperatively compared to EIT
Measured: 6 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2014 (estimated)
- Study startAug 2014
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pulmonary 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Responsible party
- Principal investigator, Joaquim Edson Vieira, University of Sao Paulo General Hospital
- Investigators
- Joaquim E Vieira, MD, PhD, Principal investigator, University of Sao Paulo General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02314845
- Sponsor's protocol ID
- CAAE_13768713.0.0000.0068
- Status last verified
- May 2016
- First submitted
- 7 Nov 2014
- Last updated
- 12 May 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Tonelotto B, Pereira SM, Tucci MR, Vaz DF, Vieira JE, Malbouisson LM, Gay F, Simoes CM, Carvalho Carmona MJ, Monsel A, Amato MB, Rouby JJ, Costa Auler JO Jr. Intraoperative pulmonary hyperdistention estimated by transthoracic lung ultrasound: A pilot study. Anaesth Crit Care Pain Med. 2020 Dec;39(6):825-831. doi: 10.1016/j.accpm.2020.09.009. Epub 2020 Oct 17.
PubMed 33080407Pereira SM, Tucci MR, Morais CCA, Simoes CM, Tonelotto BFF, Pompeo MS, Kay FU, Pelosi P, Vieira JE, Amato MBP. Individual Positive End-expiratory Pressure Settings Optimize Intraoperative Mechanical Ventilation and Reduce Postoperative Atelectasis. Anesthesiology. 2018 Dec;129(6):1070-1081. doi: 10.1097/ALN.0000000000002435.
PubMed 30260897
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Intraoperative Mechanical Ventilation Using EIT-titrated PEEP
- ClinicalTrials.gov ID
- NCT02314845
- Acronym / sponsor ID
- CAAE_13768713.0.0000.0068
- Conditions
- Pulmonary Atelectasis
- Keywords
- Pulmonary Atelectasis, Pulmonary Ventilation, Anesthesia, General, Electric Impedance, Tomography, Spiral Computed, Intraoperative Period
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- Aug 2014
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 11 Dec 2014 (estimated)
- 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.
The purpose of this randomized single center study is to determine the individual PEEP value that produces the best possible compromise of lung collapse and lung hyperdistention. Patients submitted to general anesthesia and mechanical ventilation during surgery (laparoscopy and open surgery) will participate. A PEEP titration procedure will be performed and the "optimal PEEP" value will be determined by electrical impedance tomography (EIT). An ultrasound will be used to record each step of the PEEP titration procedure in a sub-sample of patients. A total of 40 patients will be mechanically ventilated using physiological tidal volume (TV=6mL/kg of IBW) and fraction of inspired oxygen (FIO2) of 0.5 and will be randomized to one of two groups: "optimal PEEP" or a "low PEEP" (4cmH2O). Lung collapse and mechanics will be monitored by EIT throughout the intraoperative period. After extubation, a lung CT will be performed to evaluate the amount of lung collapse.
Detailed description
Patients submitted to general anesthesia and mechanical ventilation commonly develop pulmonary atelectasis, which can cause adverse consequences either intraoperatively or postoperatively. The use of lower, more physiological tidal volumes (6-8 mL/Kg of ideal body weight) during the intraoperative period can minimize the risk of lung injury but may be associated with increased atelectasis. The application of PEEP can prevent the formation of atelectasis and minimize the resulting complications, but at the present time, there is no consensus on how to tailor the level of PEEP to best suit each patient.
Electrical Impedance Tomography (EIT) is a portable non-invasive monitor that enables the analysis of lung function in a continuous mode.
The aim of this study is to evaluate the use of Electrical Impedance Tomography (EIT), in the intraoperative period, as a tool for selecting "optimal PEEP" using a PEEP titration procedure, as well as assessing the evolution of pulmonary function during this period.
The investigators will prospectively study a total of 40 adult patients (> 18 years) divided into two subgroups: 20 laparoscopic surgery patients and 20 open surgery patients. After induction of anesthesia and neuromuscular blockade, all patients will be submitted to a recruitment maneuver in pressure-controlled ventilation (PCV) mode (PEEP = 20cmH2O, driving pressure = 20cmH2O, respiratory rate (RR) of 15 ipm and I:E ratio of 1:1) for 2 minutes followed by a decremental PEEP titration. The first step of the titration will start at a PEEP of 20 cmH2O and every 40 seconds PEEP will be decreased by 2 cmH2O, until a final PEEP of 4 cmH2O. A sub-sample of patients will have each step of the PEEP titration procedure recorded with an ultrasound and later evaluated by two different investigators. Optimal PEEP will be defined as that with the best compromise of atelectasis and overdistension as measured by EIT.
Patients in each subgroup will be randomized to one of two ventilatory strategies: (1) PEEP chosen by the PEEP titration procedure; (2) PEEP set at 4 cmH2O. After a new recruitment maneuver PEEP will be set at the designated value and the patient will be ventilated with an inspired oxygen fraction of 50% or greater in order to maintain peripheral oxygen saturation (SpO2) > 96%, a tidal volume of 6 mL/Kg and a respiratory rate to maintain an end tidal carbon dioxide (ETCO2) between 35-45.
All patients will have their global and regional pulmonary mechanics monitored by EIT throughout the anesthetic procedure to assess the degree of pulmonary atelectasis. After extubation, patients will be referred to the Radiology Department for a chest CT.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Optimal PEEP | Experimental | Other: Optimal PEEPPatients submitted to general anesthesia and abdominal laparoscopic surgery (number=10) or open surgery (number=10) will be submitted to a recruitment maneuver followed by a PEEP titration procedure using Electrical Impedance Tomography (EIT). Patients will be mechanically ventilated during intraoperative period using "Optimal PEEP" determined by Electrical Impedance and FIO2 of 0.5. |
| Low PEEP | Other | Other: Low PEEPPatients submitted to general anesthesia and abdominal laparoscopic surgery (number=10) or open surgery (number=10) will be submitted to a recruitment maneuver followed by a PEEP titration procedure EIT. In this arm, the ventilator will be set with a PEEP=4 cmH2O ("Low PEEP") and FIO2 of 0.5 during intraoperative period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients submitted to general anesthesia for surgical procedure
Key exclusion criteria (6 listed)
- Age < 18 years
- Thoracic surgery (any)
- ASA grade III or IV
- History of moderate/severe chronic obstructive pulmonary disease (COPD) or moderate/severe Asthma
- Moderate/severe restrictive lung disease
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 |
|---|---|---|
| Optimal PEEP"Optimal PEEP" determined by EIT during a PEEP titration procedure. | Other | Optimal PEEP |
| Low PEEPUse of PEEP of 4 cmH2O during intraoperative period | Other | Low PEEP |
Primary outcome
Optimal PEEP value
Time frame: 6 minutes
The PEEP value, for each patient, that produces the best possible compromise of lung collapse and lung hyperdistention during a PEEP titration procedure using EIT
2 secondary outcomes
Pulmonary atelectasis
Time frame: 2-5 hours
Ultrasound evaluation
Time frame: 6 minutes
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 12 May 2016.
- Derived from this study: PubMed 33080407Tonelotto B, Pereira SM, Tucci MR, Vaz DF, Vieira JE, Malbouisson LM, Gay F, Simoes CM, Carvalho Carmona MJ, Monsel A, Amato MB, Rouby JJ, Costa Auler JO Jr. Intraoperative pulmonary hyperdistention estimated by transthoracic lung ultrasound: A pilot study. Anaesth Crit Care Pain Med. 2020 Dec;39(6):825-831. doi: 10.1016/j.accpm.2020.09.009. Epub 2020 Oct 17.
- Derived from this study: PubMed 30260897Pereira SM, Tucci MR, Morais CCA, Simoes CM, Tonelotto BFF, Pompeo MS, Kay FU, Pelosi P, Vieira JE, Amato MBP. Individual Positive End-expiratory Pressure Settings Optimize Intraoperative Mechanical Ventilation and Reduce Postoperative Atelectasis. Anesthesiology. 2018 Dec;129(6):1070-1081. doi: 10.1097/ALN.0000000000002435.
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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.
Joaquim E Vieira, MD, PhD principal investigator
University of Sao Paulo General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Optimal PEEP and Low PEEP in people with Pulmonary Atelectasis, run by University of Sao Paulo General Hospital at 1 site in Brazil.
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 6 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 12 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Optimal PEEP value (time frame: 6 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02314845, which also lists 2 linked publications.
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 12 May 2016.