Postpartum PeriodCOSIPBEITNCT03715647
Correlation of Survival in Puerperae by Electrical Impedance Tomography
An observational study of Postpartum Period and Sepsis, run by Amazon University.
Trial summary
Introduction: Electrical Impedance Tomography (TIE) consists of an equipment that enables the visualization / quantification in real time of the regional distribution of ventilation and pulmonary perfusion, as well as of ventilatory mechanics. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Postpartum Period, Sepsis, Respiratory Distress Syndrome,Adult
- What is being tested?
- Sepsis, HELLP Syndrome and Respiratory Distress Syndrome Adult
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Jan 2017to Jun 2018
- Phase
- Observational
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: The sample of this research will be constituted by puerperas hospitalized in the adult ICU of the FSCMP from September 2017 to May 2018, and evolved with the diagnosis of ARDS, HELLP syndrome or sepsis, being sedated and requiring invasive mechanical ventilation in the assisted mode -controlled during his period of hospitalization.
Who may be able to join
- To be admitted to the Adult Intensive Care Unit (ICU) of the FSCMP;
- Being in the postpartum/puerperium period;
- To evolve with complications of its clinical condition: sepsis with pulmonary repercussions, Specific Disease of Pregnancy (SDP), HELLP syndrome or ARDS;
- Support by invasive mechanical ventilation;
- To be previously authorized by the family to participate in the study through the WICF.
Who cannot join
- Being a cardiac pacemaker;
- Pregnant women in any period of gestation who develop complications of their clinical condition and need support through invasive ventilation.
About this study
Official title: Correlation of the Driving Pressure With the Survival of Puerperae Under Mechanical Ventilation by Electrical Impedance Tomography
Introduction: Electrical Impedance Tomography (TIE) consists of an equipment that enables the visualization / quantification in real time of the regional distribution of ventilation and pulmonary perfusion, as well as of ventilatory mechanics. Used on the edge of the bed, it is easy to move, non-invasive, allowing a momentary or continuous assessment, guiding the conduct in a safe and precise way through the electrical impedance technology. It is important to note that, in addition to ensuring the efficacy of the patient's behavior, the TIE supports the most diverse types of studies to be performed. These include those based on the effectiveness of the use of the method in the most diverse pulmonary dysfunctions, in the adjustment of the mechanical ventilation and in the average time of hospitalization. Objective: To evaluate the pulmonary function of patients in invasive mechanical ventilation through SIT. Method: This research was carried out in compliance with the National Health Council's Guidelines for Research Involving Human Beings (466/12). The study was a prospective longitudinal clinical-experimental type in which all patients (occasional sampling) used mechanical ventilation and were hospitalized in the Adult Intensive Care Unit (ICU) of the Santa Casa de Misericórdia Foundation of Pará, and they developed sepsis with pulmonary repercussions; (DEHG) / HELLP Syndrome and Adult Respiratory Distress Syndrome (ARDS) and who met the inclusion criteria were evaluated and monitored with TIE to perform ventilatory therapy according to the research objectives. The research was carried out in the city of Belém, in the state of Pará, in the adult ICU of the FSCMP. As inclusion criterion, the patient should be in the FSCMP adult Intensive Care Unit (ICU), under mechanical invasive ventilation, previously authorized by the family through the Informed Consent Form to participate in the study.
Read the detailed description
A prospective longitudinal clinical-experimental study was carried out in which 30 postpartum / postpartum women who developed complications of their clinical condition, needing support by invasive mechanical ventilation, development of sepsis with pulmonary repercussion, Specific Pregnancy Disease ( SDP), HELLP syndrome or ARDS were evaluated and monitored with Electrical Impedance Tomography for conduction of ventilatory therapy. In order to obtain the images and quantification of the regional ventilatory distribution, two tapes with 16 electrodes were connected by means of an adhesive tape, one for each band, around the thorax and aligned in a plane corresponding to a cross section with emission of an electric current imperceptible and harmless to the patient, generating, according to the pulmonary dynamics, a variation of electrical impedance, consequently a gradient of electrical resistivity. A flow sensor positioned between the endotracheal tube and the "Y" of the ventilator circuit, responsible for capturing ventilatory mechanic information, and a reference cable positioned by an electrocardiographic monitoring electrode, in the abdominal region or in the region from the shoulders. The data were sent simultaneously to a system (computer) with specific softwear in order to measure and quantify the regional distribution of pulmonary ventilation and perfusion, as well as its correlation in patients under mechanical ventilation. All experimental values were presented as mean ± standard deviation (SD). The study was of the experimental type, and the descriptive statistic was used to characterize the sample. Statistical analysis was performed with GraphPad Prism 5.0. The P value <0.05 was considered statistically significant. The results were placed in spreadsheets and graphs created with GraphPad Prism 5.0 (GraphPad Software, San Diego, California, USA).
- Being tested
- Sepsis, HELLP Syndrome, Respiratory Distress Syndrome Adult
- Medical subject headings
- Sepsis, Respiratory Distress Syndrome, HELLP Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SepsisOther
Evaluation and monitoring with Electrical Impedance Tomography in order to conduct ventilatory therapy.
HELLP SyndromeOther
Evaluation and monitoring with Electrical Impedance Tomography in order to conduct ventilatory therapy.
Respiratory Distress Syndrome AdultOther
Evaluation and monitoring with Electrical Impedance Tomography in order to conduct ventilatory therapy.
| Study group | Role | What they receive |
|---|---|---|
| Sepsis | The puerperal / postpartum women who evolved with sepsis, needing support by invasive mechanical ventilation, were evaluated and monitored with Electrical Impedance Tomography for ventilatory therapy. In order to obtain the images and quantification of the regional ventilatory distribution, two strips with 16 electrodes were connected around the thorax to capture an imperceptible and harmless electric current to the patient, generating, according to the pulmonary dynamics, an impedance power of variation. A flow sensor was positioned between the endotracheal tube and the "Y" of the ventilator circuit and was responsible for capturing information about ventilatory mechanics. Data were sent simultaneously to a system (computer) with specific softwear in order to measure and quantify the regional distribution of pulmonary ventilation and perfusion, as well as their correlation. Receives: Other: Sepsis | |
| HELLP Syndrome | The puerperal / postpartum women who evolved with HELLP syndrome, needing support by invasive mechanical ventilation, were evaluated and monitored with Electrical Impedance Tomography for ventilatory therapy. In order to obtain the images and quantification of the regional ventilatory distribution, two strips with 16 electrodes were connected around the thorax to capture an imperceptible and harmless electric current to the patient, generating, according to the pulmonary dynamics, an impedance power of variation. A flow sensor was positioned between the endotracheal tube and the "Y" of the ventilator circuit and was responsible for capturing information about ventilatory mechanics. Data were sent simultaneously to a system (computer) with specific softwear in order to measure and quantify the regional distribution of pulmonary ventilation and perfusion, as well as their correlation. Receives: Other: HELLP Syndrome | |
| Respiratory Distress Syndrome, Adult | The puerperal / postpartum women who evolved with Adult Respiratory Distress Syndrome, needing support by invasive mechanical ventilation, were evaluated and monitored with Electrical Impedance Tomography for ventilatory therapy. In order to obtain the images and quantification of the regional ventilatory distribution, two strips with 16 electrodes were connected around the thorax to capture an imperceptible and harmless electric current to the patient, generating, according to the pulmonary dynamics, an impedance power of variation. A flow sensor was positioned between the endotracheal tube and the "Y" of the ventilator circuit and was responsible for capturing information about ventilatory mechanics. Data were sent simultaneously to a system (computer) with specific softwear in order to measure and quantify the regional distribution of pulmonary ventilation and perfusion, as well as their correlation. Receives: Other: Respiratory Distress Syndrome Adult |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation of the driving pressure with the survival of puerperae under mechanical ventilation by electrical impedance tomography
For the delimitation of the information collection of postpartum women submitted to invasive mechanical ventilation for having evolved with HELLP syndrome, sepsis or respiratory distress syndrome, and ventilatory data were collected from the data sheet of the Electrical Impedance Tomography, containing data from the regional distribution of (Cst) of the respiratory system, final expiratory positive pressure (PEEP) and Platelet Pressure (Pplatô), as well as ventilatory parameters data: Ventilatory mode and mode, PEEP, VT, Inspiratory Time (I), Inspired Fraction of Oxygen (FiO2), Sensitivity (Sens.), Of hospitalized patients in the period of collections. After a retrospective survey of the sample, data were collected from patients who were in the Intensive Care Unit, while they were on invasive mechanical ventilation and monitored by Electrical Impedance Tomography.
Measured: Data will be collected 3 times a day in the morning, evening and evening hours until the conclusion of the study, with a mean of 3 to 5 days of monitoring by electrical impedance tomography
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2018
- Study startJan 2017
- Primary completionDec 2017
- Study completionJun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Postpartum PeriodStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amazon University
- Sponsor type
- University, hospital or other
- Collaborators
- Santa Casa de Misericórdia do Pará
- Responsible party
- Principal investigator, Paulo Eduardo Santos Avila, Amazon University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03715647
- Sponsor's protocol ID
- 2.251.640
- Acronym
- COSIPBEIT
- Status last verified
- Nov 2018
- First submitted
- 25 Jul 2018
- Last updated
- 6 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Amato MB, Meade MO, Slutsky AS, Brochard L, Costa EL, Schoenfeld DA, Stewart TE, Briel M, Talmor D, Mercat A, Richard JC, Carvalho CR, Brower RG. Driving pressure and survival in the acute respiratory distress syndrome. N Engl J Med. 2015 Feb 19;372(8):747-55. doi: 10.1056/NEJMsa1410639.
PubMed 25693014Bellani G, Laffey JG, Pham T, Fan E, Brochard L, Esteban A, Gattinoni L, van Haren F, Larsson A, McAuley DF, Ranieri M, Rubenfeld G, Thompson BT, Wrigge H, Slutsky AS, Pesenti A; LUNG SAFE Investigators; ESICM Trials Group. Epidemiology, Patterns of Care, and Mortality for Patients With Acute Respiratory Distress Syndrome in Intensive Care Units in 50 Countries. JAMA. 2016 Feb 23;315(8):788-800. doi: 10.1001/jama.2016.0291.
PubMed 26903337Brenner DJ. Radiation risks potentially associated with low-dose CT screening of adult smokers for lung cancer. Radiology. 2004 May;231(2):440-5. doi: 10.1148/radiol.2312030880.
PubMed 15128988Cinnella G, Grasso S, Raimondo P, D'Antini D, Mirabella L, Rauseo M, Dambrosio M. Physiological Effects of the Open Lung Approach in Patients with Early, Mild, Diffuse Acute Respiratory Distress Syndrome: An Electrical Impedance Tomography Study. Anesthesiology. 2015 Nov;123(5):1113-21. doi: 10.1097/ALN.0000000000000862.
PubMed 26397017Costa EL, Borges JB, Melo A, Suarez-Sipmann F, Toufen C Jr, Bohm SH, Amato MB. Bedside estimation of recruitable alveolar collapse and hyperdistension by electrical impedance tomography. Intensive Care Med. 2009 Jun;35(6):1132-7. doi: 10.1007/s00134-009-1447-y. Epub 2009 Mar 3.
PubMed 19255741Frerichs I, Hinz J, Herrmann P, Weisser G, Hahn G, Dudykevych T, Quintel M, Hellige G. Detection of local lung air content by electrical impedance tomography compared with electron beam CT. J Appl Physiol (1985). 2002 Aug;93(2):660-6. doi: 10.1152/japplphysiol.00081.2002.
PubMed 12133877Frerichs I, Dargaville PA, Dudykevych T, Rimensberger PC. Electrical impedance tomography: a method for monitoring regional lung aeration and tidal volume distribution? Intensive Care Med. 2003 Dec;29(12):2312-2316. doi: 10.1007/s00134-003-2029-z. Epub 2003 Oct 18.
PubMed 14566457Jubran A. Advances in respiratory monitoring during mechanical ventilation. Chest. 1999 Nov;116(5):1416-25. doi: 10.1378/chest.116.5.1416.
PubMed 10559107Matthay MA, Zemans RL. The acute respiratory distress syndrome: pathogenesis and treatment. Annu Rev Pathol. 2011;6:147-63. doi: 10.1146/annurev-pathol-011110-130158.
PubMed 20936936Neto AS, Hemmes SN, Barbas CS, Beiderlinden M, Fernandez-Bustamante A, Futier E, Gajic O, El-Tahan MR, Ghamdi AA, Gunay E, Jaber S, Kokulu S, Kozian A, Licker M, Lin WQ, Maslow AD, Memtsoudis SG, Reis Miranda D, Moine P, Ng T, Paparella D, Ranieri VM, Scavonetto F, Schilling T, Selmo G, Severgnini P, Sprung J, Sundar S, Talmor D, Treschan T, Unzueta C, Weingarten TN, Wolthuis EK, Wrigge H, Amato MB, Costa EL, de Abreu MG, Pelosi P, Schultz MJ; PROVE Network Investigators. Association between driving pressure and development of postoperative pulmonary complications in patients undergoing mechanical ventilation for general anaesthesia: a meta-analysis of individual patient data. Lancet Respir Med. 2016 Apr;4(4):272-80. doi: 10.1016/S2213-2600(16)00057-6. Epub 2016 Mar 4.
PubMed 26947624Pearce MS, Salotti JA, Little MP, McHugh K, Lee C, Kim KP, Howe NL, Ronckers CM, Rajaraman P, Sir Craft AW, Parker L, Berrington de Gonzalez A. Radiation exposure from CT scans in childhood and subsequent risk of leukaemia and brain tumours: a retrospective cohort study. Lancet. 2012 Aug 4;380(9840):499-505. doi: 10.1016/S0140-6736(12)60815-0. Epub 2012 Jun 7.
PubMed 22681860Pesenti A, Musch G, Lichtenstein D, Mojoli F, Amato MBP, Cinnella G, Gattinoni L, Quintel M. Imaging in acute respiratory distress syndrome. Intensive Care Med. 2016 May;42(5):686-698. doi: 10.1007/s00134-016-4328-1. Epub 2016 Mar 31.
PubMed 27033882Reinius H, Borges JB, Freden F, Jideus L, Camargo ED, Amato MB, Hedenstierna G, Larsson A, Lennmyr F. Real-time ventilation and perfusion distributions by electrical impedance tomography during one-lung ventilation with capnothorax. Acta Anaesthesiol Scand. 2015 Mar;59(3):354-68. doi: 10.1111/aas.12455. Epub 2015 Jan 5.
PubMed 25556329
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation of the Driving Pressure With the Survival of Puerperae Under Mechanical Ventilation by Electrical Impedance Tomography
- ClinicalTrials.gov ID
- NCT03715647
- Acronym / sponsor ID
- COSIPBEIT / 2.251.640
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Amazon UniversityUniversity, hospital or other
- Collaborators
- Santa Casa de Misericórdia do Pará
- Study start
- Jan 2017 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 23 Oct 2018 (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.
Introduction: Electrical Impedance Tomography (TIE) consists of an equipment that enables the visualization / quantification in real time of the regional distribution of ventilation and pulmonary perfusion, as well as of ventilatory mechanics. Used on the edge of the bed, it is easy to move, non-invasive, allowing a momentary or continuous assessment, guiding the conduct in a safe and precise way through the electrical impedance technology. It is important to note that, in addition to ensuring the efficacy of the patient's behavior, the TIE supports the most diverse types of studies to be performed. These include those based on the effectiveness of the use of the method in the most diverse pulmonary dysfunctions, in the adjustment of the mechanical ventilation and in the average time of hospitalization. Objective: To evaluate the pulmonary function of patients in invasive mechanical ventilation through SIT. Method: This research was carried out in compliance with the National Health Council's Guidelines for Research Involving Human Beings (466/12). The study was a prospective longitudinal clinical-experimental type in which all patients (occasional sampling) used mechanical ventilation and were hospitalized in the Adult Intensive Care Unit (ICU) of the Santa Casa de Misericórdia Foundation of Pará, and they developed sepsis with pulmonary repercussions; (DEHG) / HELLP Syndrome and Adult Respiratory Distress Syndrome (ARDS) and who met the inclusion criteria were evaluated and monitored with TIE to perform ventilatory therapy according to the research objectives. The research was carried out in the city of Belém, in the state of Pará, in the adult ICU of the FSCMP. As inclusion criterion, the patient should be in the FSCMP adult Intensive Care Unit (ICU), under mechanical invasive ventilation, previously authorized by the family through the Informed Consent Form to participate in the study.
Detailed description
A prospective longitudinal clinical-experimental study was carried out in which 30 postpartum / postpartum women who developed complications of their clinical condition, needing support by invasive mechanical ventilation, development of sepsis with pulmonary repercussion, Specific Pregnancy Disease ( SDP), HELLP syndrome or ARDS were evaluated and monitored with Electrical Impedance Tomography for conduction of ventilatory therapy. In order to obtain the images and quantification of the regional ventilatory distribution, two tapes with 16 electrodes were connected by means of an adhesive tape, one for each band, around the thorax and aligned in a plane corresponding to a cross section with emission of an electric current imperceptible and harmless to the patient, generating, according to the pulmonary dynamics, a variation of electrical impedance, consequently a gradient of electrical resistivity. A flow sensor positioned between the endotracheal tube and the "Y" of the ventilator circuit, responsible for capturing ventilatory mechanic information, and a reference cable positioned by an electrocardiographic monitoring electrode, in the abdominal region or in the region from the shoulders. The data were sent simultaneously to a system (computer) with specific softwear in order to measure and quantify the regional distribution of pulmonary ventilation and perfusion, as well as its correlation in patients under mechanical ventilation. All experimental values were presented as mean ± standard deviation (SD). The study was of the experimental type, and the descriptive statistic was used to characterize the sample. Statistical analysis was performed with GraphPad Prism 5.0. The P value <0.05 was considered statistically significant. The results were placed in spreadsheets and graphs created with GraphPad Prism 5.0 (GraphPad Software, San Diego, California, USA).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sepsis | – | Other: SepsisThe puerperal / postpartum women who evolved with sepsis, needing support by invasive mechanical ventilation, were evaluated and monitored with Electrical Impedance Tomography for ventilatory therapy. In order to obtain the images and quantification of the regional ventilatory distribution, two strips with 16 electrodes were connected around the thorax to capture an imperceptible and harmless electric current to the patient, generating, according to the pulmonary dynamics, an impedance power of variation. A flow sensor was positioned between the endotracheal tube and the "Y" of the ventilator circuit and was responsible for capturing information about ventilatory mechanics. Data were sent simultaneously to a system (computer) with specific softwear in order to measure and quantify the regional distribution of pulmonary ventilation and perfusion, as well as their correlation. |
| HELLP Syndrome | – | Other: HELLP SyndromeThe puerperal / postpartum women who evolved with HELLP syndrome, needing support by invasive mechanical ventilation, were evaluated and monitored with Electrical Impedance Tomography for ventilatory therapy. In order to obtain the images and quantification of the regional ventilatory distribution, two strips with 16 electrodes were connected around the thorax to capture an imperceptible and harmless electric current to the patient, generating, according to the pulmonary dynamics, an impedance power of variation. A flow sensor was positioned between the endotracheal tube and the "Y" of the ventilator circuit and was responsible for capturing information about ventilatory mechanics. Data were sent simultaneously to a system (computer) with specific softwear in order to measure and quantify the regional distribution of pulmonary ventilation and perfusion, as well as their correlation. |
| Respiratory Distress Syndrome, Adult | – | Other: Respiratory Distress Syndrome AdultThe puerperal / postpartum women who evolved with Adult Respiratory Distress Syndrome, needing support by invasive mechanical ventilation, were evaluated and monitored with Electrical Impedance Tomography for ventilatory therapy. In order to obtain the images and quantification of the regional ventilatory distribution, two strips with 16 electrodes were connected around the thorax to capture an imperceptible and harmless electric current to the patient, generating, according to the pulmonary dynamics, an impedance power of variation. A flow sensor was positioned between the endotracheal tube and the "Y" of the ventilator circuit and was responsible for capturing information about ventilatory mechanics. Data were sent simultaneously to a system (computer) with specific softwear in order to measure and quantify the regional distribution of pulmonary ventilation and perfusion, as well as their correlation. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The sample of this research will be constituted by puerperas hospitalized in the adult ICU of the FSCMP from September 2017 to May 2018, and evolved with the diagnosis of ARDS, HELLP syndrome or sepsis, being sedated and requiring invasive mechanical ventilation in the assisted mode -controlled during his period of hospitalization.
Key inclusion criteria (5 listed)
- To be admitted to the Adult Intensive Care Unit (ICU) of the FSCMP;
- Being in the postpartum/puerperium period;
- To evolve with complications of its clinical condition: sepsis with pulmonary repercussions, Specific Disease of Pregnancy (SDP), HELLP syndrome or ARDS;
- Support by invasive mechanical ventilation;
- To be previously authorized by the family to participate in the study through the WICF.
Key exclusion criteria (2 listed)
- Being a cardiac pacemaker;
- Pregnant women in any period of gestation who develop complications of their clinical condition and need support through invasive ventilation.
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 |
|---|---|---|
| SepsisEvaluation and monitoring with Electrical Impedance Tomography in order to conduct ventilatory therapy. | Other | Sepsis |
| HELLP SyndromeEvaluation and monitoring with Electrical Impedance Tomography in order to conduct ventilatory therapy. | Other | HELLP Syndrome |
| Respiratory Distress Syndrome AdultEvaluation and monitoring with Electrical Impedance Tomography in order to conduct ventilatory therapy. | Other | Respiratory Distress Syndrome, Adult |
Primary outcome
Correlation of the driving pressure with the survival of puerperae under mechanical ventilation by electrical impedance tomography
Time frame: Data will be collected 3 times a day in the morning, evening and evening hours until the conclusion of the study, with a mean of 3 to 5 days of monitoring by electrical impedance tomography
For the delimitation of the information collection of postpartum women submitted to invasive mechanical ventilation for having evolved with HELLP syndrome, sepsis or respiratory distress syndrome, and ventilatory data were collected from the data sheet of the Electrical Impedance Tomography, containing data from the regional distribution of (Cst) of the respiratory system, final expiratory positive pressure (PEEP) and Platelet Pressure (Pplatô), as well as ventilatory parameters data: Ventilatory mode and mode, PEEP, VT, Inspiratory Time (I), Inspired Fraction of Oxygen (FiO2), Sensitivity (Sens.), Of hospitalized patients in the period of collections. After a retrospective survey of the sample, data were collected from patients who were in the Intensive Care Unit, while they were on invasive mechanical ventilation and monitored by Electrical Impedance Tomography.
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 6 Nov 2018.
- Results publication: PubMed 25693014Amato MB, Meade MO, Slutsky AS, Brochard L, Costa EL, Schoenfeld DA, Stewart TE, Briel M, Talmor D, Mercat A, Richard JC, Carvalho CR, Brower RG. Driving pressure and survival in the acute respiratory distress syndrome. N Engl J Med. 2015 Feb 19;372(8):747-55. doi: 10.1056/NEJMsa1410639.
- Results publication: PubMed 26903337Bellani G, Laffey JG, Pham T, Fan E, Brochard L, Esteban A, Gattinoni L, van Haren F, Larsson A, McAuley DF, Ranieri M, Rubenfeld G, Thompson BT, Wrigge H, Slutsky AS, Pesenti A; LUNG SAFE Investigators; ESICM Trials Group. Epidemiology, Patterns of Care, and Mortality for Patients With Acute Respiratory Distress Syndrome in Intensive Care Units in 50 Countries. JAMA. 2016 Feb 23;315(8):788-800. doi: 10.1001/jama.2016.0291.
- Results publication: PubMed 15128988Brenner DJ. Radiation risks potentially associated with low-dose CT screening of adult smokers for lung cancer. Radiology. 2004 May;231(2):440-5. doi: 10.1148/radiol.2312030880.
- Results publication: PubMed 26397017Cinnella G, Grasso S, Raimondo P, D'Antini D, Mirabella L, Rauseo M, Dambrosio M. Physiological Effects of the Open Lung Approach in Patients with Early, Mild, Diffuse Acute Respiratory Distress Syndrome: An Electrical Impedance Tomography Study. Anesthesiology. 2015 Nov;123(5):1113-21. doi: 10.1097/ALN.0000000000000862.
- Results publication: PubMed 19255741Costa EL, Borges JB, Melo A, Suarez-Sipmann F, Toufen C Jr, Bohm SH, Amato MB. Bedside estimation of recruitable alveolar collapse and hyperdistension by electrical impedance tomography. Intensive Care Med. 2009 Jun;35(6):1132-7. doi: 10.1007/s00134-009-1447-y. Epub 2009 Mar 3.
- Results publication: PubMed 12133877Frerichs I, Hinz J, Herrmann P, Weisser G, Hahn G, Dudykevych T, Quintel M, Hellige G. Detection of local lung air content by electrical impedance tomography compared with electron beam CT. J Appl Physiol (1985). 2002 Aug;93(2):660-6. doi: 10.1152/japplphysiol.00081.2002.
- Results publication: PubMed 14566457Frerichs I, Dargaville PA, Dudykevych T, Rimensberger PC. Electrical impedance tomography: a method for monitoring regional lung aeration and tidal volume distribution? Intensive Care Med. 2003 Dec;29(12):2312-2316. doi: 10.1007/s00134-003-2029-z. Epub 2003 Oct 18.
- Results publication: PubMed 10559107Jubran A. Advances in respiratory monitoring during mechanical ventilation. Chest. 1999 Nov;116(5):1416-25. doi: 10.1378/chest.116.5.1416.
- Results publication: PubMed 20936936Matthay MA, Zemans RL. The acute respiratory distress syndrome: pathogenesis and treatment. Annu Rev Pathol. 2011;6:147-63. doi: 10.1146/annurev-pathol-011110-130158.
- Results publication: PubMed 26947624Neto AS, Hemmes SN, Barbas CS, Beiderlinden M, Fernandez-Bustamante A, Futier E, Gajic O, El-Tahan MR, Ghamdi AA, Gunay E, Jaber S, Kokulu S, Kozian A, Licker M, Lin WQ, Maslow AD, Memtsoudis SG, Reis Miranda D, Moine P, Ng T, Paparella D, Ranieri VM, Scavonetto F, Schilling T, Selmo G, Severgnini P, Sprung J, Sundar S, Talmor D, Treschan T, Unzueta C, Weingarten TN, Wolthuis EK, Wrigge H, Amato MB, Costa EL, de Abreu MG, Pelosi P, Schultz MJ; PROVE Network Investigators. Association between driving pressure and development of postoperative pulmonary complications in patients undergoing mechanical ventilation for general anaesthesia: a meta-analysis of individual patient data. Lancet Respir Med. 2016 Apr;4(4):272-80. doi: 10.1016/S2213-2600(16)00057-6. Epub 2016 Mar 4.
- Results publication: PubMed 22681860Pearce MS, Salotti JA, Little MP, McHugh K, Lee C, Kim KP, Howe NL, Ronckers CM, Rajaraman P, Sir Craft AW, Parker L, Berrington de Gonzalez A. Radiation exposure from CT scans in childhood and subsequent risk of leukaemia and brain tumours: a retrospective cohort study. Lancet. 2012 Aug 4;380(9840):499-505. doi: 10.1016/S0140-6736(12)60815-0. Epub 2012 Jun 7.
- Results publication: PubMed 27033882Pesenti A, Musch G, Lichtenstein D, Mojoli F, Amato MBP, Cinnella G, Gattinoni L, Quintel M. Imaging in acute respiratory distress syndrome. Intensive Care Med. 2016 May;42(5):686-698. doi: 10.1007/s00134-016-4328-1. Epub 2016 Mar 31.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Postpartum Period and Sepsis, run by Amazon University.
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 5 inclusion and 2 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 6 Nov 2018. 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?
Correlation of the driving pressure with the survival of puerperae under mechanical ventilation by electrical impedance tomography (time frame: Data will be collected 3 times a day in the morning, evening and evening hours until the conclusion of the study, with a mean of 3 to 5 days of monitoring by electrical impedance tomography). 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 NCT03715647, which also lists 13 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 6 Nov 2018.