Unspecified Effect of Air PressureNCT02920138
The Effect of PEEP and Intraabdominal Pressure Levels on Cerebral Oxygenation Morbidly Obese.
An observational study of Unspecified Effect of Air Pressure, run by Duzce University at 1 site in Turkey (Türkiye).
Trial summary
Background: Study was designed to determine the effect of zero (ZEEP) and 5 mmHg positive end expiratory pressure (5PEEP) on cerebral oximeter levels in morbid obese patients whose undergoing laparoscopic sleeve gastrectomy. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Unspecified Effect of Air Pressure
- How many people
- 58 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jan 2014to Aug 2016
- 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: 60 morbidly obese patients which planned sleeve gastrectomy procedures under general anesthesia (ASA 2-3 status) were included in this study. Patients were devided into 2 groups which was ventileted with no positive end expiratory pressure(Group 5PEEP n=30), and 5 cmH2O positive and expiratory pressure (Group ZEEP n=30). All the patients were right hand dominate.
Who may be able to join
- morbidly obese patients
- planned sleeve gastrectomy procedures under general anesthesia
- ASA 2-3 status
- 18-60 years old
Who cannot join
- Documented coronary or periferal arterial disease,
- Unregulated diabetes mellitus,
- History of smoking,
- Symptoms of bowel or urinary bladder obstruction,
- Preoperative systolic pressure grater than 170 mmHg,
- Diastolic arterial pressure grater than 90mmHg,
Show all 10Show fewer
- Pregnancy,
- Anemia (haematocrit levels under %30),
- Symptoms of increased intracranial pressure,
- Significant stenosis of the carotid arteries.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Duzce Univercity Medical Fauculty
Düzce, 81600
About this study
Official title: The Effect of PEEP, Zero PEEP and Intraabdominal Pressure Levels on Cerebral Oxygenation (rso2) in the Morbidly Obese Undergoing Sleeve Gastrectomy
Background: Study was designed to determine the effect of zero (ZEEP) and 5 mmHg positive end expiratory pressure (5PEEP) on cerebral oximeter levels in morbid obese patients whose undergoing laparoscopic sleeve gastrectomy. Second outcome is to investigate the effect of intraabdominal pressure changes on cerebral oxygen values in LSG.
Method:18-65 yo, ASA2-3 status, 60 morbid obese patients which planned SLG under general anesthesia were included.Two patient in Group 5 PEEP were excluded because of the haemodynamic instability during procedure. Patients were divided into 2 groups which was ventilated with no PEEP (Group ZEEP)(n=30) and 5 cmH2O PEEP levels (Group5 PEEP)(n=28). All patients were use right hand dominant. Near infrared spectroscopy probes were applied to both frontal cerebral area of all patiens and measured rSO2 values. IAP were measured transvesically in all groups. Datas were recorded as basal, after induction of anesthesia, 5 minute before insufflation(5BI), 5 minute after insufflation(5BA), 15, 30, 45, 60 minute after induction, 5 minute before desufflation(5BD) and 5 minute after desufflation(5AD) time periods. Invasive arterial pressures, cerebral oxymeter values, 5 lead electrocardiography, peripheral oxygen saturation, end tidal carbondioxide, peak inspiratory pressures, intra abdominal pressure, were recorded time periods in all groups. Arterial blood sample analysed on 5BI,5AI, 5AD periods.
Read the detailed description
60 morbidly obese patients which planned sleeve gastrectomy procedures under general anestesia (ASA 2-3 status) were included in this study. Patients were devided into 2 groups which was ventilated with no positive end expiratory pressure (Group 5PEEP n=30), and 5 cmH2O positive and expiratory pressure (Group ZEEP n=30). All the patients were right hand dominate.Two patient in Group 5 PEEP were excluded because of the haemodynamic instability during procedure.
Exclusion criteria: Documented coronary or periferally arteryel disease, unregulated diabetes mellitus, history of smoking, symptoms of bowel or urinary bladder obstruction, preoperative systolic pressure grater than 170 mmHg, diastolic arterial pressure grater than 90mmHg, pregnancy, anemia (haematocrit levels under %30), and symptoms of increased intracranial pressure, significant stenosis of the carotid arteries. In all anesthetised patients were monitorised with 3 leads electrocardiography(ECG), pulse oxymetry (sPO2),invasive blood pressure(IBP), end-tidal carbondioxide (EtCO2),intraabdominal pressure levels (IAP)with intravesical urinary catheter, peak inspiratuar pressure (PIP), laparoscopic pressure (LP), regional cerebral oxygen saturation(rSO2) continuously. rSO2 values were measured with near infrared spectroscopy (NIRS) technique by cerebral oximeter (INVOS 4100, Somanetics, Covidien) measurements recorded as basal values; after induction; before 15 minute of insufflation; after 15 minute of insufflation; 30, 45, 60 after induction; before 15 minute of desufflation; after 15 minute of desufflation. Arterial blood samples were collected and performed before 15 minute of insufflation; after 15 minute of insufflation; after 15 minute of desufflation. Partial oxygen pressure(PaO2), partial carbondioxide pressure( PaCO2), peripheric oxygen saturation (SaO2), bicarbonate (HCO3), aside- base status (pH), haematocrit (Htc) haemoglobin(Hb) levels were recorded and evaluated those three time periods which explained above. Cerebral oximeter was placed skin of the patients forehead after clean special skin-prep pad. The skin sensors were applied on the right and left sides of the forehead. The medial margin of the sensor was at the midline of the forehead and lateral margin 2 cm above the eyebrows.
After induction of anesthesia a 20 gauge intraarterial cannula was placed in to left radial artery and recorded 5 minute periods.
Anesthetic procedures and measured parameters were administered same ways except of PEEP levels.
All patients were received midazolam 2mg intravenously (IV) about five minute before induction. Anesthesia was induced with fentanyl( 1-3 mcgr/kg), propofol (2-3mg/kg), rocuronium (0,6 mg/kg). After intubation anesthesia was maintained with sevoflurane 2-3 % volume (to improve MAC 1 levels for sevoflorane). Remifentanyl was given continuously during surgery at a rate of 0.05-2 mcg/kg/min) (IV). Rocuronium was administered at a rate of 30 min time intervals during the anesthesia. Sugammadex was administered at the end of the surgery for reversing the neuromuscular blockage. Tramadol 1mg/kg, 40 mg meperidine and paracetamol 1g were administered for postoperative analgesia after trochars were removed. The concentration of volatile anesthetic was monitored with GE anesthesia machine. Patients were ventilated 6 lt/dk gas flow (50% oxygen with 50% air mixture). 6-8 ml/kg tidal volume, inspiration/ expiration rate 1/2 was maintained. Respiratory rate was 8-12 breaths. EtCO2 was kept within the range 35-45 mmHg. 5mmHg PEEP was administered in Group 5 PEEP, no PEEP was administered Group ZEEP. Fluid balance and blood replacement was maintained with %0.09 NaCl and ringer or colloid(Voluven Fresenius Kabi, Graz, Austria) solution IV. Body temperature was maintained normothermic by upper body forced air and warming pads. Laparoscopic pressure was maintained at below 14mmHg throughout the operation. Intraabdominal pressure was measured in mililitres of mercury through a Foley bladder catheter with 3 stopcocks connected to infusion set and pressure transducer. IT connected to the electronic monitor of anesthesia machine. (Datex -Ohmeda S/5 Compact, GE Healthcare, Finland) . After clamping the tube 100 ml Saline solution was injected in to the bladder. The transducer was replaced and zeroed to the urinary bladder level whenever the position changes throughout the procedure. Oscillation test was performed before started the IAP measurements. This measurements was performed into two position: basal, after induction, before insuflation, after insuflation, before desuflation, after desuflation values were measured in supine position; 30min, 45 min, 60min measurements in 30 degree reverse trendelenburg position (head of the bed elevated to 30 degree). Intraabdominal hypertension was defined as an IAP of 12 mmHg or higher, according to the consensus definations of the World Society for The Abdominal Compartment Syndrome.
After end of the operation all the anesthetic agents stopped and 4 mg/kg sugammadex was performed IV.
- Conditions
- Unspecified Effect of Air Pressure
- Keywords
- Obesity, intraabdominal pressure, cerebral oxymeter, sleeve gastrectomy, laparoscopy
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group 5PEEP | Administered 5 cmH2O positive end expiratory pressure group( Group 5PEEP n=30). | |
| Group ZEEP | no positive end expiratory pressure group (Group ZEEP n=30) |
What is being measured
The primary outcome is the main question the study is designed to answer.
cerebral oximeter
To determine the effect of zero PEEP (ZEEP) and 5 mmHg positive end expiratory pressure (5PEEP) on cerebral oximeter levels in morbid obese patients whose undergoing laporoscopic sleeve gastrectomy.
Measured: 3 hours
Secondary outcomes (1)
IAP changes on cerebral oxygen values
Second outcome is to investigate the effect of intraabdominal pressure changes on cerebral oxygen values in LSG.
Measured: 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2016 (estimated)
- Study startJan 2014
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Unspecified Effect of Air PressureStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duzce University
- Sponsor type
- University, hospital or other
- Collaborators
- Bezmialem Vakif University
- Responsible party
- Sponsor
- Investigators
- İlknur S Şeker, Study director, Duzce University Faculty of Medicine Anesthesiology and Intensive Care Depth, Duzce, TurkeyYavuz Demiraran, Principal investigator, Canakkale 18 Mart University, School of Medicine Department of Anesthesiology and Reanimation, Canakkale, TurkeyZiya Salihoğlu, Principal investigator, Istanbul University Cerrahpaşa Medical Faculty, Anesthesiology and Intensive Care Depth, Istanbul, TurkeyTarık Umutoğlu, Principal investigator, Bezmialem Vakif University, Faculty of Medicine, Anesthesiology and Intensive Care Depth, Istanbul, Turkeyİsmet Özaydın, Principal investigator, Duzce University Faculty of Medicine General Surgery Depth, Duzce, TurkeySami Doğan, Principal investigator, Duzce University Faculty of Medicine General Surgery Depth, Duzce, Turkey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02920138
- Sponsor's protocol ID
- DuzceU
- Status last verified
- Apr 2019
- First submitted
- 27 Sep 2016
- Last updated
- 22 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Kim MS, Bai SJ, Lee JR, Choi YD, Kim YJ, Choi SH. Increase in intracranial pressure during carbon dioxide pneumoperitoneum with steep trendelenburg positioning proven by ultrasonographic measurement of optic nerve sheath diameter. J Endourol. 2014 Jul;28(7):801-6. doi: 10.1089/end.2014.0019. Epub 2014 Mar 5.
PubMed 24517270Yi M, Leng Y, Bai Y, Yao G, Zhu X. The evaluation of the effect of body positioning on intra-abdominal pressure measurement and the effect of intra-abdominal pressure at different body positioning on organ function and prognosis in critically ill patients. J Crit Care. 2012 Apr;27(2):222.e1-6. doi: 10.1016/j.jcrc.2011.08.010. Epub 2011 Oct 26.
PubMed 22033056Sprung J, Whalley DG, Falcone T, Warner DO, Hubmayr RD, Hammel J. The impact of morbid obesity, pneumoperitoneum, and posture on respiratory system mechanics and oxygenation during laparoscopy. Anesth Analg. 2002 May;94(5):1345-50. doi: 10.1097/00000539-200205000-00056.
PubMed 11973218
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of PEEP, Zero PEEP and Intraabdominal Pressure Levels on Cerebral Oxygenation (rso2) in the Morbidly Obese Undergoing Sleeve Gastrectomy
- ClinicalTrials.gov ID
- NCT02920138
- Acronym / sponsor ID
- DuzceU
- Conditions
- Unspecified Effect of Air Pressure
- Keywords
- Obesity, intraabdominal pressure, cerebral oxymeter, sleeve gastrectomy, laparoscopy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Duzce UniversityUniversity, hospital or other
- Collaborators
- Bezmialem Vakif University
- Study start
- Jan 2014
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 30 Sep 2016 (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.
Background: Study was designed to determine the effect of zero (ZEEP) and 5 mmHg positive end expiratory pressure (5PEEP) on cerebral oximeter levels in morbid obese patients whose undergoing laparoscopic sleeve gastrectomy. Second outcome is to investigate the effect of intraabdominal pressure changes on cerebral oxygen values in LSG.
Method:18-65 yo, ASA2-3 status, 60 morbid obese patients which planned SLG under general anesthesia were included.Two patient in Group 5 PEEP were excluded because of the haemodynamic instability during procedure. Patients were divided into 2 groups which was ventilated with no PEEP (Group ZEEP)(n=30) and 5 cmH2O PEEP levels (Group5 PEEP)(n=28). All patients were use right hand dominant. Near infrared spectroscopy probes were applied to both frontal cerebral area of all patiens and measured rSO2 values. IAP were measured transvesically in all groups. Datas were recorded as basal, after induction of anesthesia, 5 minute before insufflation(5BI), 5 minute after insufflation(5BA), 15, 30, 45, 60 minute after induction, 5 minute before desufflation(5BD) and 5 minute after desufflation(5AD) time periods. Invasive arterial pressures, cerebral oxymeter values, 5 lead electrocardiography, peripheral oxygen saturation, end tidal carbondioxide, peak inspiratory pressures, intra abdominal pressure, were recorded time periods in all groups. Arterial blood sample analysed on 5BI,5AI, 5AD periods.
Detailed description
60 morbidly obese patients which planned sleeve gastrectomy procedures under general anestesia (ASA 2-3 status) were included in this study. Patients were devided into 2 groups which was ventilated with no positive end expiratory pressure (Group 5PEEP n=30), and 5 cmH2O positive and expiratory pressure (Group ZEEP n=30). All the patients were right hand dominate.Two patient in Group 5 PEEP were excluded because of the haemodynamic instability during procedure.
Exclusion criteria: Documented coronary or periferally arteryel disease, unregulated diabetes mellitus, history of smoking, symptoms of bowel or urinary bladder obstruction, preoperative systolic pressure grater than 170 mmHg, diastolic arterial pressure grater than 90mmHg, pregnancy, anemia (haematocrit levels under %30), and symptoms of increased intracranial pressure, significant stenosis of the carotid arteries. In all anesthetised patients were monitorised with 3 leads electrocardiography(ECG), pulse oxymetry (sPO2),invasive blood pressure(IBP), end-tidal carbondioxide (EtCO2),intraabdominal pressure levels (IAP)with intravesical urinary catheter, peak inspiratuar pressure (PIP), laparoscopic pressure (LP), regional cerebral oxygen saturation(rSO2) continuously. rSO2 values were measured with near infrared spectroscopy (NIRS) technique by cerebral oximeter (INVOS 4100, Somanetics, Covidien) measurements recorded as basal values; after induction; before 15 minute of insufflation; after 15 minute of insufflation; 30, 45, 60 after induction; before 15 minute of desufflation; after 15 minute of desufflation. Arterial blood samples were collected and performed before 15 minute of insufflation; after 15 minute of insufflation; after 15 minute of desufflation. Partial oxygen pressure(PaO2), partial carbondioxide pressure( PaCO2), peripheric oxygen saturation (SaO2), bicarbonate (HCO3), aside- base status (pH), haematocrit (Htc) haemoglobin(Hb) levels were recorded and evaluated those three time periods which explained above. Cerebral oximeter was placed skin of the patients forehead after clean special skin-prep pad. The skin sensors were applied on the right and left sides of the forehead. The medial margin of the sensor was at the midline of the forehead and lateral margin 2 cm above the eyebrows.
After induction of anesthesia a 20 gauge intraarterial cannula was placed in to left radial artery and recorded 5 minute periods.
Anesthetic procedures and measured parameters were administered same ways except of PEEP levels.
All patients were received midazolam 2mg intravenously (IV) about five minute before induction. Anesthesia was induced with fentanyl( 1-3 mcgr/kg), propofol (2-3mg/kg), rocuronium (0,6 mg/kg). After intubation anesthesia was maintained with sevoflurane 2-3 % volume (to improve MAC 1 levels for sevoflorane). Remifentanyl was given continuously during surgery at a rate of 0.05-2 mcg/kg/min) (IV). Rocuronium was administered at a rate of 30 min time intervals during the anesthesia. Sugammadex was administered at the end of the surgery for reversing the neuromuscular blockage. Tramadol 1mg/kg, 40 mg meperidine and paracetamol 1g were administered for postoperative analgesia after trochars were removed. The concentration of volatile anesthetic was monitored with GE anesthesia machine. Patients were ventilated 6 lt/dk gas flow (50% oxygen with 50% air mixture). 6-8 ml/kg tidal volume, inspiration/ expiration rate 1/2 was maintained. Respiratory rate was 8-12 breaths. EtCO2 was kept within the range 35-45 mmHg. 5mmHg PEEP was administered in Group 5 PEEP, no PEEP was administered Group ZEEP. Fluid balance and blood replacement was maintained with %0.09 NaCl and ringer or colloid(Voluven Fresenius Kabi, Graz, Austria) solution IV. Body temperature was maintained normothermic by upper body forced air and warming pads. Laparoscopic pressure was maintained at below 14mmHg throughout the operation. Intraabdominal pressure was measured in mililitres of mercury through a Foley bladder catheter with 3 stopcocks connected to infusion set and pressure transducer. IT connected to the electronic monitor of anesthesia machine. (Datex -Ohmeda S/5 Compact, GE Healthcare, Finland) . After clamping the tube 100 ml Saline solution was injected in to the bladder. The transducer was replaced and zeroed to the urinary bladder level whenever the position changes throughout the procedure. Oscillation test was performed before started the IAP measurements. This measurements was performed into two position: basal, after induction, before insuflation, after insuflation, before desuflation, after desuflation values were measured in supine position; 30min, 45 min, 60min measurements in 30 degree reverse trendelenburg position (head of the bed elevated to 30 degree). Intraabdominal hypertension was defined as an IAP of 12 mmHg or higher, according to the consensus definations of the World Society for The Abdominal Compartment Syndrome.
After end of the operation all the anesthetic agents stopped and 4 mg/kg sugammadex was performed IV.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 5PEEP | – | –Administered 5 cmH2O positive end expiratory pressure group( Group 5PEEP n=30). |
| Group ZEEP | – | –no positive end expiratory pressure group (Group ZEEP n=30) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- 60 morbidly obese patients which planned sleeve gastrectomy procedures under general anesthesia (ASA 2-3 status) were included in this study. Patients were devided into 2 groups which was ventileted with no positive end expiratory pressure(Group 5PEEP n=30), and 5 cmH2O positive and expiratory pressure (Group ZEEP n=30). All the patients were right hand dominate.
Key inclusion criteria (4 listed)
- morbidly obese patients
- planned sleeve gastrectomy procedures under general anesthesia
- ASA 2-3 status
- 18-60 years old
Key exclusion criteria (10 listed)
- Documented coronary or periferal arterial disease,
- Unregulated diabetes mellitus,
- History of smoking,
- Symptoms of bowel or urinary bladder obstruction,
- Preoperative systolic pressure grater than 170 mmHg,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
cerebral oximeter
Time frame: 3 hours
To determine the effect of zero PEEP (ZEEP) and 5 mmHg positive end expiratory pressure (5PEEP) on cerebral oximeter levels in morbid obese patients whose undergoing laporoscopic sleeve gastrectomy.
1 secondary outcome
IAP changes on cerebral oxygen values
Time frame: 3 hours
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 22 Apr 2019.
- Background: PubMed 24517270Kim MS, Bai SJ, Lee JR, Choi YD, Kim YJ, Choi SH. Increase in intracranial pressure during carbon dioxide pneumoperitoneum with steep trendelenburg positioning proven by ultrasonographic measurement of optic nerve sheath diameter. J Endourol. 2014 Jul;28(7):801-6. doi: 10.1089/end.2014.0019. Epub 2014 Mar 5.
- Background: PubMed 22033056Yi M, Leng Y, Bai Y, Yao G, Zhu X. The evaluation of the effect of body positioning on intra-abdominal pressure measurement and the effect of intra-abdominal pressure at different body positioning on organ function and prognosis in critically ill patients. J Crit Care. 2012 Apr;27(2):222.e1-6. doi: 10.1016/j.jcrc.2011.08.010. Epub 2011 Oct 26.
- Background: PubMed 11973218Sprung J, Whalley DG, Falcone T, Warner DO, Hubmayr RD, Hammel J. The impact of morbid obesity, pneumoperitoneum, and posture on respiratory system mechanics and oxygenation during laparoscopy. Anesth Analg. 2002 May;94(5):1345-50. doi: 10.1097/00000539-200205000-00056.
- Individual participant dataSharing planned: No
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.
İlknur S Şeker study director
Duzce University Faculty of Medicine Anesthesiology and Intensive Care Depth, Duzce, Turkey
Yavuz Demiraran principal investigator
Canakkale 18 Mart University, School of Medicine Department of Anesthesiology and Reanimation, Canakkale, Turkey
Ziya Salihoğlu principal investigator
Istanbul University Cerrahpaşa Medical Faculty, Anesthesiology and Intensive Care Depth, Istanbul, Turkey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Unspecified Effect of Air Pressure, run by Duzce University at 1 site in Turkey (Türkiye).
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 4 inclusion and 10 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 22 Apr 2019. 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 Turkey (Türkiye). 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?
cerebral oximeter (time frame: 3 hours). 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 NCT02920138, which also lists 3 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 22 Apr 2019.