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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).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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

Other trials in Turkey (Türkiye)

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.

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 groups in NCT02920138
Study groupRoleWhat they receive
Group 5PEEPAdministered 5 cmH2O positive end expiratory pressure group( Group 5PEEP n=30).
Group ZEEPno 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.

  1. 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)
  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.

  1. First posted30 Sep 2016 (estimated)
  2. Study startJan 2014
  3. Primary completionAug 2016
  4. Study completionAug 2016

Resources

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)
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 24517270
  • Yi 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 22033056
  • Sprung 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

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.

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