Ignite Creation Date:
2024-05-11 @ 8:30 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06404151
Status:
RECRUITING
Last Update Posted:
2024-05-14
First Post:
2024-02-28
Brief Title:
Comparison of Oxygen Reserve Index and Regional Cerebral Oxygen Saturation Indetermining Hypoxia in Obese Patients
Sponsor:
Dr Lutfi Kirdar Kartal Training and Research Hospital
Organization:
Dr Lutfi Kirdar Kartal Training and Research Hospital
Study Overview
Official Title:
Comparison of Oxygen Reserve Index and Regional Cerebral Oxygen Saturation in Determining Hypoxia in Obese Patients
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary aim of this study is to compare the effectiveness of ORI and rcSO2 in predicting hypoxia early in obese patients who are sensitive to hypoxia Our secondary aim is To determine whether there is a correlation between the changing trend of ORI and rcSO2 in obese patients
Detailed Description:
Standard noninvasive monitoring will be applied to the patients taken to the operating table and heart rate mean arterial pressure peripheral oxygen saturation SpO2 oxygen reserve index ORI regional cerebral oxygen saturation etCO2 values will be recorded Cerebral oximeter probe placed in the middle of the forehead every second Cerebral oxygen saturation will be continuously monitored using a rcSO2 reading MassimoPreoxygenation will be performed until the expiratory O2 concentration is 90 during spontaneous ventilation FIO2 will be kept between 100 6 lt7min flow rate and EtCO2 30-35 mmHg 2 mg midazolam 2 ug General anesthesia with kg fentanyl 3 mgkg propofol 06 mgkg rocuronium and 100 O2 will be applied and intubated with a videolaryngoscope The breathing circuit will be disconnected from the endotracheal tube until the SpO2 drops to 94 At that time the breathing circuit will be connected and the patients will be ventilated with 100 FiO2 8 ml kg-1 ideal body weight targeted tidal volume and 5 cm H2O positive end-expiratory pressure until the ORI plateaus Throughout this process ORI and cerebral oxygen saturation will be recorded continuously ORI and rcO2 data will be compared at seven specific time points 1 during the basal period 2 at the end of preoxygenation when ORI reaches a plateau 3 at the beginning of intubation 4 when SpO2 reaches 97 5 when SpO2 reaches 94 6 ORI reaches a plateau again during ventilation with 100 FiO2 and 7 SpO2 reaches baseline
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None