Ignite Creation Date:
2024-05-06 @ 11:33 AM
Last Modification Date:
2024-10-26 @ 12:47 PM
Study NCT ID:
NCT03547648
Status:
COMPLETED
Last Update Posted:
2018-11-20
First Post:
2018-05-23
Brief Title:
Effect of Three Different Peak Airway Pressures on Determining Intraoperative Bleeding in Thryroidectomies
Sponsor:
Istanbul University
Organization:
Istanbul University
Study Overview
Official Title:
Comparison of the Effect of Three Different Peak Airway Pressures on Determining Intraoperative Bleeding Points in Thyroidectomies
Status:
COMPLETED
Status Verified Date:
2018-11
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:
Patients undergoing thyroidectomy will be divided into three groups 30 cm H2O Group I 40 cm H2O Group II 50 cmH2O Group III At the end of the operation patients will be applied peak airway pressure manually according to involved groupsThe time until the first hemorrhage is seen in each group or if not seen pressure will be applied for 30 seconds and then will be endedWe will record the blood pressure spO2 HR the first ETCO2 after the procedure postoperative haemorrhage that required surgery and postoperative hematomas during peak airway pressure increase during the operation in all patients The 1st hour blood pressure nausea-vomiting score and pain score NRS will be recorded in the postoperative recovery unit
The primary end point of the study is intraoperative bleeding detected and the secondary end point is postoperative bleeding
The primary end point of the study is intraoperative bleeding detected and the secondary end point is postoperative bleeding
Detailed Description:
Patients will be divided into three groups httpswwwrandomizerorg by computer assisted randomization method 30 cm H2O in Group I 40 cm H2O in Group II 50 cmH2O in Group III peak pressure will be applied The time until the first hemorrhage is seen in each group or if not seen pressure will be applied for 30 seconds and then will be ended
Patients will be taken to the operation table and standard monitorization will be performed consisting of ECG non-invasive blood pressure and peripheral O2 saturation from the back region Anesthesia was induced with 2 mg kg propofol propofol 1 Fresenius Fresenius Kabi Germany 2 mg kg fentanyl Talinat 05mg 10ml AND Turkey 06 mg kg rocuronium Muscuro 50mg 5ml Kocak Farma Turkey will be provided after the patients were intubated orally General anesthesia treatment will be provided with 2 Sevoflurane in 40 oxygen-air mixture All patients will be ventilated in pressure controlled mode respiratory frequency 12 min FiO2 40 oxygen-air mixture IE12 PEEP 7 cmH2O supplying end tidal CO2 value of 32-36 mmHg
Calculating the ideal weight of the patient isolated-S Polifarma Turkey2mlkgh will be infused If the systolic arterial pressure SAB or heart rate HR increases by 20 compared to baseline IV 50 μg fentanyl will be administered At the end of the operation the patients airway peak pressure will be increased before hemostasis is provided by the same surgeon ST Positive pressure on the Maquet Flow I device Maquet Flow I-AGC Rastatt USA will be applied manually30 cm H2O in Group I 40 cm H2O in Group II patients and 50 cm H2O in group III patients The airway peak pressure increase will be maintained and recorded until the surgeon sees the first bleeding point or if not seen for 30 seconds For all three groups this process will be repeated one more time
After peak airway pressure is increased the number of bleeding centers detected how long time did it take to detect and the size of the bleeding vessel 2 mm or 2 mmwill be recorded We will record the blood pressure spO2 HR the first ETCO2 after the procedure postoperative haemorrhage that required surgery and postoperative hematomas during peak airway pressure increase during the operation in all patients The 1st hour blood pressure nausea-vomiting score and pain score NRS will be recorded in the postoperative recovery unit
The primary end point of the study is intraoperative bleeding detected and w the secondary end point is postoperative bleeding
Patients will be taken to the operation table and standard monitorization will be performed consisting of ECG non-invasive blood pressure and peripheral O2 saturation from the back region Anesthesia was induced with 2 mg kg propofol propofol 1 Fresenius Fresenius Kabi Germany 2 mg kg fentanyl Talinat 05mg 10ml AND Turkey 06 mg kg rocuronium Muscuro 50mg 5ml Kocak Farma Turkey will be provided after the patients were intubated orally General anesthesia treatment will be provided with 2 Sevoflurane in 40 oxygen-air mixture All patients will be ventilated in pressure controlled mode respiratory frequency 12 min FiO2 40 oxygen-air mixture IE12 PEEP 7 cmH2O supplying end tidal CO2 value of 32-36 mmHg
Calculating the ideal weight of the patient isolated-S Polifarma Turkey2mlkgh will be infused If the systolic arterial pressure SAB or heart rate HR increases by 20 compared to baseline IV 50 μg fentanyl will be administered At the end of the operation the patients airway peak pressure will be increased before hemostasis is provided by the same surgeon ST Positive pressure on the Maquet Flow I device Maquet Flow I-AGC Rastatt USA will be applied manually30 cm H2O in Group I 40 cm H2O in Group II patients and 50 cm H2O in group III patients The airway peak pressure increase will be maintained and recorded until the surgeon sees the first bleeding point or if not seen for 30 seconds For all three groups this process will be repeated one more time
After peak airway pressure is increased the number of bleeding centers detected how long time did it take to detect and the size of the bleeding vessel 2 mm or 2 mmwill be recorded We will record the blood pressure spO2 HR the first ETCO2 after the procedure postoperative haemorrhage that required surgery and postoperative hematomas during peak airway pressure increase during the operation in all patients The 1st hour blood pressure nausea-vomiting score and pain score NRS will be recorded in the postoperative recovery unit
The primary end point of the study is intraoperative bleeding detected and w the secondary end point is postoperative bleeding
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None