Ignite Creation Date:
2024-05-06 @ 8:07 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06260826
Status:
COMPLETED
Last Update Posted:
2024-02-15
First Post:
2024-01-30
Brief Title:
CPAP on Oxygenation and Pulmonary Function in Elderly Patients After Major Open Abdominal Surgery
Sponsor:
Nguyen Dang Thu
Organization:
Vietnam Military Medical University
Study Overview
Official Title:
Comparison of Continuous Positive Airway Pressure Modes Constant Via Facial Mask vs Auto Via Nasal Mask on Oxygenation and Pulmonary Function in Elderly Patients After Major Open Abdominal Surgery
Status:
COMPLETED
Status Verified Date:
2024-02
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:
CPAP
Brief Summary:
Postoperative continuous positive airway pressure CPAP can improve lung function The risk of pulmonary complications is high after major abdominal surgery but may be reduced by prophylactic postoperative noninvasive ventilation using CPAP This study compared the effects of auto-CPAP via a nasal mask JPAP and constant-CPAP via a facial mask O2-Max Trio on oxygenation and pulmonary function in elderly patients after major open abdominal surgery
Detailed Description:
After being informed about the study and potential risks all patients giving written informed consent will undergo screening period to determine eligibility for study entry
Patients aged over 60 years scheduled for major open abdominal surgery ie gastrectomy colectomy proctocolectomy or abdominal aortic aneurysm repair
All patients received standardized anesthetic management following the established protocols of our hospital Before induction an epidural catheter was placed in the epidural space at thoracic T7-9 level for upper abdominal surgery and at lumbaric L1-3 level for lower abdominal surgery A 02 bupivacaine solution was administered with a 5 ml bolus dosage maintained at 5 mlh during surgery and the infusion rate was adjusted for pain management until postoperative day 3 General anesthesia was induced using propofol fentanyl and rocuronium with maintenance using sevoflurane Neuromuscular blockade was monitored using the train-of-four TOF stimulation Fentanyl and epidural infusion rates were adjusted to maintain the Surgical Pleth Index SPI in the range of 40-70 Extubation was only performed when the TOF ratio was 90
In the PACU after extubation all patients lay on their backs with a backrest tilted to 45 degrees Postoperative pain was assessed using a numeric rating scale NRS 0-10 and treated with epidural boluses or IV opioids if pain exceeded NRS 3 at rest or NRS 5 during movement Acute pain nausea or circulatory problems were managed and ruled out CPAP was administered when patients were conscious and had the ability to cough and expectorate phlegm
Patients were randomly assigned in a 11 ratio to either the O2-Max Trio or JPAP group through a computer-generated randomization list
Patients in the O2-Max Trio group received CPAP via the O2-Max Trio CPAP system Pulmodyne Indianapolis USA with a facial mask that was adjusted to maintain a CPAP at 75 cm H2O and FiO2 30 continuously for the following 1 h
JPAP group patients connected to the JPAP system Metran Saitama Japan via a nasal mask with the initial CPAP 2 cmH2O then reach CPAP 75 cmH2O after a ramping time of 5 minutes
Discharge from the PACU was according to a modified Aldrete discharge score The criteria for discharge from the PACU were hemodynamic stability SpO2 90 with FIO204 absence of clinical signs of respiratory distress full consciousness and sufficient diuresis 03 mlkgh
Patients aged over 60 years scheduled for major open abdominal surgery ie gastrectomy colectomy proctocolectomy or abdominal aortic aneurysm repair
All patients received standardized anesthetic management following the established protocols of our hospital Before induction an epidural catheter was placed in the epidural space at thoracic T7-9 level for upper abdominal surgery and at lumbaric L1-3 level for lower abdominal surgery A 02 bupivacaine solution was administered with a 5 ml bolus dosage maintained at 5 mlh during surgery and the infusion rate was adjusted for pain management until postoperative day 3 General anesthesia was induced using propofol fentanyl and rocuronium with maintenance using sevoflurane Neuromuscular blockade was monitored using the train-of-four TOF stimulation Fentanyl and epidural infusion rates were adjusted to maintain the Surgical Pleth Index SPI in the range of 40-70 Extubation was only performed when the TOF ratio was 90
In the PACU after extubation all patients lay on their backs with a backrest tilted to 45 degrees Postoperative pain was assessed using a numeric rating scale NRS 0-10 and treated with epidural boluses or IV opioids if pain exceeded NRS 3 at rest or NRS 5 during movement Acute pain nausea or circulatory problems were managed and ruled out CPAP was administered when patients were conscious and had the ability to cough and expectorate phlegm
Patients were randomly assigned in a 11 ratio to either the O2-Max Trio or JPAP group through a computer-generated randomization list
Patients in the O2-Max Trio group received CPAP via the O2-Max Trio CPAP system Pulmodyne Indianapolis USA with a facial mask that was adjusted to maintain a CPAP at 75 cm H2O and FiO2 30 continuously for the following 1 h
JPAP group patients connected to the JPAP system Metran Saitama Japan via a nasal mask with the initial CPAP 2 cmH2O then reach CPAP 75 cmH2O after a ramping time of 5 minutes
Discharge from the PACU was according to a modified Aldrete discharge score The criteria for discharge from the PACU were hemodynamic stability SpO2 90 with FIO204 absence of clinical signs of respiratory distress full consciousness and sufficient diuresis 03 mlkgh
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?:
True
Is an FDA AA801 Violation?:
None