Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06513702
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-16
Brief Title:
To Determine the Effectiveness of Transesophageal Lung Ultrasound Guided Recruitment Maneuver in Cardiac Surgery
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Effectiveness of Transesophageal Lung Ultrasound TELUS Guided Recruitment Maneuver to Reduce Lung Atelectasis After Cardiac Surgery a Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TELUS-REM
Brief Summary:
This study is to evaluate the effectiveness of Transesophageal Lung ULtrasound TELUS guided recruitment maneuver to reduce lung atelelectasis in cardiac surgery This is a RCT trial involving a cardiac patient that requiring used of cardiopulmonary bypass machine intraoperatively These patient will be randomized into either intervention group or control group
Detailed Description:
Post operative pulmonary complications is a common cause of morbidity and mortality in cardiac surgery Lung atelectasis collapse contributes to dysfunctional of right ventricular performance post cardiac surgery due to increase impedance in right ventricular outflow tract Recruitment Lung re-expansion maneuver is proven to be effective to reverse this effect however it is not routinely done intraoperatively In this study we are conducting a randomized controlled trial to evaluate effectiveness of transesophageal lung ultrasound TELUS guided recruitment maneuver to reduce incidence of lung atelectasis in cardiac surgery By this intervention we hope that it will lead to reduce the incidence of postoperative pulmonary complications after undergoing cardiopulmonary bypass surgery
This is a single centerprospective a randomized controlled trial RCT study in cardiac surgery patient
Patient will be randomized into 2 groups after consented into this study After the operating list has been confirmed we will visit the patients to be recruited explain the purposes of this study and then offer them to participate in this study If the patients agree to participate in this study they will need to sign a consent form in Malay or English language Each participant will be assigned a code number to protect their confidentiality and the code number will be written clearly on an opaque envelope The opaque envelope will contain participants consent form patient information sheet and data collection sheet Patient will be randomized by computer generated system into control group group C and recruitment maneuver group group RM
On the day of operation the operation will be proceeded under general anesthesia as per standard practice Induction and maintenance of anesthesia will be conducted as per standard practice
Standard arterial and central venous catheterization will be inserted in all patients The operation will be proceeded as per usual practice The patient will be put on cardiopulmonary bypass CBP machine as per usual practice and the operation will be done as per scheduled Mechanical ventilator will be suspended during CBP Once CBP was disconnected lung will be reinflated by giving five deep manual bag insufflations until full lung expansion observed by anaesthetist however in interventional group lung inflation is guided by transesophageal lung ultrasound During sternal wiring approximately about 30 minutes before the end of surgery in interventional group they will receive a lung recruitment maneuver by continuous CPAP at 30cmH2o for 20seconds followed by PEEP 0f 8cmH20 In both groups lung ultrasound and heart ultrasound TOE will be done to evaluate lung and heart function Further assessment will be done in RM group with lung and heart ultrasound to look for changes after lung recruitment maneuver If there is still evidence of lung collapse in the second assessment repeated lung recruitment maneuver will be done with continuous CPAP at 40cmh20 for 20 seconds The lung recruitment maneuver will be immediately stopped if there were signs of hypovolaemia impairment in right ventricular contraction or a change at least 15 of baseline MAP and HR or desaturation
Once operation is completed patients will be reassessed again by heart ultrasound The patient then will be transferred to the Cardiac Intensive Care Unit CICU The patient will be wean off from mechanical ventilator once condition permitted
After surgery the investigator will assess patients daily to obtain the clinical data The patient then will be continued to be follow up until the day of discharge from hospital
This is a single centerprospective a randomized controlled trial RCT study in cardiac surgery patient
Patient will be randomized into 2 groups after consented into this study After the operating list has been confirmed we will visit the patients to be recruited explain the purposes of this study and then offer them to participate in this study If the patients agree to participate in this study they will need to sign a consent form in Malay or English language Each participant will be assigned a code number to protect their confidentiality and the code number will be written clearly on an opaque envelope The opaque envelope will contain participants consent form patient information sheet and data collection sheet Patient will be randomized by computer generated system into control group group C and recruitment maneuver group group RM
On the day of operation the operation will be proceeded under general anesthesia as per standard practice Induction and maintenance of anesthesia will be conducted as per standard practice
Standard arterial and central venous catheterization will be inserted in all patients The operation will be proceeded as per usual practice The patient will be put on cardiopulmonary bypass CBP machine as per usual practice and the operation will be done as per scheduled Mechanical ventilator will be suspended during CBP Once CBP was disconnected lung will be reinflated by giving five deep manual bag insufflations until full lung expansion observed by anaesthetist however in interventional group lung inflation is guided by transesophageal lung ultrasound During sternal wiring approximately about 30 minutes before the end of surgery in interventional group they will receive a lung recruitment maneuver by continuous CPAP at 30cmH2o for 20seconds followed by PEEP 0f 8cmH20 In both groups lung ultrasound and heart ultrasound TOE will be done to evaluate lung and heart function Further assessment will be done in RM group with lung and heart ultrasound to look for changes after lung recruitment maneuver If there is still evidence of lung collapse in the second assessment repeated lung recruitment maneuver will be done with continuous CPAP at 40cmh20 for 20 seconds The lung recruitment maneuver will be immediately stopped if there were signs of hypovolaemia impairment in right ventricular contraction or a change at least 15 of baseline MAP and HR or desaturation
Once operation is completed patients will be reassessed again by heart ultrasound The patient then will be transferred to the Cardiac Intensive Care Unit CICU The patient will be wean off from mechanical ventilator once condition permitted
After surgery the investigator will assess patients daily to obtain the clinical data The patient then will be continued to be follow up until the day of discharge from hospital
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