Effect of PCO2 Gap Algorithm Application on Outcome of High Risk Surgical Patients Undergoing Major Abdominal Surgeries
NCT ID: NCT04792242
Last Updated: 2021-03-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
40 participants
INTERVENTIONAL
2019-11-10
2021-03-07
Brief Summary
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Comparison between goal directed therapy and PCO2 gap algorithm (carbon dioxide partial pressure venous arterial gap algorithm) application on 30 days mortality and organ dysfunction post operative
2. Secondary (subsidiary):
Comparison between goal directed therapy and PCO2 gap algorithm application on number of ventilator dependant days, number of days on vasopressors or inotropes length of ICU stay, length of hospital stay,
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Detailed Description
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All participants will be evaluated pre operatively and pre medicated according to protocols in our hospital, base line sequential organ failure (SOFA) score will be taken. General anesthesia for all patients will be carried on according to our local standards. As part of our routine hemodynamic monitoring during major surgery, all patients will be monitored with central venous (standard three-lumen catheter) and arterial catheters placed before the beginning of surgery. The central venous line will be positioned with the tip within the superior vena cava, and correct positioning will be verified by chest radiograph.
the participants will be divided randomly onto to groups using numerical system group A PCO2 gap algorithm(carbon dioxide partial pressure venous arterial gap) will be applied intraoperative and 12 h postoperative end point PCO2 gap 2-6mm Hg(appendix 1).
Group B goal directed therapy protocol which will include targets mean arterial blood pressure ( MAP) \> 65 mmHg, central venous pressure(CVP) between 8-12 cmH2O , Haematocrite value more than 30, mixed venous oxygen saturation (Svo2) \>75% and urine output more than \>0.5 ml/kg/hr and will be applied intraoperative and 12 postoperative end point base deficit +/- 2(appendix 2 ).
All participants will be admitted to the ICU (intensive care unit) immediately after surgery .Standard postoperative monitoring will include: electrocardiograph (heart rate), invasive mean arterial pressure, pulse oxygen saturation and urine output then will be all managed according to their allocated group for 12 hours.
Outcomes in both groups will be recorded which will be number of ventilator dependant days, number of days on vasopressors or inotropes length of ICU stay, length of hospital stay, 30 days organ dysfunction, assessed by using the Sequential Organ Failure Assessment (SOFA) and 30 days mortality .
Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
SINGLE
Study Groups
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goal directed therapy
svo2,haematocrite value,urine output,mean arterial pressure and central venous pressure
cv line insertion
Svo2 and central venous pressure measurements
Urinary catheter insertion
urine output measurement
PCO2 gap algorithm
PCO2 gap,haematocrite value,Spo2,cardiac index
cv line insertion
Svo2 and central venous pressure measurements
Urinary catheter insertion
urine output measurement
Arterial line
Arterial blood gases measurment
Interventions
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cv line insertion
Svo2 and central venous pressure measurements
Urinary catheter insertion
urine output measurement
Arterial line
Arterial blood gases measurment
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
ALL
No
Sponsors
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South Valley University
OTHER
Responsible Party
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Hassan Abdelsapour Abdelrazek
PhD Candidat
Locations
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South Valley University
Luxor, Qena Governorate, Egypt
Countries
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Other Identifiers
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SVU.MED.AIP029.4.1
Identifier Type: -
Identifier Source: org_study_id
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