Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202309486066044 Date of Approval: 21/09/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Plethysmography variation index versus Pulse pressure variation as an indicator of fluid responsiveness in colorectal surgeries during immediate postoperative period.
Official scientific title Plethysmography variation index versus Pulse pressure variation as an indicator of fluid responsiveness in colorectal surgeries during immediate postoperative period.
Brief summary describing the background and objectives of the trial Dynamic predictors of fluid responsiveness have shown good performance in mechanically ventilated patients at tidal volumes (Vt) > 8 mL kg−1. Numerous studies support the usefulness of dynamic indices based on heart-lung interaction for predicting fluid responsiveness in mechanically ventilated patients. Respiratory changes in the amplitude of the plethysmographic pulse wave have also been shown to reliably predict fluid responsiveness. A new algorithm, called the plethysmographic variability index (PVI) (Masimo, Irvine, CA), has recently been proposed to predict fluid responsiveness. This index presents the advantage of being calculated automatically and displayed continuously on the screen of the pulse oximeter. The aim of this study is to compare the efficacy and specificity between plethysmography variation index (PVI)and pulse pressure variation (PPV) to achieve better fluid responsiveness results in ICU after colorectal surgeries aiming to decrease postoperative complications from fluid over load and decrease hospital stay.
Type of trial Observational
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,Circulatory System,fluid responsiveness in patients in icu after colorectal surgeries using dynamic indices as PVI
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Diagnosis / Prognosis
Anticipated trial start date 14/03/2021
Actual trial start date 14/03/2021
Anticipated date of last follow up 12/03/2022
Actual Last follow-up date 12/03/2022
Anticipated target sample size (number of participants) 103
Actual target sample size (number of participants) 103
Recruitment status Completed
Publication URL https://www.apicareonline.com/index.php/APIC
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Crossover: all participants receive all interventions in different sequence during study Non-randomised Sealed opaque envelopes Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group plethysmography variability index every 2 hours for 24 hours immediately post operatively during the first 24 hours postoperatively after colorectal surgery On admission to ICU heart rate, PPV, CI, and PVI were recorded immediately after volume expansion by infusing saline 500 ml over 30 mins and after which PPV, CI, PVI were recorded every 2 hours for the first 24 hours.The PVI was recorded using a Masimo Radical-7® monitor (Masimo Corp., Irvine, CA). A pulse oximeter probe was placed on the finger and wrapped with a black protector to minimize light interference. The probe was connected to the Masimo Radical 7 monitor. The PVI was automatically calculated from plethysmographic waveform analysis. 103
Experimental Group Pulse pressure variation Recording was done every 2 hours for the first 24 hours. for the first 24 hours postoperatively. On admission to ICU heart rate, PPV, CI, and PVI were recorded immediately after volume expansion by infusing saline 500 ml over 30 mins and after which PPV, CI, PVI were recorded every 2 hours for the first 24 hours. The PPV was calculated as follows using an invasive radial arterial line : the maximum (during inspiration) and the minimum (during exhalation) waveforms were identified on the undulating invasive blood pressure pattern. The systolic pressure value for the largest, or maximum inspiratory waveform, then the diastolic pressure was found. The difference in these two values is your pulse pressure. 103
Control Group cardiac index if cardiac index is increased by equal or more than 15 % is considered fluid responder if cardiac index is less than 15% or didn't change them the patient is considered non responder to fluid . Measurement is done every 2 hours for 24 hours postoperatively. for 24 hours postoperatively after colorectal surgeries Cardiac Index (CI) was calculated using CO and BW and height. Patients with a >15% increase were defined as “volume responders." Patients with no change or a change of <15% were defined as “non responders." When cardiac output exceeded 15%, fluid challenge was stopped. CO was estimated by transthoracic echocardiography. Cardiac output will be calculated from the left ventricular outflow tract (LVOT) as described by Mercado et al., 2017. The diameter of the LVOT was taken to be the distance between the bases of the aortic valve cusp during systole, as seen from the long parasternal view. The aortic valve area was calculated from systolic LVOT areas. The LVOT area was calculated assuming a circular geometry. In order to reduce variability we used the average of three measures of LVOT diameter. The LVOT area was calculated as the product radius squared: LVOT area=[(LVOT diameter average / 2)2]×3.14. 103 Dose Comparison
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1- Age ≥18 years and <65 years. 2- Patients admitted to the ICU after performing colorectal surgeries. 3- APACHE II SCORE will be done to all patients admitted to ICU after colorectal surgery. 4- Patients on controlled mechanical ventilation with tidal volume at least 8ml/kg and sedated. 5- Patients requiring intravenous fluid challenge for resuscitation based on the clinical characteristics as systolic arterial blood pressure (SBP) <90 mmHg or mean arterial pressure (MAP) <65 mmHg with signs of hypoperfusion (oliguria less than 0.5 ml/kg/h, arterial lactate >2.5 mMol/L). 6- Patients with an arterial catheter and central venous catheter via the internal jugular vein or the subclavian vein. 7- Patients with normal sinus rhythm. 1- Un satisfactory cardiacechogenicity. 2- Preexisting severe valvular heart disease. 3- Known tricuspid insufficiency, intracardiac shunt or cardiac arrhythmia. 4- Low left ventricular function (ejection fraction < 40%). 5- Any contraindication to fluid resuscitation, such as congestive heart failure, evidence of fluid overload or renal dysfunction. 6- Lung pathologies (like asthma, COPD). 7- Patients with contraindications for sedation by narcotics and midazolam like hepatic or renal dysfunction. 8- Patients suffering from type I /II diabetes. 9- Patients whose temporary removal of the compression stocking owing to venous insufficiency (i.e., deep venous thrombosis) could endanger patient safety. Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 64 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 14/03/2021 Research ethical committee ay faculty of medicine Ainshams university
Ethics Committee Address
Street address City Postal code Country
Ramsis Street cairo 11591 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The primary outcome is to compare effectiveness of PVI to PPV in predicting fluid response using cardiac index in patients admitted to ICU after colorectal surgery.The secondary outcome include the development of some possible complications such as bradycardia, hypotension , arterial spasm upon application of invasive blood pressure, hematoma They will be recorded every 30 mins for the first 2 hours after patient admission to the ICU after colorectal surgery. Then every 2 hours for the rest 24 hours.
Secondary Outcome The secondary outcome include the development of some possible complications such as bradycardia, hypotension , arterial spasm upon application of invasive blood pressure, hematoma . every 30 mins for the first 2 hours after patient admission to the ICU after colorectal surgery. Then every 2 hours for the rest 24 hours.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
faculty of medicine Ain shams university 56 rams street ,al abasseya cairo 11517 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
maye mohsen abdel Sattar alamir 32 Melsa buildings, Ard el golf , Al nozha street cairo 11765 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of medicine Ain shams university Ramsis ,Abasseya square cairo 11591 Egypt University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Maye Alamir maye.mohsen@med.asu.edu.eg +201222337282 32 Melsa buildings , al nozha street , ard el golf
City Postal code Country Position/Affiliation
cairo 11765 Egypt assistant lecturer of anaesthesia intensive care and pain management
Role Name Email Phone Street address
Public Enquiries ossama Mansour vice.research@med.asu.edu.eg +20224346344 ramsis, abasseya square
City Postal code Country Position/Affiliation
cairo 11591 Egypt vice dean of research committee at faculty of medicine
Role Name Email Phone Street address
Scientific Enquiries Mohamed al fouly mofouly@hotmail.com 01156555589 Ramsis Street
City Postal code Country Position/Affiliation
cairo 11591 Egypt lecturer of anesthesiology intensive care and pain management
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Not available Study Protocol Not applicable not applicable
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information