Fluid Management During Elective Spine SurgeriesNCT05239286
Conventional Fluid Management vs Plethysmographic Variability Index -Based Goal Directed Fluid Management
A study testing General anaesthesia, Conventional fluid managment and PVI dependant goal directed fluid therapy in people with Fluid Management During Elective Spine Surgeries, run by Cairo University at 1 site in Egypt.
Trial summary
Plethysmographic variability index is a dynamic method for evaluation of volume status which depends on estimation of respiratory variations in pulse oximeter waveform amplitude. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Fluid Management During Elective Spine Surgeries
- What is being tested?
- General anaesthesia, Conventional fluid managment and PVI dependant goal directed fluid therapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteEgypt
- Study dates
- 24 Jan 2022to 30 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • Adult patients (18-65 years)
- ASA I-II
- Patients scheduled for elective lumbar spine surgeries (e.g.: Lumbar fixation and simple discectomy) under general anaesthesia in prone position.
Who cannot join
- • Operations which will last for less than 15 minutes. (e.g.: plate and screw adjustment or incomplete terminated surgery)
- Patients with cardiac morbidities e.g. history of unstable angina, impaired contractility with ejection fraction < 40%, wall motional abnormalities or tight valvular lesions detected by echocardiography, previous cardiac operations or cardiac catherization with stent.
- Patients with heart block and arrhythmia (atrial fibrillation and frequent ventricular or supraventricular premature beat).
- Patient with decompensated respiratory disease (poor functional capacity, generalized wheezes, peripheral O2 saturation < 90% on room air).
- Patients with peripheral vascular disease or long-standing DM affecting PVI readings.
- Complicated surgeries (huge spine tumors, intraoperative vascular or neurological complications and prolonged durations more than 5 hours) or surgeries with massive blood loss (4 units of packed RBCs in 1 hour or replacement of 50% of total blood volume within 3 hours )
- Pregnancy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison Between Conventional Fluid Management and Plethysmographic Variability Index Based Goal Directed Fluid Management in Patients Undergoing Spine Surgeries in Prone Position; A Randomized Control Trial.
Plethysmographic variability index is a dynamic method for evaluation of volume status which depends on estimation of respiratory variations in pulse oximeter waveform amplitude. The PVI has been studied in various patient populations and clinical settings, and has been shown to reliably predict fluid responsiveness and guide fluid resuscitation.
conventional fluid management. Fluid replacement is managed according to clinical assessment, heart rate, arterial blood pressure and central venous pressure monitoring. However, clinical studies indicate that changes in ABP cannot be used for the monitoring of stroke volume and cardiac output. Another method is the goal-directed fluid management and it is based on individualized fluid management using static and dynamic parameters.
Read the detailed description
This study aims to compare the conventional fluid managment and Plethysmographic Variability index based during elective spine surgeries in prone position.
the study hypothesize is: plethysmographic variability index (PVI) based fluid management is more accurate than conventional method in preventing hypovolemia ana hypotension associated with prone position.
The patients will be randomly assigned into two equal groups using computer-generated random numbers with closed envelop, each of which will include 33 patients.
Group conventional: (n=33) patients are in the conventional fluid management group.
Group PVI: (n=33) patients are in the PVI-based goal-directed fluid management group.
- Being tested
- General anaesthesia, Conventional fluid managment, PVI dependant goal directed fluid therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
General anaesthesiaProcedure or surgery
All patients in supine position will receive breathing 100% oxygen, induction of anaesthesia will be achieved using propofol (2 mg/Kg), 1-2 mcg/kg of fentanyl and atracurium (0.5 mg/Kg). Endotracheal tube will be inserted after 3 minutes of mask ventilation. Patients who will experience prolonged airway instrumentation due to a difficult intubation will be excluded from further data analysis because of excessive stimulation. Then mechanical ventilation will be performed using a tidal volume of 6-8 mL/kg of ideal body weight at an inspiratory to expiratory ratio of 1:2 without positive end-expiratory pressure. The ventilatory frequency will be adjusted to maintain an end-tidal carbon dioxide tension of 35-40 mmHg.
Anaesthesia will be maintained by isoflurane (1-1.5%), atracurium 10 mg intravenous increments every 20 minutes and morphine 0.1 mg/kg intravenous will be given as a long acting analgesia.
Conventional fluid managmentDrug
Ringer solution at the dose of 5 ml/kg/h infused throughout the surgical procedure by taking the parameters such as Heart rate (HR), mean arterial pressure (MAP) and urine output, Hypotension was defined as a condition in which the MAP was below 30% of the baseline MAP of the patient. In this case, bolus of 250 ml crystalloids (0.9% NaCl) was given and in case of hypotension persistence, 5 mg I.V. ephedrine administered and repeated every 5 min till the MAP increased over 70% of baseline.
PVI dependant goal directed fluid therapyDrug
After the induction of anesthesia, Ringer solution infused at the dose of 2 ml/kg/h started as a basal rate of infusion. If the PVI was higher than 13% for more than 5 min, a 250-ml bolus of crystalloids administrated. If the PVI was still higher than 13% after the bolus, it was repeated every 5 min until the PVI was less than 13% and if MAP was below 30% of the baseline MAP of the patient 5 mg iv ephedrine was applied and repeated every 5 min to keep the MAP increased over 70% of baseline.
In the cases where PVI was less than < 13% and if MAP was below 30% of the baseline MAP of the patient 5 mg iv ephedrine was applied and repeated every 5 min to keep the MAP increased over 70% of baseline.
Then the patient was turned to prone position and the same steps according to Massimo readings were repeated.
| Study group | Role | What they receive |
|---|---|---|
| Group conventional | Active comparator | Not described Receives: Procedure: General anaesthesia; Drug: Conventional fluid managment |
| Group PVI | Experimental | Not described Receives: Procedure: General anaesthesia; Drug: PVI dependant goal directed fluid therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The total intraoperative crystalloid consumption
the total volume of infused crystalloids intraoperatively.
Measured: 3 hours
Secondary outcomes (7)
Plethysmographic variability index
measured every 5 minutes intraoperatively taking in consideration these time points: in supine position in the operating room before induction of anaesthesia as a baseline reading (T0) -postinduction reading (T1) -after prone positioning(T2). Then every 30 minutes all through the operation.
Measured: 3 hours
perfusion index
measured every 5 minutes intraoperatively taking in consideration these time points: in supine position in the operating room before induction of anaesthesia as a baseline reading (T0) -postinduction reading (T1) -after prone positioning(T2). Then every 30 minutes all through the operation.
Measured: 3 hours
mean arterial blood pressure
measured every 5 minutes intraoperatively taking in consideration these time points: in supine position in the operating room before induction of anaesthesia as a baseline reading (T0) -postinduction reading (T1) -after prone positioning(T2). Then every 30 minutes all through the operation.
Measured: 3 hours
Heart rate
measured every 5 minutes intraoperatively taking in consideration these time points: in supine position in the operating room before induction of anaesthesia as a baseline reading (T0) -postinduction reading (T1) -after prone positioning(T2). Then every 30 minutes all through the operation.
Measured: 3 hours
Blood lactate level
It will be obtained after induction of anaesthesia (T1) and immediately postoperative in the recovery room (T2).
Measured: 3 hours
Total amount of intraoperative urine output
- Oliguria (defined as a condition in which the intraoperative urine output < 0.5ml/kg/hr) will be recorded every hour and treated by boluses of 250 ml crystalloids (0.9% NaCl).
Measured: 3 hours
The need and the amount of intraoperative blood transfusion
- The total amount of blood loss will be monitored and if exceed 20% of total blood volume blood transfusion will be started at a dose according to the estimated blood loss.
Measured: 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2022
- Study start24 Jan 2022
- Primary completion24 Aug 2022
- Study completion30 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Fluid Management During Elective Spine SurgeriesStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bassant M. Abdelhamid, Cairo University
- Investigators
- Bassant M Abdelhamid, MD, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05239286
- Sponsor's protocol ID
- MD-179-2020
- Status last verified
- Oct 2022
- First submitted
- 21 Jan 2022
- Last updated
- 10 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cesur S, Cardakozu T, Kus A, Turkyilmaz N, Yavuz O. Comparison of conventional fluid management with PVI-based goal-directed fluid management in elective colorectal surgery. J Clin Monit Comput. 2019 Apr;33(2):249-257. doi: 10.1007/s10877-018-0163-y. Epub 2018 Jun 14.
PubMed 29948666McDermid RC, Raghunathan K, Romanovsky A, Shaw AD, Bagshaw SM. Controversies in fluid therapy: Type, dose and toxicity. World J Crit Care Med. 2014 Feb 4;3(1):24-33. doi: 10.5492/wjccm.v3.i1.24. eCollection 2014 Feb 4.
PubMed 24834399Coutrot M, Joachim J, Depret F, Millasseau S, Nougue H, Mateo J, Mebazaa A, Gayat E, Vallee F. Noninvasive continuous detection of arterial hypotension during induction of anaesthesia using a photoplethysmographic signal: proof of concept. Br J Anaesth. 2019 May;122(5):605-612. doi: 10.1016/j.bja.2019.01.037. Epub 2019 Mar 11.
PubMed 30916032Abdelhamid B, Matta M, Rady A, Adel G, Gamal M. Conventional fluid management versus plethysmographic variability index-based goal directed fluid management in patients undergoing spine surgery in the prone position - a randomised control trial. Anaesthesiol Intensive Ther. 2023;55(3):186-195. doi: 10.5114/ait.2023.130792.
PubMed 37728446
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Conventional Fluid Management and Plethysmographic Variability Index Based Goal Directed Fluid Management in Patients Undergoing Spine Surgeries in Prone Position; A Randomized Control Trial.
- ClinicalTrials.gov ID
- NCT05239286
- Acronym / sponsor ID
- MD-179-2020
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 24 Jan 2022 (actual)
- Primary completion
- 24 Aug 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 14 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Plethysmographic variability index is a dynamic method for evaluation of volume status which depends on estimation of respiratory variations in pulse oximeter waveform amplitude. The PVI has been studied in various patient populations and clinical settings, and has been shown to reliably predict fluid responsiveness and guide fluid resuscitation.
conventional fluid management. Fluid replacement is managed according to clinical assessment, heart rate, arterial blood pressure and central venous pressure monitoring. However, clinical studies indicate that changes in ABP cannot be used for the monitoring of stroke volume and cardiac output. Another method is the goal-directed fluid management and it is based on individualized fluid management using static and dynamic parameters.
Detailed description
This study aims to compare the conventional fluid managment and Plethysmographic Variability index based during elective spine surgeries in prone position.
the study hypothesize is: plethysmographic variability index (PVI) based fluid management is more accurate than conventional method in preventing hypovolemia ana hypotension associated with prone position.
The patients will be randomly assigned into two equal groups using computer-generated random numbers with closed envelop, each of which will include 33 patients.
Group conventional: (n=33) patients are in the conventional fluid management group.
Group PVI: (n=33) patients are in the PVI-based goal-directed fluid management group.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group conventional | Active comparator | Procedure: General anaesthesia, Drug: Conventional fluid managment |
| Group PVI | Experimental | Procedure: General anaesthesia, Drug: PVI dependant goal directed fluid therapy |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- • Adult patients (18-65 years)
Key exclusion criteria (7 listed)
- • Operations which will last for less than 15 minutes. (e.g.: plate and screw adjustment or incomplete terminated surgery)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| General anaesthesiaAll patients in supine position will receive breathing 100% oxygen, induction of anaesthesia will be achieved using propofol (2 mg/Kg), 1-2 mcg/kg of fentanyl and atracurium (0.5 mg/Kg). Endotracheal tube will be inserted after 3 minutes of mask ventilation. Patients who will experience prolonged airway instrumentation due to a difficult intubation will be excluded from further data analysis because of excessive stimulation. Then mechanical ventilation will be performed using a tidal volume of 6-8 mL/kg of ideal body weight at an inspiratory to expiratory ratio of 1:2 without positive end-expiratory pressure. The ventilatory frequency will be adjusted to maintain an end-tidal carbon dioxide tension of 35-40 mmHg. Anaesthesia will be maintained by isoflurane (1-1.5%), atracurium 10 mg intravenous increments every 20 minutes and morphine 0.1 mg/kg intravenous will be given as a long acting analgesia. | Procedure or surgery | Group PVI, Group conventional |
| Conventional fluid managmentRinger solution at the dose of 5 ml/kg/h infused throughout the surgical procedure by taking the parameters such as Heart rate (HR), mean arterial pressure (MAP) and urine output, Hypotension was defined as a condition in which the MAP was below 30% of the baseline MAP of the patient. In this case, bolus of 250 ml crystalloids (0.9% NaCl) was given and in case of hypotension persistence, 5 mg I.V. ephedrine administered and repeated every 5 min till the MAP increased over 70% of baseline. | Drug | Group conventional |
| PVI dependant goal directed fluid therapyAfter the induction of anesthesia, Ringer solution infused at the dose of 2 ml/kg/h started as a basal rate of infusion. If the PVI was higher than 13% for more than 5 min, a 250-ml bolus of crystalloids administrated. If the PVI was still higher than 13% after the bolus, it was repeated every 5 min until the PVI was less than 13% and if MAP was below 30% of the baseline MAP of the patient 5 mg iv ephedrine was applied and repeated every 5 min to keep the MAP increased over 70% of baseline. In the cases where PVI was less than < 13% and if MAP was below 30% of the baseline MAP of the patient 5 mg iv ephedrine was applied and repeated every 5 min to keep the MAP increased over 70% of baseline. Then the patient was turned to prone position and the same steps according to Massimo readings were repeated. | Drug | Group PVI |
Primary outcome
The total intraoperative crystalloid consumption
Time frame: 3 hours
the total volume of infused crystalloids intraoperatively.
7 secondary outcomes
Plethysmographic variability index
Time frame: 3 hours
perfusion index
Time frame: 3 hours
mean arterial blood pressure
Time frame: 3 hours
Heart rate
Time frame: 3 hours
Blood lactate level
Time frame: 3 hours
Total amount of intraoperative urine output
Time frame: 3 hours
The need and the amount of intraoperative blood transfusion
Time frame: 3 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2022.
- Background: PubMed 29948666Cesur S, Cardakozu T, Kus A, Turkyilmaz N, Yavuz O. Comparison of conventional fluid management with PVI-based goal-directed fluid management in elective colorectal surgery. J Clin Monit Comput. 2019 Apr;33(2):249-257. doi: 10.1007/s10877-018-0163-y. Epub 2018 Jun 14.
- Background: PubMed 24834399McDermid RC, Raghunathan K, Romanovsky A, Shaw AD, Bagshaw SM. Controversies in fluid therapy: Type, dose and toxicity. World J Crit Care Med. 2014 Feb 4;3(1):24-33. doi: 10.5492/wjccm.v3.i1.24. eCollection 2014 Feb 4.
- Background: PubMed 30916032Coutrot M, Joachim J, Depret F, Millasseau S, Nougue H, Mateo J, Mebazaa A, Gayat E, Vallee F. Noninvasive continuous detection of arterial hypotension during induction of anaesthesia using a photoplethysmographic signal: proof of concept. Br J Anaesth. 2019 May;122(5):605-612. doi: 10.1016/j.bja.2019.01.037. Epub 2019 Mar 11.
- Derived from this study: PubMed 37728446Abdelhamid B, Matta M, Rady A, Adel G, Gamal M. Conventional fluid management versus plethysmographic variability index-based goal directed fluid management in patients undergoing spine surgery in the prone position - a randomised control trial. Anaesthesiol Intensive Ther. 2023;55(3):186-195. doi: 10.5114/ait.2023.130792.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bassant M Abdelhamid, MD principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing General anaesthesia, Conventional fluid managment and PVI dependant goal directed fluid therapy in people with Fluid Management During Elective Spine Surgeries, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The total intraoperative crystalloid consumption (time frame: 3 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05239286, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2022.