Prone PositionNCT03890510
The Effect of High vs. Low Fluid Volume on Ocular Parameters in Prone Spine Surgery
A study testing Ringer's Lactate solution and Spine surgery under general Anesthesia in the prone position in people with Prone Position and Blood Volume, run by Huashan Hospital at 1 site in China.
Trial summary
The purpose of this trial is to compare the effect of different fluid volume infusion on ocular parameters in patients undergoing spine surgery in prone position. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Prone Position, Blood Volume, Intraocular Pressure
- What is being tested?
- Ringer's Lactate solution and Spine surgery under general Anesthesia in the prone position
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 97 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2019to 7 Sep 2020
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Scheduled for elective spine surgery in prone position under general anesthesia
- American Society of Anesthesiologists (ASA) physical status I or II
- Have signed consent form
Who cannot join
- History of eye disease or eye surgery
- Pregnancy or breast feeding
- Known Allergy to latex or Ringer's lactate solution
- Hyperlactacidemia，uncontrolled hypertension, diabetes mellitus, arrhythmia, cardiovascular disease，chronic pulmonary disease, swelling of any body part, abnormal of liver or renal function, anemia, etc.
- Body mass index（BMI）>30
- Expected operation time >6 hours
- Estimated Intraoperative hemorrhage >1000ml
- Taking part in other clinical trials in the last 3 months or at present
Trial locations and contacts
1 site in 1 country.
China1 site
Huashan Hospital Fudan University
Shanghai, Shanghai Municipality, 200040
About this study
Official title: Effect of Different Fluid Volume on Ocular Parameters in Patients Undergoing Spine Surgery in Prone Position
The purpose of this trial is to compare the effect of different fluid volume infusion on ocular parameters in patients undergoing spine surgery in prone position.
Read the detailed description
In the prone position, the intraocular pressure and optic nerve sheath diameter increase progressively with time as compared with those in the supine position. Excessive fluid infusion may further increase intraocular pressure and optic nerve sheath diameter. Pulse pressure variation (PPV) is a dynamic index which can effectively assess fluid responsiveness during general anesthesia.Therefore,the investigators have designed a study to compare the effect of different fluid volume infusion guided by low and high PPV indices on intraocular pressure and optic nerve sheath of patients undergoing prone spine surgery with general anesthesia. One group of the patients will receive relatively loose fluid infusion (target value of PPV: 6%-9%),while the other group of the patients will receive limited fluid infusion (target value of PPV: 13%-16%).
- Conditions
- Prone Position, Blood Volume, Intraocular Pressure
- Being tested
- Ringer's Lactate solution, Spine surgery under general Anesthesia in the prone position
- Keywords
- pulse pressure variation, intraocular pressure, optic sheath diameter, spine surgery, prone position
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ringer's Lactate solutionOther
Patients in both groups will receive Ringer's lactate solution continuously during operation with different infusion volume.
Spine surgery under general Anesthesia in the prone positionProcedure or surgery
The surgery, general anesthesia, and the placement of the prone position will be performed according to the standard procedures.
| Study group | Role | What they receive |
|---|---|---|
| Low PPV Group | Active comparator | After anesthesia induction, patients will receive spine surgery under general anesthesia in the prone position. Ringer's lactate solution will be infused at 1ml/（kg·h ） as a basal speed. Ringer's lactate solution at a volume of 250ml will be used as a bolus dose. Repeat bolus doses will be given to maintain PPV at 6~9% when necessary. Intraoptic pressure and optic sheath diameter will be measured at multiple time points. Receives: Other: Ringer's Lactate solution; Procedure: Spine surgery under general Anesthesia in the prone position |
| High PPV Group | Active comparator | After anesthesia induction, patients will receive spine surgery under general anesthesia in the prone position. Ringer's lactate solution will be infused at 1ml/（kg·h ） as a basal speed. Ringer's lactate solution at a volume of 250ml will be used as a bolus dose. Repeat bolus doses will be given to maintain PPV at 13~16% when necessary. Intraoptic pressure and optic sheath diameter will be measured at multiple time points. Receives: Other: Ringer's Lactate solution; Procedure: Spine surgery under general Anesthesia in the prone position |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change of intraocular pressure
Intraocular pressure will be measured with a TONO-PEN AVIA handheld tonometer.
Measured: 10min after anesthesia induction（supine1）, 10min after prone position(prone1), 1 hour after the prone position(prone2), 2 hour after the prone position(prone3),at the end of the surgery(prone4), and 10min after return to the supine position(supine2).
Secondary outcomes (1)
The change of the optic sheath diameter
The optic sheath diameter will be measured with a Sonocite Portable Ultrasonic System EDGE.
Measured: 10min after anesthesia induction（supine1）, 10min after prone position(prone1), 1 hour after the prone position(prone2), 2 hour after the prone position(prone3),at the end of the surgery(prone4), and 10min after return to the supine position(supine2).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2019
- Study start1 May 2019
- Primary completion31 Aug 2020
- Study completion7 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Prone PositionStudies of the same condition, open and under way.
- More trials run by Huashan HospitalThe 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
- Model description
- Patients will be randomly assigned to the limited fluid infusion group and the loose fluid infusion group.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Huashan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiao-Yu Yang, MD, Huashan Hospital
- Investigators
- Xiaoyu Yang, M.D., Principal investigator, Huashan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03890510
- Sponsor's protocol ID
- FOCUS
- Status last verified
- Dec 2020
- First submitted
- 21 Feb 2019
- Last updated
- 17 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cheng MA, Todorov A, Tempelhoff R, McHugh T, Crowder CM, Lauryssen C. The effect of prone positioning on intraocular pressure in anesthetized patients. Anesthesiology. 2001 Dec;95(6):1351-5. doi: 10.1097/00000542-200112000-00012.
PubMed 11748391Uribe AA, Baig MN, Puente EG, Viloria A, Mendel E, Bergese SD. Current intraoperative devices to reduce visual loss after spine surgery. Neurosurg Focus. 2012 Aug;33(2):E14. doi: 10.3171/2009.8.FOCUS09151.
PubMed 22853832American Society of Anesthesiologists Task Force on Perioperative Visual Loss. Practice advisory for perioperative visual loss associated with spine surgery: an updated report by the American Society of Anesthesiologists Task Force on Perioperative Visual Loss. Anesthesiology. 2012 Feb;116(2):274-85. doi: 10.1097/ALN.0b013e31823c104d. No abstract available.
PubMed 22227790Blecha S, Harth M, Schlachetzki F, Zeman F, Blecha C, Flora P, Burger M, Denzinger S, Graf BM, Helbig H, Pawlik MT. Changes in intraocular pressure and optic nerve sheath diameter in patients undergoing robotic-assisted laparoscopic prostatectomy in steep 45 degrees Trendelenburg position. BMC Anesthesiol. 2017 Mar 11;17(1):40. doi: 10.1186/s12871-017-0333-3.
PubMed 28284189Warner MA. Postoperative visual loss: experts, data, and practice. Anesthesiology. 2006 Oct;105(4):641-2. doi: 10.1097/00000542-200610000-00002. No abstract available.
PubMed 17006056Grant GP, Szirth BC, Bennett HL, Huang SS, Thaker RS, Heary RF, Turbin RE. Effects of prone and reverse trendelenburg positioning on ocular parameters. Anesthesiology. 2010 Jan;112(1):57-65. doi: 10.1097/ALN.0b013e3181c294e1.
PubMed 19996956Lee LA, Roth S, Posner KL, Cheney FW, Caplan RA, Newman NJ, Domino KB. The American Society of Anesthesiologists Postoperative Visual Loss Registry: analysis of 93 spine surgery cases with postoperative visual loss. Anesthesiology. 2006 Oct;105(4):652-9; quiz 867-8. doi: 10.1097/00000542-200610000-00007.
PubMed 17006060Lee LA. Perioperative visual loss and anesthetic management. Curr Opin Anaesthesiol. 2013 Jun;26(3):375-81. doi: 10.1097/ACO.0b013e328360dcd9.
PubMed 23614957Li A, Swinney C, Veeravagu A, Bhatti I, Ratliff J. Postoperative Visual Loss Following Lumbar Spine Surgery: A Review of Risk Factors by Diagnosis. World Neurosurg. 2015 Dec;84(6):2010-21. doi: 10.1016/j.wneu.2015.08.030. Epub 2015 Sep 1.
PubMed 26341434Nandyala SV, Marquez-Lara A, Fineberg SJ, Singh R, Singh K. Incidence and risk factors for perioperative visual loss after spinal fusion. Spine J. 2014 Sep 1;14(9):1866-72. doi: 10.1016/j.spinee.2013.10.026. Epub 2013 Nov 8.
PubMed 24216394Roth S. Perioperative visual loss: what do we know, what can we do? Br J Anaesth. 2009 Dec;103 Suppl 1(Suppl 1):i31-40. doi: 10.1093/bja/aep295.
PubMed 20007988Farag E, Sessler DI, Kovaci B, Wang L, Mascha EJ, Bell G, Kalfas I, Rockwood E, Kurz A. Effects of crystalloid versus colloid and the alpha-2 agonist brimonidine versus placebo on intraocular pressure during prone spine surgery: a factorial randomized trial. Anesthesiology. 2012 Apr;116(4):807-15. doi: 10.1097/ALN.0b013e3182475c10.
PubMed 22322966Yang XY, Wei MM, Tan H, Wang HL, Luo MQ, Xu M, Wang YW. The effect of restrictive vs. liberal fluid protocols on ocular parameters in patients undergoing prone spine surgery: a randomized controlled trial. Perioper Med (Lond). 2023 Jun 12;12(1):23. doi: 10.1186/s13741-023-00310-6.
PubMed 37308905
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Different Fluid Volume on Ocular Parameters in Patients Undergoing Spine Surgery in Prone Position
- ClinicalTrials.gov ID
- NCT03890510
- Acronym / sponsor ID
- FOCUS
- Conditions
- Prone Position, Blood Volume, Intraocular Pressure
- Keywords
- pulse pressure variation, intraocular pressure, optic sheath diameter, spine surgery, prone position
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Huashan HospitalUniversity, hospital or other
- Study start
- 1 May 2019 (actual)
- Primary completion
- 31 Aug 2020 (actual)
- Study completion
- 7 Sep 2020 (actual)
- First posted
- 26 Mar 2019 (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.
The purpose of this trial is to compare the effect of different fluid volume infusion on ocular parameters in patients undergoing spine surgery in prone position.
Detailed description
In the prone position, the intraocular pressure and optic nerve sheath diameter increase progressively with time as compared with those in the supine position. Excessive fluid infusion may further increase intraocular pressure and optic nerve sheath diameter. Pulse pressure variation (PPV) is a dynamic index which can effectively assess fluid responsiveness during general anesthesia.Therefore,the investigators have designed a study to compare the effect of different fluid volume infusion guided by low and high PPV indices on intraocular pressure and optic nerve sheath of patients undergoing prone spine surgery with general anesthesia. One group of the patients will receive relatively loose fluid infusion (target value of PPV: 6%-9%),while the other group of the patients will receive limited fluid infusion (target value of PPV: 13%-16%).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Patients will be randomly assigned to the limited fluid infusion group and the loose fluid infusion group.
| Arm | Type | Receives |
|---|---|---|
| Low PPV Group | Active comparator | Other: Ringer's Lactate solution, Procedure: Spine surgery under general Anesthesia in the prone positionAfter anesthesia induction, patients will receive spine surgery under general anesthesia in the prone position. Ringer's lactate solution will be infused at 1ml/（kg·h ） as a basal speed. Ringer's lactate solution at a volume of 250ml will be used as a bolus dose. Repeat bolus doses will be given to maintain PPV at 6~9% when necessary. Intraoptic pressure and optic sheath diameter will be measured at multiple time points. |
| High PPV Group | Active comparator | Other: Ringer's Lactate solution, Procedure: Spine surgery under general Anesthesia in the prone positionAfter anesthesia induction, patients will receive spine surgery under general anesthesia in the prone position. Ringer's lactate solution will be infused at 1ml/（kg·h ） as a basal speed. Ringer's lactate solution at a volume of 250ml will be used as a bolus dose. Repeat bolus doses will be given to maintain PPV at 13~16% when necessary. Intraoptic pressure and optic sheath diameter will be measured at multiple time points. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Scheduled for elective spine surgery in prone position under general anesthesia
- American Society of Anesthesiologists (ASA) physical status I or II
- Have signed consent form
Key exclusion criteria (8 listed)
- History of eye disease or eye surgery
- Pregnancy or breast feeding
- Known Allergy to latex or Ringer's lactate solution
- Hyperlactacidemia，uncontrolled hypertension, diabetes mellitus, arrhythmia, cardiovascular disease，chronic pulmonary disease, swelling of any body part, abnormal of liver or renal function, anemia, etc.
- Body mass index（BMI）>30
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 |
|---|---|---|
| Ringer's Lactate solutionPatients in both groups will receive Ringer's lactate solution continuously during operation with different infusion volume. | Other | High PPV Group, Low PPV Group |
| Spine surgery under general Anesthesia in the prone positionThe surgery, general anesthesia, and the placement of the prone position will be performed according to the standard procedures. | Procedure or surgery | High PPV Group, Low PPV Group |
Primary outcome
The change of intraocular pressure
Time frame: 10min after anesthesia induction（supine1）, 10min after prone position(prone1), 1 hour after the prone position(prone2), 2 hour after the prone position(prone3),at the end of the surgery(prone4), and 10min after return to the supine position(supine2).
Intraocular pressure will be measured with a TONO-PEN AVIA handheld tonometer.
1 secondary outcome
The change of the optic sheath diameter
Time frame: 10min after anesthesia induction（supine1）, 10min after prone position(prone1), 1 hour after the prone position(prone2), 2 hour after the prone position(prone3),at the end of the surgery(prone4), and 10min after return to the supine position(supine2).
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 17 Dec 2020.
- Background: PubMed 11748391Cheng MA, Todorov A, Tempelhoff R, McHugh T, Crowder CM, Lauryssen C. The effect of prone positioning on intraocular pressure in anesthetized patients. Anesthesiology. 2001 Dec;95(6):1351-5. doi: 10.1097/00000542-200112000-00012.
- Background: PubMed 22853832Uribe AA, Baig MN, Puente EG, Viloria A, Mendel E, Bergese SD. Current intraoperative devices to reduce visual loss after spine surgery. Neurosurg Focus. 2012 Aug;33(2):E14. doi: 10.3171/2009.8.FOCUS09151.
- Background: PubMed 22227790American Society of Anesthesiologists Task Force on Perioperative Visual Loss. Practice advisory for perioperative visual loss associated with spine surgery: an updated report by the American Society of Anesthesiologists Task Force on Perioperative Visual Loss. Anesthesiology. 2012 Feb;116(2):274-85. doi: 10.1097/ALN.0b013e31823c104d. No abstract available.
- Background: PubMed 28284189Blecha S, Harth M, Schlachetzki F, Zeman F, Blecha C, Flora P, Burger M, Denzinger S, Graf BM, Helbig H, Pawlik MT. Changes in intraocular pressure and optic nerve sheath diameter in patients undergoing robotic-assisted laparoscopic prostatectomy in steep 45 degrees Trendelenburg position. BMC Anesthesiol. 2017 Mar 11;17(1):40. doi: 10.1186/s12871-017-0333-3.
- Background: PubMed 17006056Warner MA. Postoperative visual loss: experts, data, and practice. Anesthesiology. 2006 Oct;105(4):641-2. doi: 10.1097/00000542-200610000-00002. No abstract available.
- Background: PubMed 19996956Grant GP, Szirth BC, Bennett HL, Huang SS, Thaker RS, Heary RF, Turbin RE. Effects of prone and reverse trendelenburg positioning on ocular parameters. Anesthesiology. 2010 Jan;112(1):57-65. doi: 10.1097/ALN.0b013e3181c294e1.
- Background: PubMed 17006060Lee LA, Roth S, Posner KL, Cheney FW, Caplan RA, Newman NJ, Domino KB. The American Society of Anesthesiologists Postoperative Visual Loss Registry: analysis of 93 spine surgery cases with postoperative visual loss. Anesthesiology. 2006 Oct;105(4):652-9; quiz 867-8. doi: 10.1097/00000542-200610000-00007.
- Background: PubMed 23614957Lee LA. Perioperative visual loss and anesthetic management. Curr Opin Anaesthesiol. 2013 Jun;26(3):375-81. doi: 10.1097/ACO.0b013e328360dcd9.
- Background: PubMed 26341434Li A, Swinney C, Veeravagu A, Bhatti I, Ratliff J. Postoperative Visual Loss Following Lumbar Spine Surgery: A Review of Risk Factors by Diagnosis. World Neurosurg. 2015 Dec;84(6):2010-21. doi: 10.1016/j.wneu.2015.08.030. Epub 2015 Sep 1.
- Background: PubMed 24216394Nandyala SV, Marquez-Lara A, Fineberg SJ, Singh R, Singh K. Incidence and risk factors for perioperative visual loss after spinal fusion. Spine J. 2014 Sep 1;14(9):1866-72. doi: 10.1016/j.spinee.2013.10.026. Epub 2013 Nov 8.
- Background: PubMed 20007988Roth S. Perioperative visual loss: what do we know, what can we do? Br J Anaesth. 2009 Dec;103 Suppl 1(Suppl 1):i31-40. doi: 10.1093/bja/aep295.
- Results publication: PubMed 22322966Farag E, Sessler DI, Kovaci B, Wang L, Mascha EJ, Bell G, Kalfas I, Rockwood E, Kurz A. Effects of crystalloid versus colloid and the alpha-2 agonist brimonidine versus placebo on intraocular pressure during prone spine surgery: a factorial randomized trial. Anesthesiology. 2012 Apr;116(4):807-15. doi: 10.1097/ALN.0b013e3182475c10.
- Individual participant dataSharing planned: No
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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.
Xiaoyu Yang, M.D. principal investigator
Huashan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ringer's Lactate solution and Spine surgery under general Anesthesia in the prone position in people with Prone Position and Blood Volume, run by Huashan Hospital at 1 site in China.
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 8 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 17 Dec 2020. 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 China. 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 change of intraocular pressure (time frame: 10min after anesthesia induction（supine1）, 10min after prone position(prone1), 1 hour after the prone position(prone2), 2 hour after the prone position(prone3),at the end of the surgery(prone4), and 10min after return to the supine position(supine2).). 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 NCT03890510, which also lists 13 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 17 Dec 2020.