IrrigationPhase 1NCT05161780
Evaluation of Endoscopic Surgical Field Clarity Using Hot Saline Versus Lactated Ringer's Irrigation
A Phase 1 study testing Lactated Ringer's Irrigation and Normal Saline in people with Irrigation, run by Carl Snyderman at 1 site in United States.
Trial summary
This study is designed to determine whether Normal Saline or Lactated Ringer's irrigation is superior in maintaining superior endoscopic surgical field clarity in surgery for pituitary adenoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Irrigation
- What is being tested?
- Lactated Ringer's Irrigation and Normal Saline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Feb 2022to 13 Jun 2024
- Phase
- Phase 1
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Any patient with a primary pituitary adenoma, macro or micro adenoma.
Who cannot join
- Age <18
- Pregnancy
- Revision surgery
- Non-surgical candidate due to medical, surgical, or anesthesia contraindications
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
About this study
This study is designed to determine whether Normal Saline or Lactated Ringer's irrigation is superior in maintaining superior endoscopic surgical field clarity in surgery for pituitary adenoma.
Read the detailed description
The aims of this study are to determine whether the endoscopic surgical view is objectively clearer using Normal Saline versus Lactated Ringer's Irrigation during endoscopic skull base surgery for pituitary adenoma. Other objectives include determining whether lactated Ringer's irrigation decreases total estimated blood loss and whether use of lactated Ringer's irrigation shortens surgical time.
Hot saline irrigation at 40 degrees Celcius has been shown to improve endoscopic surgical field clarity and its use is common practice in both endoscopic inflammatory sinus surgeries and skull base procedures. Saline irrigation dilutes blood in the surgical field keeping the endoscopic view clean and more bloodless and the elevated temperature promotes hemostasis.
Preliminary evidence suggests that the use of calcium-containing irrigant may further improve endoscopic surgical views. This mechanism is thought to be mediated through the activation of platelets and providing a calcium source to calcium-dependent factors in the coagulation cascade thereby promoting hemostasis. Using lactated Ringer's, a calcium-containing fluid, may result in improved surgeon visualization, decreased blood loss, and decreased complications during endoscopic approaches to the skull base.
- Conditions
- Irrigation
- Being tested
- Lactated Ringer's Irrigation, Normal Saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactated Ringer's IrrigationDrug
Lactated Ringers at 40C will be used for the entirety of the surgery including the approach and exposure of the tumor as well as tumor resection, After surgery, two blinded skull base surgeon reviewers will rate the clarity of the endoscopic field of view at the recorded intervals. The surgical field will be graded using a widely accepted numeric integer (Boezaart) scale.
Normal SalineDrug
Normal Saline at 40C will be used for the entirety of the surgery including the approach and exposure of the tumor as well as tumor resection, After surgery, two blinded skull base surgeon reviewers will rate the clarity of the endoscopic field of view at the recorded intervals. The surgical field will be graded using a widely accepted numeric integer (Boezaart) scale.
| Study group | Role | What they receive |
|---|---|---|
| Normal Saline | Active comparator | This study will be a prospective double blinded randomized controlled trial. Fifteen patients will be randomly assigned to the normal saline group using a random number generator. Receives: Drug: Normal Saline |
| Lactated Ringer's Irrigation | Experimental | This study will be a prospective double blinded randomized controlled trial. Fifteen patients will be randomly assigned to the lactated reinger group using a random number generator. Receives: Drug: Lactated Ringer's Irrigation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Boezaart scale rating video clips
Rating for each of the three recorded video clips per patient following tumor ablation. The Boezaart is an ordinal scale 0 = No bleeding 1 = Minimal bleeding: Not a surgical nuisance and no suction required 2 = Mild bleeding: Occasional suction required, but does not affect dissection 3 = Moderate bleeding: Slightly compromises surgical field, frequent suction required 4 = Severe bleeding: Significantly compromises surgical field, frequent suction required, bleeding threat field just after removal of suction 5 = Massive bleeding: Prevent dissection.
Measured: 10 minutes
Boezaart scale rating video clips
rating for each of the three recorded video clips per patient after 10 minutes of irrigation. The Boezaart is an ordinal scale 0 = No bleeding 1 = Minimal bleeding: Not a surgical nuisance and no suction required 2 = Mild bleeding: Occasional suction required, but does not affect dissection 3 = Moderate bleeding: Slightly compromises surgical field, frequent suction required 4 = Severe bleeding: Significantly compromises surgical field, frequent suction required, bleeding threat field just after removal of suction 5 = Massive bleeding: Prevent dissection.
Measured: 10 minutes
Boezaart scale rating video clips
rating for each of the three recorded video clips per patient at the completion of hemostasis. The Boezaart is an ordinal scale 0 = No bleeding 1 = Minimal bleeding: Not a surgical nuisance and no suction required 2 = Mild bleeding: Occasional suction required, but does not affect dissection 3 = Moderate bleeding: Slightly compromises surgical field, frequent suction required 4 = Severe bleeding: Significantly compromises surgical field, frequent suction required, bleeding threat field just after removal of suction 5 = Massive bleeding: Prevent dissection..
Measured: 10 minutes
Time
Time between tumor ablation and the completion of hemostasis, or total irrigation time for patients undergoing normal saline or Lactated Ringer's irrigation during their surgical case.
Measured: 10 minutes
Secondary outcomes (1)
Estimated Blood Loss (EBL)
(EBL) per case and total operative time
Measured: 15 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2021
- Study start9 Feb 2022
- Primary completion13 Jun 2024
- Study completion13 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IrrigationStudies of the same condition, open and under way.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Participants will consist of 30 patients undergoing skull base surgery for a Pituitary Adenoma. This study will be a prospective double blinded randomized controlled trial examining the efficacy of normal saline versus Lactated Ringer's in achieving clarity of the surgical field during endoscopic skull base surgery.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Carl Snyderman
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Carl Snyderman, University of Pittsburgh
- Investigators
- Carl Snyderman, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05161780
- Sponsor's protocol ID
- STUDY21110081
- Status last verified
- Nov 2024
- First submitted
- 2 Dec 2021
- Last updated
- 12 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Endoscopic Surgical Field Clarity Using Hot Saline Versus Lactated Ringer's Irrigation
- ClinicalTrials.gov ID
- NCT05161780
- Acronym / sponsor ID
- STUDY21110081
- Conditions
- Irrigation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Carl SnydermanUniversity, hospital or other
- Study start
- 9 Feb 2022 (actual)
- Primary completion
- 13 Jun 2024 (actual)
- Study completion
- 13 Jun 2024 (actual)
- First posted
- 17 Dec 2021 (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.
This study is designed to determine whether Normal Saline or Lactated Ringer's irrigation is superior in maintaining superior endoscopic surgical field clarity in surgery for pituitary adenoma.
Detailed description
The aims of this study are to determine whether the endoscopic surgical view is objectively clearer using Normal Saline versus Lactated Ringer's Irrigation during endoscopic skull base surgery for pituitary adenoma. Other objectives include determining whether lactated Ringer's irrigation decreases total estimated blood loss and whether use of lactated Ringer's irrigation shortens surgical time.
Hot saline irrigation at 40 degrees Celcius has been shown to improve endoscopic surgical field clarity and its use is common practice in both endoscopic inflammatory sinus surgeries and skull base procedures. Saline irrigation dilutes blood in the surgical field keeping the endoscopic view clean and more bloodless and the elevated temperature promotes hemostasis.
Preliminary evidence suggests that the use of calcium-containing irrigant may further improve endoscopic surgical views. This mechanism is thought to be mediated through the activation of platelets and providing a calcium source to calcium-dependent factors in the coagulation cascade thereby promoting hemostasis. Using lactated Ringer's, a calcium-containing fluid, may result in improved surgeon visualization, decreased blood loss, and decreased complications during endoscopic approaches to the skull base.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Participants will consist of 30 patients undergoing skull base surgery for a Pituitary Adenoma. This study will be a prospective double blinded randomized controlled trial examining the efficacy of normal saline versus Lactated Ringer's in achieving clarity of the surgical field during endoscopic skull base surgery.
| Arm | Type | Receives |
|---|---|---|
| Normal Saline | Active comparator | Drug: Normal SalineThis study will be a prospective double blinded randomized controlled trial. Fifteen patients will be randomly assigned to the normal saline group using a random number generator. |
| Lactated Ringer's Irrigation | Experimental | Drug: Lactated Ringer's IrrigationThis study will be a prospective double blinded randomized controlled trial. Fifteen patients will be randomly assigned to the lactated reinger group using a random number generator. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Any patient with a primary pituitary adenoma, macro or micro adenoma.
Key exclusion criteria (4 listed)
- Age <18
- Pregnancy
- Revision surgery
- Non-surgical candidate due to medical, surgical, or anesthesia contraindications
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 |
|---|---|---|
| Lactated Ringer's IrrigationLactated Ringers at 40C will be used for the entirety of the surgery including the approach and exposure of the tumor as well as tumor resection, After surgery, two blinded skull base surgeon reviewers will rate the clarity of the endoscopic field of view at the recorded intervals. The surgical field will be graded using a widely accepted numeric integer (Boezaart) scale. | Drug | Lactated Ringer's Irrigation |
| Normal SalineNormal Saline at 40C will be used for the entirety of the surgery including the approach and exposure of the tumor as well as tumor resection, After surgery, two blinded skull base surgeon reviewers will rate the clarity of the endoscopic field of view at the recorded intervals. The surgical field will be graded using a widely accepted numeric integer (Boezaart) scale. | Drug | Normal Saline |
Primary outcome
Boezaart scale rating video clips
Time frame: 10 minutes
Rating for each of the three recorded video clips per patient following tumor ablation. The Boezaart is an ordinal scale 0 = No bleeding 1 = Minimal bleeding: Not a surgical nuisance and no suction required 2 = Mild bleeding: Occasional suction required, but does not affect dissection 3 = Moderate bleeding: Slightly compromises surgical field, frequent suction required 4 = Severe bleeding: Significantly compromises surgical field, frequent suction required, bleeding threat field just after removal of suction 5 = Massive bleeding: Prevent dissection.
Boezaart scale rating video clips
Time frame: 10 minutes
rating for each of the three recorded video clips per patient after 10 minutes of irrigation. The Boezaart is an ordinal scale 0 = No bleeding 1 = Minimal bleeding: Not a surgical nuisance and no suction required 2 = Mild bleeding: Occasional suction required, but does not affect dissection 3 = Moderate bleeding: Slightly compromises surgical field, frequent suction required 4 = Severe bleeding: Significantly compromises surgical field, frequent suction required, bleeding threat field just after removal of suction 5 = Massive bleeding: Prevent dissection.
Boezaart scale rating video clips
Time frame: 10 minutes
rating for each of the three recorded video clips per patient at the completion of hemostasis. The Boezaart is an ordinal scale 0 = No bleeding 1 = Minimal bleeding: Not a surgical nuisance and no suction required 2 = Mild bleeding: Occasional suction required, but does not affect dissection 3 = Moderate bleeding: Slightly compromises surgical field, frequent suction required 4 = Severe bleeding: Significantly compromises surgical field, frequent suction required, bleeding threat field just after removal of suction 5 = Massive bleeding: Prevent dissection..
Time
Time frame: 10 minutes
Time between tumor ablation and the completion of hemostasis, or total irrigation time for patients undergoing normal saline or Lactated Ringer's irrigation during their surgical case.
1 secondary outcome
Estimated Blood Loss (EBL)
Time frame: 15 min
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 12 Nov 2024.
- 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.
Carl Snyderman, MD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Lactated Ringer's Irrigation and Normal Saline in people with Irrigation, run by Carl Snyderman at 1 site in United States.
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 1 inclusion and 4 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 12 Nov 2024. 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 United States. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Boezaart scale rating video clips (time frame: 10 minutes). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Nov 2024.