RhinosinusitisNCT06343493
Effect of Hot Saline Irrigation on the Operative Field During Endoscopic Sinus Surgery
A study testing Normal saline heated up to 50 °C in people with Rhinosinusitis, run by Rawalpindi Medical College at 1 site in Pakistan.
Trial summary
Control of bleeding is very important during endoscopic sinus surgery. Saline heated up to 50°C causes dilatation of vessels and edema without nasal mucosa necrosis. It also promotes the clotting cascade so helps in having a bloodless procedure. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Rhinosinusitis
- What is being tested?
- Normal saline heated up to 50 °C
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 16 Jun 2023to 31 Dec 2023
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- All patients with chronic rhinosinusitis requiring surgery
Who cannot join
- Unilateral disease
- Suspicion of malignancy
- CSF leak
- Bleeding diathesis
- Significant comorbidities
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Hot Saline Irrigation on the Operative Field During Endoscopic Sinus Surgery: A Randomized Controlled Trial
Control of bleeding is very important during endoscopic sinus surgery. Saline heated up to 50°C causes dilatation of vessels and edema without nasal mucosa necrosis. It also promotes the clotting cascade so helps in having a bloodless procedure.
This randomized controlled trial was conducted on 60 patients divided into two groups (30 each). Group A was the interventional group in which patients were irrigated with saline of 50°C during surgery. Group B was the control group where room temperature saline was used. Operative field was assessed using the Boezaart score, duration of surgery and bleeding in ml.
KEY WORDS:
- Chronic rhinosinusitis (CRS)
- Endoscopic sinus surgery
- Boezaart score
Read the detailed description
INTRODUCTION: Chronic rhinosinsusitis is an inflammatory disease of the sinonasal mucosa lasting for more than 12 weeks. Endoscopic sinus surgery is the surgical procedure used to treat recalcitrant chronic rhinosinusitis. It not only helps in the drainage of sinuses and removal of pathology but also prevents the disturbance of anatomy and formation of facial scars. Control of bleeding during the procedure is a test for surgeons as well as anesthetists. Capillaries are the commonest vessels to bleed during the surgery so that's why mean arterial pressure is an important determinant of the severity of bleeding. A good control of bleeding gives a good visualization of the anatomy during the procedure.
There are different ways to reduce bleeding but all carry side effects too. Topical vasoconstrictors may also be absorbed systemically so must be used carefully in children and patients with cardiac ischemia. Moreover, there's no accurate way to measure absorption of a vasoconstrictor so it's difficult to recommend a safe dose for a particular patient. Cautery which is used to seal blood vessels is also associated with pain as well as mucosal damage. Anesthesia induced hypotension is also not appropriate for all patients as it results in decreased oxygen supply to various vitals organs of the body.
Normal saline heated up to 50°C causes dilatation of vessels and nasal edema without causing nasal mucosa necrosis. This edema compresses blood vessels and helps in controlling bleeding. It also promotes the clotting cascade. In addition, it provides better visualization of the surgical field by reduction of fog formation. A study conducted by Shehata A et al. showed a significant improvement in the operative field when normal saline at 50° C was used during endoscopic sinus surgery. Not only the operative filed was improved, also the duration of surgery was significantly reduced. According to the results of this study, saline heated up to 50°C used for the irrigation of endoscopic sinus surgery produced a result comparable to usage of tranexamic acid with a significant p value. Another study by Ranford D et al. concluded that irrigation with heated saline during endoscopic sinus surgery reduced bleeding by 20 percent.
This study aims to assess the effect of heated normal saline up to 50°C upon the operative field during endoscopic sinus surgery. The use of hot saline for irrigation during endoscopic sinus surgery can prove to be a cost effective method to have a bloodless field during surgery.
METHODS AND MATERIALS:
This randomized controlled trial was conducted after approval from the ethical board in the setting of department of ENT and head \& neck surgery, Benazir Bhutto Hospital, Rawalpindi over a period of ten months from June 2023 to Dec 2023. The sampling technique was simple random sampling. The patients were divided into two groups (treatment group and control group) via randomization using the lottery method. Sample size came out to be 60, with 30 patients in each group. Proper written consents taken from the patients and the surgery was done in the ENT operation theatre by a surgeon with an experience of more than 5 years.
Patient with bilateral chronic rhinosinusitis and pansinusitis on plain CT scan nose and paranasal sinuses were included in the study. Patients with unilateral disease, uncontrolled hypertension, diabetes or other significant comorbidities were excluded. Moreover, patients with the suspicion of malignancy, CSF leak and bleeding diathesis affecting the results were also not included in the study. Group A was the interventional group in which normal saline heated up to 50°C was irrigated during surgery. Normal saline was heated in a boiler and a temperature of 50°C was continuously maintained and monitored. Mean arterial pressure appropriate for endoscopic sinus surgery was controlled by the anesthetist using different drugs for hypotensive anesthesia and it was recorded after every 15 minutes. Intra-operative blood loss was measured from the glass suction tank after subtraction of the irrigated normal saline.
The patient, operating surgeon and primary investigator were blinded during the study to prevent bias. To assess the operative field, subjective grading was done by the surgeon using the Boezaart score. Wait and watch approach was followed to assess bleeding control. Total duration of surgery was also recorded. At the end of the surgery, bilateral anterior nasal packing was done.
ANALYSIS PLAN:
The data was analysed by SPSS version 26. Quantitative data was expressed as mean and standard deviation. Qualitative data was represented as frequencies and percentages. Independent sample T tests was used for the quantitative data analysis. Moreover different correlations were done via Spearman and Kendall test. A P value of <0.05 was considered as significant and a P value of <0.001 showed a high significance.
- Conditions
- Rhinosinusitis
- Being tested
- Normal saline heated up to 50 °C
- Keywords
- Endoscopic sinus surgery, Operative field, Saline
- Medical subject headings
- Rhinosinusitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Normal saline heated up to 50 °CDrug
Also called NaCl 0.9%
Saline heated up to 50 °C used for irrigation
| Study group | Role | What they receive |
|---|---|---|
| Group A (Interventional Group) | Experimental | Hot saline with a temperature of 50°C used for irrigation during endoscopic sinus surgery. Frequency of the drug is according to the operative field and surgeon's need. Receives: Drug: Normal saline heated up to 50 °C |
| Group B (Control Group) | No intervention | Saline at room temperature used for irrigation during endoscopic sinus surgery. Frequency according to the operative field and surgeon's need. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Boezaart Score
Operative field is assessed based on the Boezaart score which is a subjective score graded from 0 to 5 where 0 shows no bleeding and is the minimum score. 5 is the maximum score which shows severe bleeding. So the outcome worsens as the grade becomes higher from 0 to 5. 5 shows the worst outcome.
Measured: Per operative
Secondary outcomes (2)
Bleeding in ml
Operative field assessed on the basis of blood loss in ml measured from the suction tanks after subtracting the irrigated saline volume
Measured: Per operative
Duration of Surgery
If the operative field is good, duration of surgery is decreased and vice versa
Measured: From the start of surgery to the end (per operative)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2024
- Study start16 Jun 2023
- Primary completion15 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for RhinosinusitisStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rawalpindi Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, JAWAIRIA ALTAF, Rawalpindi Medical College
- Investigators
- Jawairia Altaf PGR, Principal investigator, Rawalpindi Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06343493
- Sponsor's protocol ID
- JALTAF
- Status last verified
- Mar 2024
- First submitted
- 17 Mar 2024
- Last updated
- 2 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ranford D, Fu B, Surda P, Rudd J. Hot saline irrigation for haemostasis in functional endoscopic sinus surgery: a systematic review and meta-analysis. J Laryngol Otol. 2022 Aug;136(8):676-682. doi: 10.1017/S0022215121003698. Epub 2021 Nov 25.
PubMed 34819186Dalziel K, Stein K, Round A, Garside R, Royle P. Endoscopic sinus surgery for the excision of nasal polyps: A systematic review of safety and effectiveness. Am J Rhinol. 2006 Sep-Oct;20(5):506-19. doi: 10.2500/ajr.2006.20.2923.
PubMed 17063747Senior BA, Kennedy DW, Tanabodee J, Kroger H, Hassab M, Lanza D. Long-term results of functional endoscopic sinus surgery. Laryngoscope. 1998 Feb;108(2):151-7. doi: 10.1097/00005537-199802000-00001.
PubMed 9473061
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Hot Saline Irrigation on the Operative Field During Endoscopic Sinus Surgery: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06343493
- Acronym / sponsor ID
- JALTAF
- Conditions
- Rhinosinusitis
- Keywords
- Endoscopic sinus surgery, Operative field, Saline
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Rawalpindi Medical CollegeUniversity, hospital or other
- Study start
- 16 Jun 2023 (actual)
- Primary completion
- 15 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 2 Apr 2024 (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.
Control of bleeding is very important during endoscopic sinus surgery. Saline heated up to 50°C causes dilatation of vessels and edema without nasal mucosa necrosis. It also promotes the clotting cascade so helps in having a bloodless procedure.
This randomized controlled trial was conducted on 60 patients divided into two groups (30 each). Group A was the interventional group in which patients were irrigated with saline of 50°C during surgery. Group B was the control group where room temperature saline was used. Operative field was assessed using the Boezaart score, duration of surgery and bleeding in ml.
KEY WORDS:
- Chronic rhinosinusitis (CRS)
- Endoscopic sinus surgery
- Boezaart score
Detailed description
INTRODUCTION: Chronic rhinosinsusitis is an inflammatory disease of the sinonasal mucosa lasting for more than 12 weeks. Endoscopic sinus surgery is the surgical procedure used to treat recalcitrant chronic rhinosinusitis. It not only helps in the drainage of sinuses and removal of pathology but also prevents the disturbance of anatomy and formation of facial scars. Control of bleeding during the procedure is a test for surgeons as well as anesthetists. Capillaries are the commonest vessels to bleed during the surgery so that's why mean arterial pressure is an important determinant of the severity of bleeding. A good control of bleeding gives a good visualization of the anatomy during the procedure.
There are different ways to reduce bleeding but all carry side effects too. Topical vasoconstrictors may also be absorbed systemically so must be used carefully in children and patients with cardiac ischemia. Moreover, there's no accurate way to measure absorption of a vasoconstrictor so it's difficult to recommend a safe dose for a particular patient. Cautery which is used to seal blood vessels is also associated with pain as well as mucosal damage. Anesthesia induced hypotension is also not appropriate for all patients as it results in decreased oxygen supply to various vitals organs of the body.
Normal saline heated up to 50°C causes dilatation of vessels and nasal edema without causing nasal mucosa necrosis. This edema compresses blood vessels and helps in controlling bleeding. It also promotes the clotting cascade. In addition, it provides better visualization of the surgical field by reduction of fog formation. A study conducted by Shehata A et al. showed a significant improvement in the operative field when normal saline at 50° C was used during endoscopic sinus surgery. Not only the operative filed was improved, also the duration of surgery was significantly reduced. According to the results of this study, saline heated up to 50°C used for the irrigation of endoscopic sinus surgery produced a result comparable to usage of tranexamic acid with a significant p value. Another study by Ranford D et al. concluded that irrigation with heated saline during endoscopic sinus surgery reduced bleeding by 20 percent.
This study aims to assess the effect of heated normal saline up to 50°C upon the operative field during endoscopic sinus surgery. The use of hot saline for irrigation during endoscopic sinus surgery can prove to be a cost effective method to have a bloodless field during surgery.
METHODS AND MATERIALS:
This randomized controlled trial was conducted after approval from the ethical board in the setting of department of ENT and head \& neck surgery, Benazir Bhutto Hospital, Rawalpindi over a period of ten months from June 2023 to Dec 2023. The sampling technique was simple random sampling. The patients were divided into two groups (treatment group and control group) via randomization using the lottery method. Sample size came out to be 60, with 30 patients in each group. Proper written consents taken from the patients and the surgery was done in the ENT operation theatre by a surgeon with an experience of more than 5 years.
Patient with bilateral chronic rhinosinusitis and pansinusitis on plain CT scan nose and paranasal sinuses were included in the study. Patients with unilateral disease, uncontrolled hypertension, diabetes or other significant comorbidities were excluded. Moreover, patients with the suspicion of malignancy, CSF leak and bleeding diathesis affecting the results were also not included in the study. Group A was the interventional group in which normal saline heated up to 50°C was irrigated during surgery. Normal saline was heated in a boiler and a temperature of 50°C was continuously maintained and monitored. Mean arterial pressure appropriate for endoscopic sinus surgery was controlled by the anesthetist using different drugs for hypotensive anesthesia and it was recorded after every 15 minutes. Intra-operative blood loss was measured from the glass suction tank after subtraction of the irrigated normal saline.
The patient, operating surgeon and primary investigator were blinded during the study to prevent bias. To assess the operative field, subjective grading was done by the surgeon using the Boezaart score. Wait and watch approach was followed to assess bleeding control. Total duration of surgery was also recorded. At the end of the surgery, bilateral anterior nasal packing was done.
ANALYSIS PLAN:
The data was analysed by SPSS version 26. Quantitative data was expressed as mean and standard deviation. Qualitative data was represented as frequencies and percentages. Independent sample T tests was used for the quantitative data analysis. Moreover different correlations were done via Spearman and Kendall test. A P value of <0.05 was considered as significant and a P value of <0.001 showed a high significance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A (Interventional Group) | Experimental | Drug: Normal saline heated up to 50 °CHot saline with a temperature of 50°C used for irrigation during endoscopic sinus surgery. Frequency of the drug is according to the operative field and surgeon's need. |
| Group B (Control Group) | No intervention | –Saline at room temperature used for irrigation during endoscopic sinus surgery. Frequency according to the operative field and surgeon's need. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All patients with chronic rhinosinusitis requiring surgery
Key exclusion criteria (5 listed)
- Unilateral disease
- Suspicion of malignancy
- CSF leak
- Bleeding diathesis
- Significant comorbidities
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 |
|---|---|---|
| Normal saline heated up to 50 °CAlso: NaCl 0.9%Saline heated up to 50 °C used for irrigation | Drug | Group A (Interventional Group) |
Primary outcome
Boezaart Score
Time frame: Per operative
Operative field is assessed based on the Boezaart score which is a subjective score graded from 0 to 5 where 0 shows no bleeding and is the minimum score. 5 is the maximum score which shows severe bleeding. So the outcome worsens as the grade becomes higher from 0 to 5. 5 shows the worst outcome.
2 secondary outcomes
Bleeding in ml
Time frame: Per operative
Duration of Surgery
Time frame: From the start of surgery to the end (per operative)
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 2 Apr 2024.
- Results publication: PubMed 34819186Ranford D, Fu B, Surda P, Rudd J. Hot saline irrigation for haemostasis in functional endoscopic sinus surgery: a systematic review and meta-analysis. J Laryngol Otol. 2022 Aug;136(8):676-682. doi: 10.1017/S0022215121003698. Epub 2021 Nov 25.
- Results publication: PubMed 17063747Dalziel K, Stein K, Round A, Garside R, Royle P. Endoscopic sinus surgery for the excision of nasal polyps: A systematic review of safety and effectiveness. Am J Rhinol. 2006 Sep-Oct;20(5):506-19. doi: 10.2500/ajr.2006.20.2923.
- Results publication: PubMed 9473061Senior BA, Kennedy DW, Tanabodee J, Kroger H, Hassab M, Lanza D. Long-term results of functional endoscopic sinus surgery. Laryngoscope. 1998 Feb;108(2):151-7. doi: 10.1097/00005537-199802000-00001.
- 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.
Jawairia Altaf PGR principal investigator
Rawalpindi Medical College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Normal saline heated up to 50 °C in people with Rhinosinusitis, run by Rawalpindi Medical College at 1 site in Pakistan.
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 5 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 2 Apr 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 Pakistan. 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?
Boezaart Score (time frame: Per operative). 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 NCT06343493, which also lists 3 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 2 Apr 2024.