Rhinosinusitis ChronicNCT07627789
This Study Aims to Assess the Impact of 50°C Saline Irrigation on the Overall Intraoperative Blood Loss and Surgical Visualization During Endoscopic Sinus Surgery for Rhinosinusitis.
A study testing Hot saline irrigation and Room-temperature saline irrigation in people with Rhinosinusitis Chronic and Bleeding, run by Military Institute of Aviation Medicine at 1 site in Poland.
Trial summary
Objectives: Intraoperative bleeding during endoscopic sinus surgery for severe rhinosinusitis may significantly compromise the surgical field. Saline heated to 50°C promotes transient vessel vasodilation and mucosal edema without causing nasal mucosal necrosis. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Rhinosinusitis Chronic, Bleeding
- What is being tested?
- Hot saline irrigation and Room-temperature saline irrigation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 sitePoland
- Study dates
- 1 Mar 2023to 28 May 2026
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Chronic rhinosinusitis diagnosed according to the EPOS 2020 criteria;
- Confirmed failure of conservative treatment, defined as persistence of CRS symptoms for more than 12 weeks despite optimal pharmacological therapy;
- Age over 18 years and ability to provide informed consent;
- Written informed consent to participate in the study;
- Presence of inflammatory changes on sinus computed tomography scans.
Who cannot join
- Lack of patient consent;
- Disease limited to a single sinus;
- Conditions associated with ciliary dyskinesia (e.g., cystic fibrosis);
- Suspected fungal infection or fungal ball;
- Poor adherence to medical recommendations or noncompliance with treatment;
- Suspected neoplastic disease;
- Suspected or confirmed autoimmune disorders, particularly granulomatosis with polyangiitis;
- - Confirmed or clinically suspected immunodeficiency; Diagnosed coagulation disorders or preoperative hemostasis test results outside laboratory reference ranges; Preoperative systemic glucocorticosteroid therapy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Hot Saline Irrigation on Intraoperative Bleeding and Improving Surgical Field Visibility During Functional Endoscopic Sinus Surgery: a Prospective Clinical Study.
Objectives: Intraoperative bleeding during endoscopic sinus surgery for severe rhinosinusitis may significantly compromise the surgical field. Saline heated to 50°C promotes transient vessel vasodilation and mucosal edema without causing nasal mucosal necrosis. The brief thermal exposure may induce superficial protein denaturation and facilitate local hemostasis, thereby improving endoscopic visibility. This study aims to assess the impact of 50°C saline irrigation on the overall intraoperative blood loss and surgical visualization during endoscopic sinus surgery for rhinosinusitis.
Methods: This prospective randomized controlled trial study is going to assign the patients to three groups. In the interventional hot saline group (HSI), intraoperative irrigation will be performed with heated saline at 50°C. In the room-temperature saline group (RTSI), saline at 22°C will be used; in the third one group (Control), no irrigation will be administered. Intraoperative blood loss will be recorded in milliliters and milliliters per minute of operative time, and the surgical field will be evaluated using the Boezaart scale.
HSI is hypothesized to be more effective than RTSI in minimizing intraoperative bleeding during FESS.
Read the detailed description
Introduction Chronic rhinosinusitis (CRS) affects approximately 5-15% of the European population and significantly reduces quality of life. While pharmacological treatment, including intranasal corticosteroids, nasal irrigation, and antibiotics, may be effective in many cases, some patients will require functional endoscopic sinus surgery (FESS). Compared with traditional surgery, FESS will provide better visualization, reduced tissue trauma, fewer complications, and shorter hospitalization. However, intraoperative bleeding will remain a major challenge, as even minor bleeding may impair endoscopic visibility and increase the risk of complications. Various methods, including controlled hypotension, vasoconstrictors, corticosteroids, and reverse Trendelenburg positioning, will be used to reduce bleeding. Heated saline irrigation may also represent a useful supportive technique.
Aim This prospective study will evaluate the effect of intraoperative hot saline irrigation (HSI) on blood loss and surgical field visibility during FESS compared with room-temperature saline irrigation (RTSI) and no irrigation.
Materials and Methods Adult patients with CRS meeting EPOS 2020 criteria and requiring FESS after unsuccessful conservative treatment will be included in this randomized, patient-blinded study. Patients with fungal disease, immunodeficiency, coagulation disorders, neoplastic or autoimmune disease, or preoperative systemic steroid use will be excluded.
Participants will be randomized into three groups: HSI (0.9% NaCl at 50°C), RTSI (0.9% NaCl at 22°C), and control (no irrigation) using coin-toss allocation. Randomization will be conducted by an independent researcher not involved in surgery or postoperative assessment. Separation of responsibilities and independent surgical scheduling will be applied to reduce the risk of selection bias.
Surgical Procedure Surgical procedures will include middle meatal antrostomy, anterior and posterior ethmoidectomy, Draf I-IIa procedure, and bilateral sphenoidectomy performed without preoperative topical decongestants. A 2.7-mm Hopkins nasal endoscope (0°, 30°, 45°, or 70°; Karl Storz) and a microdebrider will be used during all procedures.
Anesthesia General anesthesia will be administered according to a standardized protocol. Anesthesia induction will be achieved with propofol, analgesia with fentanyl or remifentanil, maintenance with sevoflurane or desflurane, neuromuscular blockade with rocuronium bromide, and reversal with atropine plus neostigmine or sugammadex, depending on individual patient requirements.
Study Procedure Nasal irrigation will be performed using 0.9% NaCl at either 22°C or 50°C at least three times during surgery at 10-minute intervals. The 50°C saline solution will be stored in a laboratory incubator, while the 22°C solution will be maintained at room temperature. Irrigation will be delivered through a metal cannula connected to a syringe and inserted into the middle nasal meatus over approximately 5 seconds.
Following each irrigation, the surgical field will be evaluated using the 6-point Boezaart scale after suctioning the irrigation fluid mixed with blood from the nasopharynx. In the control group, surgical field visibility will be assessed every 10 minutes. Total blood loss will be calculated as the difference between the irrigation volume and the total suctioned fluid volume, and mean blood loss per minute will also be recorded.
The primary outcome measure will be total intraoperative blood loss. Secondary outcomes will include blood loss per minute of operative time and surgical field quality assessed using the Boezaart scale.
Data collection and analysis:
This is a pilot study; hence the statistical analysis will be completed at the end of the study.
Each participant will receive a unique study identification number to ensure anonymity and prevent the collection of directly identifiable personal data. Study data will be recorded in a Microsoft Excel database and will include demographic characteristics, comorbidities, current pharmacological treatment, Lund-Mackay CT score, CRS phenotype with or without nasal polyps, type of surgery (primary or revision), anesthetic infusion details, mean arterial pressure and pulse rate measured at 15-minute intervals, endoscopic surgical field assessment scores recorded every 10 minutes, intraoperative complications, use of a microdebrider, total intraoperative blood loss, duration of surgery, and total volume of saline irrigation used.
- Conditions
- Rhinosinusitis Chronic, Bleeding
- Being tested
- Hot saline irrigation, Room-temperature saline irrigation
- Keywords
- bleeding, boezaart scale, saline irrigation, surgical endoscopic visibility, fess
- Medical subject headings
- Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hot saline irrigationProcedure or surgery
Intraoperative irrigation of the sinonasal cavity using 0.9% NaCl heated to 50°C during FESS.
Room-temperature saline irrigationProcedure or surgery
Also called 2
Intraoperative irrigation of the sinonasal cavity using 0.9% NaCl at 22°C during FESS.
| Study group | Role | What they receive |
|---|---|---|
| Hot Saline Irrigation | Experimental | Participants undergoing functional endoscopic sinus surgery (FESS) will receive intraoperative irrigation with 0.9% sodium chloride solution heated to 50°C at 10-minute intervals during surgery. Receives: Procedure: Hot saline irrigation |
| Room-Temperature Saline Irrigation | Experimental | Participants undergoing FESS will receive intraoperative irrigation with 0.9% sodium chloride solution at room temperature (22°C). Receives: Procedure: Room-temperature saline irrigation |
| Control Group | No intervention | Participants undergoing FESS without intraoperative saline irrigation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total intraoperative bleeding
The effect of intraoperative irrigation with hot 0.9% NaCl on total intraoperative blood loss during FESS, compared with room-temperature NaCl irrigation and no irrigation, that will be measured in mililiters (ml).
Measured: From the beginning until the end of the surgery
Secondary outcomes (2)
Surgical field visibility
The effect of intraoperative irrigation with hot 0.9% NaCl on surgical field visibility of operative time during FESS, compared with room-temperature NaCl irrigation and no irrigation. To measure this visibility - Boezaart score (from 0-5) will be used.
Measured: From the beginning of the operation until the end.
The effect of intraoperative irrigation with hot 0.9% NaCl surgical field visibility and blood loss per minute of operative time during FESS, compared with room-temperature NaCl irrigation and no irrigation.
The effect of intraoperative irrigation with hot 0.9% NaCl on blood loss per minute of operative time during FESS, compared with room-temperature NaCl irrigation and no irrigation. Unit of measure: ml/min.
Measured: From the beginning to the end of surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2026
- Study start1 Mar 2023
- Primary completion1 Dec 2025
- Study completion28 May 2026
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 Rhinosinusitis ChronicStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Military Institute of Aviation Medicine
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Agnieszka Witkowska-Janik, MD, PhD, Principal investigator, Military Institute of Aviation Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07627789
- Sponsor's protocol ID
- Bioethics Comm. MMC (232/22)
- Status last verified
- Jun 2026
- First submitted
- 27 May 2026
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data collected during the study will not be made publicly available.
Publications
Altaf J, Ashfaq AH, Riaz N, Arshad M, Ayub N, Rehman A, Maqbool S. Effect of hot saline irrigation on the operative field during endoscopic sinus surgery: a randomized controlled trial. Eur Arch Otorhinolaryngol. 2025 Jan;282(1):235-240. doi: 10.1007/s00405-024-09005-0. Epub 2024 Oct 1.
PubMed 39354187Stangerup SE, Thomsen HK. Histological changes in the nasal mucosa after hot-water irrigation. An animal experimental study. Rhinology. 1996 Mar;34(1):14-7.
PubMed 8739861Nagarajah D, Kueh YC, Lazim NM, Abdullah B. The hemostatic effect of hot saline irrigation in endoscopic sinus surgery: a systematic review and meta-analysis. Syst Rev. 2022 Nov 18;11(1):246. doi: 10.1186/s13643-022-02113-0.
PubMed 36401259Al-Qudah MA. The effect of intranasal irrigation with epinephrine solution on intraoperative visualization and bleeding during FESS. Eur Arch Otorhinolaryngol. 2022 Apr;279(4):1911-1917. doi: 10.1007/s00405-021-06952-w. Epub 2021 Jun 27.
PubMed 34175968
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hot Saline Irrigation on Intraoperative Bleeding and Improving Surgical Field Visibility During Functional Endoscopic Sinus Surgery: a Prospective Clinical Study.
- ClinicalTrials.gov ID
- NCT07627789
- Acronym / sponsor ID
- Bioethics Comm. MMC (232/22)
- Conditions
- Rhinosinusitis Chronic, Bleeding
- Keywords
- bleeding, boezaart scale, saline irrigation, surgical endoscopic visibility, fess
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Military Institute of Aviation MedicineOther government
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 1 Dec 2025 (actual)
- Study completion
- 28 May 2026 (actual)
- First posted
- 4 Jun 2026 (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.
Objectives: Intraoperative bleeding during endoscopic sinus surgery for severe rhinosinusitis may significantly compromise the surgical field. Saline heated to 50°C promotes transient vessel vasodilation and mucosal edema without causing nasal mucosal necrosis. The brief thermal exposure may induce superficial protein denaturation and facilitate local hemostasis, thereby improving endoscopic visibility. This study aims to assess the impact of 50°C saline irrigation on the overall intraoperative blood loss and surgical visualization during endoscopic sinus surgery for rhinosinusitis.
Methods: This prospective randomized controlled trial study is going to assign the patients to three groups. In the interventional hot saline group (HSI), intraoperative irrigation will be performed with heated saline at 50°C. In the room-temperature saline group (RTSI), saline at 22°C will be used; in the third one group (Control), no irrigation will be administered. Intraoperative blood loss will be recorded in milliliters and milliliters per minute of operative time, and the surgical field will be evaluated using the Boezaart scale.
HSI is hypothesized to be more effective than RTSI in minimizing intraoperative bleeding during FESS.
Detailed description
Introduction Chronic rhinosinusitis (CRS) affects approximately 5-15% of the European population and significantly reduces quality of life. While pharmacological treatment, including intranasal corticosteroids, nasal irrigation, and antibiotics, may be effective in many cases, some patients will require functional endoscopic sinus surgery (FESS). Compared with traditional surgery, FESS will provide better visualization, reduced tissue trauma, fewer complications, and shorter hospitalization. However, intraoperative bleeding will remain a major challenge, as even minor bleeding may impair endoscopic visibility and increase the risk of complications. Various methods, including controlled hypotension, vasoconstrictors, corticosteroids, and reverse Trendelenburg positioning, will be used to reduce bleeding. Heated saline irrigation may also represent a useful supportive technique.
Aim This prospective study will evaluate the effect of intraoperative hot saline irrigation (HSI) on blood loss and surgical field visibility during FESS compared with room-temperature saline irrigation (RTSI) and no irrigation.
Materials and Methods Adult patients with CRS meeting EPOS 2020 criteria and requiring FESS after unsuccessful conservative treatment will be included in this randomized, patient-blinded study. Patients with fungal disease, immunodeficiency, coagulation disorders, neoplastic or autoimmune disease, or preoperative systemic steroid use will be excluded.
Participants will be randomized into three groups: HSI (0.9% NaCl at 50°C), RTSI (0.9% NaCl at 22°C), and control (no irrigation) using coin-toss allocation. Randomization will be conducted by an independent researcher not involved in surgery or postoperative assessment. Separation of responsibilities and independent surgical scheduling will be applied to reduce the risk of selection bias.
Surgical Procedure Surgical procedures will include middle meatal antrostomy, anterior and posterior ethmoidectomy, Draf I-IIa procedure, and bilateral sphenoidectomy performed without preoperative topical decongestants. A 2.7-mm Hopkins nasal endoscope (0°, 30°, 45°, or 70°; Karl Storz) and a microdebrider will be used during all procedures.
Anesthesia General anesthesia will be administered according to a standardized protocol. Anesthesia induction will be achieved with propofol, analgesia with fentanyl or remifentanil, maintenance with sevoflurane or desflurane, neuromuscular blockade with rocuronium bromide, and reversal with atropine plus neostigmine or sugammadex, depending on individual patient requirements.
Study Procedure Nasal irrigation will be performed using 0.9% NaCl at either 22°C or 50°C at least three times during surgery at 10-minute intervals. The 50°C saline solution will be stored in a laboratory incubator, while the 22°C solution will be maintained at room temperature. Irrigation will be delivered through a metal cannula connected to a syringe and inserted into the middle nasal meatus over approximately 5 seconds.
Following each irrigation, the surgical field will be evaluated using the 6-point Boezaart scale after suctioning the irrigation fluid mixed with blood from the nasopharynx. In the control group, surgical field visibility will be assessed every 10 minutes. Total blood loss will be calculated as the difference between the irrigation volume and the total suctioned fluid volume, and mean blood loss per minute will also be recorded.
The primary outcome measure will be total intraoperative blood loss. Secondary outcomes will include blood loss per minute of operative time and surgical field quality assessed using the Boezaart scale.
Data collection and analysis:
This is a pilot study; hence the statistical analysis will be completed at the end of the study.
Each participant will receive a unique study identification number to ensure anonymity and prevent the collection of directly identifiable personal data. Study data will be recorded in a Microsoft Excel database and will include demographic characteristics, comorbidities, current pharmacological treatment, Lund-Mackay CT score, CRS phenotype with or without nasal polyps, type of surgery (primary or revision), anesthetic infusion details, mean arterial pressure and pulse rate measured at 15-minute intervals, endoscopic surgical field assessment scores recorded every 10 minutes, intraoperative complications, use of a microdebrider, total intraoperative blood loss, duration of surgery, and total volume of saline irrigation used.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Hot Saline Irrigation | Experimental | Procedure: Hot saline irrigationParticipants undergoing functional endoscopic sinus surgery (FESS) will receive intraoperative irrigation with 0.9% sodium chloride solution heated to 50°C at 10-minute intervals during surgery. |
| Room-Temperature Saline Irrigation | Experimental | Procedure: Room-temperature saline irrigationParticipants undergoing FESS will receive intraoperative irrigation with 0.9% sodium chloride solution at room temperature (22°C). |
| Control Group | No intervention | –Participants undergoing FESS without intraoperative saline irrigation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Chronic rhinosinusitis diagnosed according to the EPOS 2020 criteria;
- Confirmed failure of conservative treatment, defined as persistence of CRS symptoms for more than 12 weeks despite optimal pharmacological therapy;
- Age over 18 years and ability to provide informed consent;
- Written informed consent to participate in the study;
- Presence of inflammatory changes on sinus computed tomography scans.
Key exclusion criteria (8 listed)
- Lack of patient consent;
- Disease limited to a single sinus;
- Conditions associated with ciliary dyskinesia (e.g., cystic fibrosis);
- Suspected fungal infection or fungal ball;
- Poor adherence to medical recommendations or noncompliance with treatment;
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 |
|---|---|---|
| Hot saline irrigationIntraoperative irrigation of the sinonasal cavity using 0.9% NaCl heated to 50°C during FESS. | Procedure or surgery | Hot Saline Irrigation |
| Room-temperature saline irrigationAlso: 2Intraoperative irrigation of the sinonasal cavity using 0.9% NaCl at 22°C during FESS. | Procedure or surgery | Room-Temperature Saline Irrigation |
Primary outcome
Total intraoperative bleeding
Time frame: From the beginning until the end of the surgery
The effect of intraoperative irrigation with hot 0.9% NaCl on total intraoperative blood loss during FESS, compared with room-temperature NaCl irrigation and no irrigation, that will be measured in mililiters (ml).
2 secondary outcomes
Surgical field visibility
Time frame: From the beginning of the operation until the end.
The effect of intraoperative irrigation with hot 0.9% NaCl surgical field visibility and blood loss per minute of operative time during FESS, compared with room-temperature NaCl irrigation and no irrigation.
Time frame: From the beginning to the end of surgery.
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 4 Jun 2026.
- Background: PubMed 39354187Altaf J, Ashfaq AH, Riaz N, Arshad M, Ayub N, Rehman A, Maqbool S. Effect of hot saline irrigation on the operative field during endoscopic sinus surgery: a randomized controlled trial. Eur Arch Otorhinolaryngol. 2025 Jan;282(1):235-240. doi: 10.1007/s00405-024-09005-0. Epub 2024 Oct 1.
- Background: PubMed 8739861Stangerup SE, Thomsen HK. Histological changes in the nasal mucosa after hot-water irrigation. An animal experimental study. Rhinology. 1996 Mar;34(1):14-7.
- Background: PubMed 36401259Nagarajah D, Kueh YC, Lazim NM, Abdullah B. The hemostatic effect of hot saline irrigation in endoscopic sinus surgery: a systematic review and meta-analysis. Syst Rev. 2022 Nov 18;11(1):246. doi: 10.1186/s13643-022-02113-0.
- Background: PubMed 34175968Al-Qudah MA. The effect of intranasal irrigation with epinephrine solution on intraoperative visualization and bleeding during FESS. Eur Arch Otorhinolaryngol. 2022 Apr;279(4):1911-1917. doi: 10.1007/s00405-021-06952-w. Epub 2021 Jun 27.
- Individual participant dataSharing planned: No. Individual participant data collected during the study will not be made publicly available.
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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.
Agnieszka Witkowska-Janik, MD, PhD principal investigator
Military Institute of Aviation Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hot saline irrigation and Room-temperature saline irrigation in people with Rhinosinusitis Chronic and Bleeding, run by Military Institute of Aviation Medicine at 1 site in Poland.
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 5 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 4 Jun 2026. 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 Poland. 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?
Total intraoperative bleeding (time frame: From the beginning until the end of the surgery). 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 NCT07627789, 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 4 Jun 2026.