Acute Ocular Hypertension Glaucoma, Intraocular Hypertension, Primary Angle-Closure Glaucoma
Conditions
Keywords
Mannitol Infusion Warming, Intravenous Infusion, Infusion Pain, Intraocular Pressure, Ocular Hypertension, Ophthalmic Nursing
Brief summary
Acute ocular hypertension is a common ophthalmic emergency that often requires rapid reduction of intraocular pressure. Intravenous mannitol is widely used for this purpose, but infusion-related pain and local venous irritation may reduce patient comfort, interfere with infusion speed, and affect treatment experience. This randomized controlled study aims to evaluate whether use of an infusion warming device during intravenous mannitol administration can reduce infusion-related pain, improve patient comfort, decrease local infusion-related complications, and improve infusion efficiency and short-term intraocular pressure outcomes in patients with acute ocular hypertension. Participants with acute ocular hypertension who required intravenous mannitol treatment were randomly assigned to either a warming group or a non-warming group. In the warming group, mannitol was administered using an infusion warming device; in the non-warming group, mannitol was administered according to routine practice without warming. Outcomes included peak pain score during infusion, comfort score, infusion rate, infusion duration, local infusion-related adverse reactions, and intraocular pressure change after treatment.
Detailed description
Acute ocular hypertension requires timely reduction of intraocular pressure to relieve symptoms and reduce the risk of optic nerve damage. Intravenous mannitol is commonly used in ophthalmic emergency care because of its rapid osmotic effect. However, mannitol infusion may cause infusion-related pain, discomfort, slowing or interruption of infusion, and local venous complications such as irritation and phlebitis. These problems may affect both patient experience and treatment efficiency. Warming of intravenous fluids has been used in clinical practice to reduce discomfort associated with infusion of hyperosmotic or irritating solutions. In this study, an infusion warming device was applied during intravenous mannitol administration to examine whether warming could improve the tolerability and clinical performance of mannitol infusion in patients with acute ocular hypertension. Eligible patients requiring intravenous mannitol treatment were assigned to either a warming group or a non-warming group. In the warming group, mannitol was administered through an infusion warming device according to the study protocol. In the non-warming group, mannitol was infused without warming according to routine clinical practice. Patient-reported outcomes and clinical outcomes were assessed during and shortly after infusion. The main objective of the study was to compare infusion-related pain between the two groups. Additional objectives were to compare comfort, infusion efficiency, local infusion-related complications, and short-term intraocular pressure response after treatment. The study was conducted at a tertiary ophthalmic center in China.
Interventions
DEVICEInfusion Warming Device
An infusion warming device was used during intravenous mannitol administration to warm the infused fluid according to the study protocol.
OTHERRoutine Non-Warmed Mannitol Infusion
Intravenous mannitol was administered according to routine clinical practice without infusion warming.
Sponsors
Joint Shantou International Eye Center of Shantou University and the Chinese University of Hong Kong
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
This was an open-label study because the use of an infusion warming device could not be concealed from participants or care providers during treatment delivery.
Intervention model description
Participants were randomly assigned in a parallel manner to receive intravenous mannitol infusion either with an infusion warming device or without warming. Each participant was assigned to one study arm only.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with acute ocular hypertension requiring intravenous mannitol treatment in the ophthalmology setting * Age 18 years or older * Conscious and able to communicate pain and comfort during infusion * Able to provide informed consent personally or via a legally authorized representative when appropriate * Able to complete study-related assessments during and shortly after mannitol infusion
Exclusion criteria
* Patients who did not require intravenous mannitol treatment * Known contraindication to intravenous mannitol treatment according to routine clinical practice * Patients receiving infusion of heat-sensitive fluids or medications for which infusion warming was not appropriate * Severe cognitive impairment, communication difficulty, or other conditions preventing reliable assessment of pain or comfort * Failure to complete key study outcome assessments * Refusal to participate in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Peak pain score during infusion measured by the 11-point Numeric Rating Scale (NRS) | During infusion, up to approximately 45 minutes | Peak infusion-related pain during intravenous mannitol administration, assessed using the 11-point Numeric Rating Scale (NRS). Scores range from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate worse pain. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Comfort during infusion measured by a 10-point Visual Analogue Scale (VAS) | During infusion, up to approximately 45 minutes | Patient-reported comfort during intravenous mannitol administration, assessed using a 10-point Visual Analogue Scale (VAS). Scores range from 0 to 10, where 0 indicates the lowest comfort and 10 indicates the highest comfort. Higher scores indicate better comfort. |
| Maximum infusion rate (drops/minute) | During infusion, up to approximately 45 minutes | Maximum achievable intravenous infusion rate during mannitol administration, recorded in drops per minute. Higher values indicate faster infusion delivery. |
| Total infusion duration (minutes) | From infusion start to completion of the full 250 mL infusion, up to approximately 45 minutes | Total duration of intravenous mannitol infusion, measured in minutes from the start to the completion of the full 250 mL infusion. Lower values indicate shorter infusion duration. |
| Intraocular pressure measured by iCare rebound tonometry at 30 minutes after infusion | 30 minutes after completion of the full 250 mL infusion | Intraocular pressure measured using an iCare rebound tonometer. Results are reported in mmHg. Lower values indicate lower intraocular pressure. |
| Change in intraocular pressure measured by iCare rebound tonometry | From pre-infusion baseline to 30 minutes after completion of the full 250 mL infusion | Change in intraocular pressure from pre-infusion measurement to the measurement obtained 30 minutes after completion of the full 250 mL infusion, assessed using an iCare rebound tonometer and reported in mmHg. Higher positive values indicate greater reduction in intraocular pressure. |
| Request for slowing or temporary interruption of infusion due to infusion-related discomfort/pain | During infusion, up to approximately 45 minutes | Whether the participant requested slowing or temporary interruption of the infusion because of infusion-related discomfort or pain. Reported as yes/no. |
| Pain affecting mood or rest | During infusion, up to approximately 45 minutes | Whether infusion-related pain affected participant mood or rest during treatment. Reported as yes/no. |
| Grade I phlebitis assessed by clinical observation | During infusion and immediately after completion of infusion, up to approximately 1 hour | Occurrence of infusion-related phlebitis assessed clinically by the nursing team according to local routine practice. Reported as yes/no. |
| Local redness, swelling, or induration assessed by clinical observation | During infusion and immediately after completion of infusion, up to approximately 1 hour | Occurrence of local infusion-site redness, swelling, or induration assessed clinically by the nursing team. Reported as yes/no. |
Countries
China
Contacts
PRINCIPAL_INVESTIGATORLaiwen Lv, Master
Joint Shantou International Eye Center of Shantou University and the Chinese University of Hong Kong
Outcome results
None listed