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Evaluation of the application effect and safety of open ventilation masks in ophthalmic surgery during PDR: A randomized controlled study

Evaluation of the application effect and safety of open ventilation masks in ophthalmic surgery during PDR: A randomized controlled study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400084286
Enrollment
Unknown
Registered
2024-05-14
Start date
2024-05-14
Completion date
Unknown
Last updated
2024-05-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes retinopathy

Interventions

control group:Using nasal cannula for oxygen inhalation
experimental group:Using an open ventilation mask for oxygen inhalation in ophthalmic surgery

Sponsors

Xuzhou First People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1)Select patients with type 2 diabetes who are between 18 and 80 years old and meet the diagnostic criteria established by the Endocrinology Branch of the Chinese Medical Association through clinical examination. The eye diagnostic criteria meet the PDR diagnostic criteria in the 2014 China diabetes Retinopathy Clinical Diagnosis and Treatment Guidelines; (2)The affected eye has vitreous hemorrhage, and the accumulation of blood cannot be absorbed within 1-3 months of occurrence; Organization of the affected eye Membranes or presence of tension bands can cause macular edema in the affected eye; The patient has vitreous hemorrhage and also experiences traction Sexual retinal detachment; There is a neovascular membrane present in the retina or macula. (3)All patients need to receive PPV treatment (4)Patients are informed and voluntarily sign informed consent forms

Exclusion criteria

Exclusion criteria: (1) Severe cardiac insufficiency, with cardiovascular and cerebrovascular accidents occurring within the past 6 months; (2) Severe liver and kidney dysfunction; (3) Individuals with abnormal coagulation function; (4) The presence of other retinal and choroidal diseases or other eye diseases (glaucoma, high myopia, etc.) in the affected eye can affect the surgical results; (5) History of vitreoretinal surgery in the surgical eye;

Design outcomes

Primary

MeasureTime frame
blood pressure;Blood oxygen saturation;heart rate;Respiratory rate;Patient comfort level;Surgical success rate;

Secondary

MeasureTime frame
Surgical time;Intraoperative complications;

Countries

china

Contacts

Public ContactLi Suyan

Xuzhou First People's Hospital

lisuyan1226@126.com+86 138 5210 1775

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026