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Effects of Oxygen Cage Support During Cataract Surgery

2. června 2026 aktualizováno: Zeynep Kaya Pehlivan, Ataturk University

The Effect of Oxygen Support Cage Material Use During Cataract Surgery on Operation Time, Anxiety, Physiological Parameters, and Patient Experiences: A Mixed Methods Study

Cataract is an ocular disorder resulting from lens opacity; it stands as the most common cause of preventable blindness worldwide and significantly impairs the quality of life in elderly individuals. Surgical treatment utilizing small-incision phacoemulsification is the most effective solution for cataracts. Cataract surgery is generally performed under local anesthesia, which requires patients to remain awake throughout the operation, thereby potentially increasing their anxiety experiences. Elevated anxiety not only reduces patient comfort but can also lead to alterations in physiological parameters and a prolongation of the operation time. Furthermore, it is observed that the surgical drapes used to maintain the sterility of the surgical field during the operation cause discomfort to the patient. The weight and positioning of these drapes can cover the patient's mouth and nose area during the ongoing surgery, creating a sensation of difficulty in breathing (dyspnea). In addition to these circumstances, standard oxygen support is provided to the patient during cataract surgery performed under local anesthesia. This support is administered nasally via an open-ended oxygen tubing from beneath the surgical drape, aiming to ease the patient's respiration. However, when the oxygen flow rate is increased based on the patient's needs, high-velocity and high-concentration oxygen administration is observed to cause mucosal dryness, which shortly triggers reflex-induced irritative coughing attacks. For these reasons, it is crucial to keep anxiety under control, provide oxygen to prevent hypoxia, and monitor physiological parameters during cataract surgery.

Přehled studie

Postavení

Zatím nenabíráme

Podmínky

Intervence / Léčba

Detailní popis

This study is designed as a mixed-methods research project comprising two distinct but interconnected phases. The quantitative phase utilizes a randomized controlled experimental design to evaluate the physiological and clinical efficacy of a newly developed Oxygen Support Cage material. The qualitative phase employs a descriptive phenomenological approach to explore patients' in-depth subjective experiences, comfort levels, and perceptions regarding the device.

Patients assigned to the intervention group will undergo cataract surgery with the integration of the 3D-printed, biocompatible Oxygen Support Cage. This device is positioned over the patient's head area to elevate the sterile surgical drapes, effectively preventing direct contact and weight pressure on the patient's face, mouth, and nose. Concurrently, supplemental oxygen will be delivered into the cage micro-environment. This setup aims to maintain an optimal, stable oxygen concentration without high-velocity nasal flow, thereby mitigating mucosal dryness and potential cough reflexes. Patients assigned to the control group will receive the standard hospital protocol for cataract surgery, where supplemental oxygen is administered nasally via open-ended oxygen tubing beneath standard surgical drapes without any cage support.

Physiological parameters (including blood pressure, heart rate, respiratory rate, oxygen saturation, and end-tidal carbon dioxide [EtCO2]) will be monitored and recorded chronologically at predefined intervals: 15 minutes before descending to the operating room (in the patient room), during specific intraoperative stages, and postoperatively in the recovery room. Anxiety levels and surgical durations will be documented accordingly.

Following the completion of the surgical procedures and quantitative data collection, a subset of participants from the intervention group will be invited to participate in semi-structured, face-to-face qualitative interviews. These interviews will focus on their sensory experiences, breathing comfort, confinement anxiety under the drapes, and overall satisfaction with the Oxygen Support Cage. By combining statistical findings with thematic analysis of patient narratives, the study aims to provide a holistic validation of the medical device's utility in clinical practice.

Typ studie

Intervenční

Zápis (Odhadovaný)

70

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ne

Popis

Inclusion Criteria

  • Willing to participate in the study voluntarily and provides informed consent
  • Aged 18 years or older
  • Having no hearing or cognitive impairments
  • Undergoing cataract surgery for the first time Exclusion Criteria
  • Conversion from local anesthesia to general anesthesia during the surgery
  • Patient's non-participation or refusal to complete the anxiety assessment during the surgery

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Podpůrná péče
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Singl

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: Oxygen Support Cage Group
Participants in this arm will undergo cataract surgery with the integration of a newly developed, 3D-printed, biocompatible Oxygen Support Cage. This medical device is placed over the patient's head to elevate the sterile surgical drapes, preventing them from exerting weight pressure or making direct contact with the patient's face, mouth, and nose. Supplemental oxygen is delivered directly into the cage micro-environment to ensure stable, high-concentration oxygenation. This setup aims to prevent mucosal dryness and irritative cough reflexes while reducing drape-induced anxiety and dyspnea.
Jiný: Oxygen Support Cage

This intervention utilizes a uniquely structured, 3D-printed, and biocompatible Oxygen Support Cage designed specifically for patients undergoing cataract surgery under local anesthesia. Unlike standard clinical procedures where surgical drapes lay directly on the patient's face and supplemental oxygen is administered via high-velocity nasal tubing, this device acts as a physical barrier. It is positioned over the patient's head to lift the weight of the sterile drapes completely off the mouth and nose area, thereby eliminating drape-induced physical pressure, a sense of confinement, and dyspnea.

Concurrently, the device features a specialized design that allows supplemental oxygen to be delivered directly into the cage micro-environment. This setup eliminates the need for direct nasal cannulas, preventing high-velocity airflow from causing mucosal dryness and subsequent iritative cough reflexes during crucial microscopic surgical steps. This dual-action approach simultaneously addres
Žádný zásah: Control Group: Standard Care
Participants in this arm will receive the standard hospital protocol for cataract surgery under local anesthesia. Supplemental oxygen will be administered nasally via standard open-ended oxygen tubing placed directly beneath the conventional surgical drapes. No cage support or drape-elevating device will be used; the sterile surgical drapes will rest directly over the patient's face as per routine clinical practice.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Changes in Systolic and Diastolic Blood Pressure
Časové okno: Baseline (15 min pre-operation), intraoperatively (at 5th, 10th, 15th, 20th, 25th min), and postoperatively (5 min after transfer to room).
Evaluates perioperative and intraoperative hemodynamic stability. Measurements are performed using the cardiac monitoring unit of the anesthesia machine during surgery, and a portable monitor postoperatively.
Baseline (15 min pre-operation), intraoperatively (at 5th, 10th, 15th, 20th, 25th min), and postoperatively (5 min after transfer to room).
Changes in Respiratory Rate
Časové okno: Baseline (15 min pre-operation), intraoperatively (at 5th, 10th, 15th, 20th, 25th min), and postoperatively (5 min after transfer to room).
Evaluates perioperative and intraoperative respiratory stability. Measurements are performed using the gas module/monitoring of the anesthesia machine during surgery, and a portable monitor postoperatively.
Baseline (15 min pre-operation), intraoperatively (at 5th, 10th, 15th, 20th, 25th min), and postoperatively (5 min after transfer to room).
Changes in Heart Rate
Časové okno: Baseline (15 min pre-operation), intraoperatively (at 5th, 10th, 15th, 20th, 25th min), and postoperatively (5 min after transfer to room).
Evaluates perioperative and intraoperative cardiac stability. Measurements are performed using the cardiac monitoring unit of the anesthesia machine during surgery, and a portable monitor postoperatively.
Baseline (15 min pre-operation), intraoperatively (at 5th, 10th, 15th, 20th, 25th min), and postoperatively (5 min after transfer to room).
Changes in Oxygen Saturation
Časové okno: Baseline (15 min pre-operation), intraoperatively (at 5th, 10th, 15th, 20th, 25th min), and postoperatively (5 min after transfer to room).
Evaluates perioperative and intraoperative peripheral oxygenation levels. Measurements are performed using the pulse oximetry unit of the anesthesia machine during surgery, and a portable monitor postoperatively.
Baseline (15 min pre-operation), intraoperatively (at 5th, 10th, 15th, 20th, 25th min), and postoperatively (5 min after transfer to room).
Changes in End-Tidal Carbon Dioxide
Časové okno: Intraoperatively (at the 5th, 10th, 15th, 20th, and 25th minutes of the surgery).
Evaluates intraoperative ventilation status. Measurements are performed using the gas module of the GE Datex Ohmeda S Avance anesthesia machine. (Note: This parameter is only measured intraoperatively)
Intraoperatively (at the 5th, 10th, 15th, 20th, and 25th minutes of the surgery).
Changes in Anxiety Level Evaluated by State-Trait Anxiety Inventory (STAI-S)
Časové okno: Baseline (15 minutes pre-operation) and postoperatively (5 minutes after transfer back to the patient room)
Evaluates the patient's pre-operative and post-operative situational anxiety levels using the State-Trait Anxiety Inventory (STAI-S). The scale score ranges from 20 to 80, where higher scores indicate higher levels of anxiety.
Baseline (15 minutes pre-operation) and postoperatively (5 minutes after transfer back to the patient room)
Changes in Anxiety Level Evaluated by Visual Analog Scale for Anxiety (VAS-A)
Časové okno: Baseline (15 minutes pre-operation), intraoperatively (at the 15th minute of the surgery), and postoperatively (5 minutes after transfer back to the patient room).

Evaluates the patient's anxiety levels across perioperative, intraoperative, and postoperative phases using the Visual Analog Scale for Anxiety (VAS-A). The scale ranges from 0 to 10, where 0 indicates no anxiety and 10 indicates the worst possible anxiety.

Preoperative: Baseline measurement in the patient room.

Intraoperative: Real-time anxiety assessment under the surgical drapes at the 15th minute of cataract surgery without disrupting the sterile field.

Postoperative: Assessment in the patient room after transfer.
Baseline (15 minutes pre-operation), intraoperatively (at the 15th minute of the surgery), and postoperatively (5 minutes after transfer back to the patient room).

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Ataturk University

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

1. července 2026

Primární dokončení (Odhadovaný)

1. května 2027

Dokončení studie (Odhadovaný)

1. května 2027

Termíny zápisu do studia

První předloženo

20. května 2026

První předloženo, které splnilo kritéria kontroly kvality

2. června 2026

První zveřejněno (Aktuální)

8. června 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

8. června 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

2. června 2026

Naposledy ověřeno

1. června 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • ZKP_ATAUNI_001
  • Ataturk Unıversity (Jiný identifikátor: Ataturk Unıversity)

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

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