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Effects of Oxygen Cage Support During Cataract Surgery

23 czerwca 2026 zaktualizowane przez: 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.

Przegląd badań

Status

Jeszcze nie rekrutacja

Warunki

Interwencja / Leczenie

Szczegółowy opis

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 studiów

Interwencyjne

Zapisy (Szacowany)

70

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Opis

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

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie podtrzymujące
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Pojedynczy

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: 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.
Inny: 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
Brak interwencji: 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 mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Changes in End-Tidal Carbon Dioxide
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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).
Changes in Systolic and Diastolic Blood Pressure
Ramy czasowe: Baseline (15 minutes pre-operation), intraoperatively (at 5th, 10th, 15th, 20th, 25th minute), and postoperatively (5 minutes 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 minutes pre-operation), intraoperatively (at 5th, 10th, 15th, 20th, 25th minute), and postoperatively (5 minutes after transfer to room)
Changes in Respiratory Rate
Ramy czasowe: Baseline (15 minutes pre-operation), intraoperatively (at 5th, 10th, 15th, 20th, 25th minute), and postoperatively (5 minutes 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 minutes pre-operation), intraoperatively (at 5th, 10th, 15th, 20th, 25th minute), and postoperatively (5 minutes after transfer to room).
Changes in Heart Rate
Ramy czasowe: Baseline (15 minutes pre-operation), intraoperatively (at 5th, 10th, 15th, 20th, 25th minute), and postoperatively (5 minutes 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 minutes pre-operation), intraoperatively (at 5th, 10th, 15th, 20th, 25th minute), and postoperatively (5 minutes after transfer to room)
Changes in Oxygen Saturation
Ramy czasowe: Baseline (15 minutes pre-operation), intraoperatively (at 5th, 10th, 15th, 20th, 25th minute), and postoperatively (5 minutes 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 minutes pre-operation), intraoperatively (at 5th, 10th, 15th, 20th, 25th minute), and postoperatively (5 minutes after transfer to room)

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Ataturk University

Publikacje i pomocne linki

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Publikacje ogólne

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

1 lipca 2026

Zakończenie podstawowe (Szacowany)

1 maja 2027

Ukończenie studiów (Szacowany)

1 maja 2027

Daty rejestracji na studia

Pierwszy przesłany

20 maja 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

2 czerwca 2026

Pierwszy wysłany (Rzeczywisty)

8 czerwca 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

26 czerwca 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

23 czerwca 2026

Ostatnia weryfikacja

1 czerwca 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • ZKP_ATAUNI_001
  • Ataturk Unıversity (Inny identyfikator: Ataturk Unıversity)

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

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