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Effects of Oxygen Cage Support During Cataract Surgery

2026年6月23日 更新者：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.

調査の概要

状態

まだ募集していません

条件

介入・治療

詳細な説明

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.

研究の種類

介入

入学 (推定)

70

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：支持療法
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：独身

武器と介入

参加者グループ / アーム
介入・治療
実験的：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.
他の：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
介入なし：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.

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Changes in End-Tidal Carbon Dioxide
時間枠：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)
時間枠：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)
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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)

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Ataturk University

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年7月1日

一次修了 (推定)

2027年5月1日

研究の完了 (推定)

2027年5月1日

試験登録日

最初に提出

2026年5月20日

QC基準を満たした最初の提出物

2026年6月2日

最初の投稿 (実際)

2026年6月8日

学習記録の更新

投稿された最後の更新 (実際)

2026年6月26日

QC基準を満たした最後の更新が送信されました

2026年6月23日

最終確認日

2026年6月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • ZKP_ATAUNI_001
  • Ataturk Unıversity (その他の識別子：Ataturk Unıversity)

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

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米国FDA規制医薬品の研究

いいえ

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いいえ

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