Effects of Oxygen Cage Support During Cataract Surgery

Official title

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

Overview

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.

Detailed description

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.

Interventions

• Other 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 a

Primary outcome measures

• Changes in Systolic and Diastolic Blood Pressure [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: Baseline (15 minutes pre-operation), intraoperatively (at 5th, 10th, 15th, 20th, 25th minute), and postoperatively (5 minutes after transfer to room)]
• Changes in End-Tidal Carbon Dioxide [Time frame: 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) [Time frame: 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) [Time frame: Baseline (15 minutes pre-operation), intraoperatively (at the 15th minute of the surgery), and postoperatively (5 minutes after transfer back to the patient room).]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Supportive care

Study locations

Center list to be confirmed — check the primary protocol.

Publications

• Guan GQ, Lin XD, Bao JL, Zhou XZ. Effect of cervical pillow in phacoemulsification surgery for age-related cataract patients: a prospective randomized controlled study. Int Ophthalmol. 2024 Jun 11;44(1):232. doi: 10.1007/s10792-024-03090-0. PMID 38861013
• Yenigun SC, Demir Korkmaz F. The Effects of Stress Ball Practice on Patient Anxiety, Pain and Vital Signs During Cataract Surgery: A Randomized Controlled Trial. Pain Manag Nurs. 2025 Oct;26(5):592-599. doi: 10.1016/j.pmn.2025.04.009. Epub 2025 May 20. PMID 40399154

Identifiers

NCT: NCT07632326 · ZKP_ATAUNI_001 · Ataturk Unıversity

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗