Effects of Oxygen Cage Support During Cataract Surgery

ConditionCataract
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-90
SponsorAtaturk University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Conversion from local anesthesia to general anesthesia during the surgery

Patient's non-participation or refusal to complete the anxiety assessment during the surgery

Trial design

Design model

Parallel

Treatments tested in this trial

  • Oxygen Support Cage

    Other intervention

    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

Treatment groups

70 Participants
are divided into 2 treatment groups
Group A: Oxygen Support Cage GroupExperimental treatment 1 intervention
Group B: Control Group: Standard CareNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Changes in Systolic and Diastolic Blood Pressure

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.

Time frame
Baseline (15 minutes pre-operation), intraoperatively (at 5th, 10th, 15th, 20th, 25th minute), and postoperatively (5 minutes after transfer to room)
2

Changes in Respiratory Rate

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.

Time frame
Baseline (15 minutes pre-operation), intraoperatively (at 5th, 10th, 15th, 20th, 25th minute), and postoperatively (5 minutes after transfer to room).
3

Changes in Heart Rate

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.

Time frame
Baseline (15 minutes pre-operation), intraoperatively (at 5th, 10th, 15th, 20th, 25th minute), and postoperatively (5 minutes after transfer to room)
4

Changes in Oxygen Saturation

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.

Time frame
Baseline (15 minutes pre-operation), intraoperatively (at 5th, 10th, 15th, 20th, 25th minute), and postoperatively (5 minutes after transfer to room)

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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