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临床试验/CTRI/2025/03/083514
CTRI/2025/03/083514尚未招募不适用

Evaluation of efficacy in detection of apnoea and airway suctioning using a novel capnosuction mask in adults scheduled for elective surgeries under sedation - An observational feasible study

Saveetha medical college and hospital1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2025年5月20日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
50
试验地点
1
主要终点
Early detection of apnoea - breathing cessation for more than 15 secs

研究概览

简要总结

Patients were assessed in the sitting position for airway parameters before being positioned supine. Vital signs, including blood pressure (BP), oxygen saturation (SaOâ‚‚), and heart rate, were recorded prior to sedation. All patients undergoing sedation were connected to a CAPNOSUCTION mask before administering sedatives.

Sedation Protocol:

An initial intravenous dose of 1 mg midazolam ,loading dose of dexmedetomidine 0.5-1mcg/kg over 20mins was followed by 1% propofol adjusted to body weight, age, and comorbidities (40 mg for <70 kg, 60 mg for ≥70 kg, or 20 mg for elderly or comorbid patients). Additional 10–20 mg doses of propofol were administered as needed.

Monitoring:

Patients were continuously monitored for respiratory and cardiovascular parameters. Heart rate, pulse oximetry, and ECG changes were assessed, while BP was checked every 5 minutes. Capnography provided real-time assessments of ventilatory function via CO₂ waveforms and partial pressure (mmHg). Apnea was defined as exhaled CO₂ <8 mmHg for ≥15 seconds. Interventions for apnea or complications like oxygen desaturation (SaO₂ ≥5% below baseline), hypoxemia (SaO₂ <90%), hypotension (systolic BP <90 mmHg), or bradycardia (<50 bpm) included patient stimulation, withholding sedatives, airway maneuvers, or increased oxygen. Secretions were cleared through the mask’s secretion port.

After the procedure, monitoring was discontinued once patients responded verbally and vital signs stabilized. They were then transferred to recovery.

研究设计

研究类型
Observational

入排标准

年龄范围
20.00 Year(s) 至 50.00 Year(s)(—)
性别
All

入选标准

  • 1.Patient undergoing elective surgeries under sedation (TIVA) 2.ASA I / 2.

排除标准

  • 1.ASA3/4/5 2.allergy to narcotic and recent drug allergy 3.difficult airway.

结局指标

主要结局

Early detection of apnoea - breathing cessation for more than 15 secs

时间窗: Clinically detected apnea, oxygen desaturation and hypoxemia prompted an intervention that consisted of patient stimulation, withholding medication, a chin lift or jaw thrust maneuver, or increasing oxygen supplementation .

次要结局

  • Airway suctioning when required(Patient secretions were cleared through the secretion port to maintain airway patency.)

研究者

发起方
Saveetha medical college and hospital
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Shanthi S

Saveetha medical college and hospital

研究点 (1)

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