Effects of Non-Traumatic Nasopharyngeal Suction Technique in Infants During Non-Invasive Ventilation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Change in Pain Score During Suctioning, N-PASS (Neonatal Pain, Agitation, and Sedation Scale) pain subscore
研究概览
简要总结
Background: Non-invasive ventilation (NIV) in preterm infants often leads to secretion-related airway obstructions, requiring suctioning. Traditional oro/nasopharyngeal suction techniques may cause mucosal trauma, pain, and physiological instability.
Objective: To evaluate the effects of a novel non-traumatic oro/nasopharyngeal suction technique on physiological and behavioral parameters in preterm infants receiving NIV.
Methods: A randomized controlled trial was conducted with 100 preterm infants (32 0/6 - 36 6/7 weeks gestation) admitted to a Level IV NICU. Infants were randomized into intervention (non-traumatic suction) and control (routine suction) groups. Data on heart rate, respiratory rate, SpO₂, skin color, and pain/sedation scores (N-PASS) were collected before, during, and after suctioning.
详细描述
This randomized controlled clinical trial was conducted to evaluate the effectiveness of a newly developed non-traumatic oro/nasopharyngeal suction technique in preterm infants receiving non-invasive ventilation (NIV). Traditional suction methods used to remove airway secretions in neonates are often associated with complications such as mucosal trauma, bradycardia, hypoxia, and increased pain.
The non-traumatic technique involves administering a small volume of sterile saline through one nostril and using gentle suction from the other nostril or the mouth without direct mucosal contact. This approach is designed to minimize trauma and discomfort.
A total of 100 preterm infants with gestational ages between 32 0/6 and 36 6/7 weeks were included and randomized into two groups: an intervention group receiving the non-traumatic suction method and a control group undergoing standard suction. Key outcome measures included physiological parameters (heart rate, respiratory rate, SpO₂, skin color) and behavioral indicators assessed using the Neonatal Pain, Agitation, and Sedation Scale (N-PASS). Data were collected before, during, and after suctioning procedures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- Single (Investigator)
盲法说明
Single (Investigator)
入排标准
- 年龄范围
- 32 Weeks 至 37 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Gestational age between 32 0/6 and 36 6/7 weeks
- •Receiving non-invasive ventilation (NIV) via nasal CPAP
- •Clinically stable prior to suctioning
- •Parental or legal guardian informed consent obtained
- •Age within first 7 days of life at time of first suction procedure
排除标准
- •Major congenital anomalies (e.g., craniofacial malformations, cardiac defects)
- •Suspected or confirmed neurological disorders (e.g., intraventricular hemorrhage Grade III/IV)
- •Presence of upper airway obstruction or nasal anomalies
- •Infants requiring invasive mechanical ventilation at the time of study
- •Any condition requiring continuous sedation or analgesia
- •Hemodynamically unstable infants (e.g., hypotension requiring inotropes)
- •Parental refusal or withdrawal of consent
研究组 & 干预措施
Non-Traumatic Suction Group
Infants in this group underwent a non-traumatic oro/nasopharyngeal suction procedure. A 10 Fr suction catheter with a blunt-cut tip and a 10 ml syringe were used. Depending on secretion amount and thickness, 5-10 ml of 0.9% saline was rapidly instilled through one nostril. Secretions were then aspirated using 150-200 mmHg negative pressure via the opposite nostril and the mouth, without deep catheter insertion.
Physiological parameters (heart rate, respiratory rate, oxygen saturation, skin color) and behavioral responses (N-PASS pain and sedation scores) were recorded before, during, and 10 minutes after the procedure.opposite nostril and the mouth, without deep catheter insertion. The procedure was carefully performed without mucosal contact to prevent trauma and bleeding. The entire aspiration process lasted 5-10 seconds. Physiological parameters and behavioral responses (N-PASS scores) were recorded before, during, and 10 minutes after the procedure.
干预措施: Non-Traumatic Nasopharyngeal Suction Procedure (Procedure)
Standard Suction Group
Infants in this group received routine oro/nasopharyngeal suctioning as performed in standard clinical practice.
A 6-8 Fr suction catheter was used without prior saline instillation. The catheter was inserted through the mouth and/or nostrils into the nasopharynx, and secretions were aspirated using 60-100 mmHg negative pressure.
The suction procedure lasted 5-10 seconds. The same physiological and behavioral parameters were monitored and recorded before, during, and after the procedure.
结局指标
主要结局
Change in Pain Score During Suctioning, N-PASS (Neonatal Pain, Agitation, and Sedation Scale) pain subscore
时间窗: During suctioning (within 1 minute of procedure start)
To evaluate and compare the level of pain experienced by preterm infants during suctioning using either the non-traumatic or standard technique. Pain Subscore: Range = 0 to 10, higher score = more pain.
次要结局
- Change in Oxygen Saturation (SpO₂) During and After Suctioning(During suctioning and 10 minutes post-procedure. SpO₂ measured by pulse oximetry.)
- Change in Heart Rate (HR) During and After Suctioning(During suctioning and 10 minutes post-procedure. Heart Rate measured using bedside monitor.)
- Change in Sedation Score During Suctioning,N-PASS sedation subscore,(During suctioning)
研究者
ebru temizsoy
Phd
Istanbul Bilgi University