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临床试验/NCT06020638
NCT06020638已完成不适用

Determining The Effects Of Nasopharyngeal Suction With Negative And Positive Pressure: Randomised Conrolled Trial

Fenerbahce University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年1月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
Pain

研究概览

简要总结

Objective: The aim of the study is to determine the effects of nasopharyngeal suction with negative and positive pressure on the pain level, respiratory parameters, and mucosal irritation in infants.

Materials and Methods: This study was conducted as a posttest randomised controlled experimental research. The data were collected at XX Training and Research Hospital between January and November 2020. While the positive pressure suction method was applied to the experimental group, the negative pressure suction method was applied to the control group.

详细描述

Nurses are responsible for suction function to clear the airway from secretions for effective breathing. Suction is defined as the removal of secretions of the respiratory system with a negative pressure vacuum device. In patients who are unable to extract respiratory secretions independently, suction is essential to maintain the oxygen demand and ventilation at the desired level and remove these secretions.

The infant's respiratory and circulatory systems may be adversely affected as a result of the suction procedure, and several complications such as trauma, haemorrhage, and pain may develop. Suction is therefore one of the procedures that should be applied with caution in infants. Suction procedures for the respiratory tract in infants include oro/nasopharyngeal and endotracheal suction and suction methods include open and closed system suction methods.

Oro/nasopharyngeal suction is a method that requires the use of negative pressure to remove secretions from the oropharynx, nasopharynx, or both. When a foreign body penetrates the trachea from the pharynx, when respiratory secretions are too much, or when the secretion cannot be removed by normal cilia movement, coughing holds an important role. Inability to cough leads to atelectasis, pneumonia, and respiratory failure during infection of the respiratory tract. The cough reflex matures around the age of five in children. Adults are able to quickly remove existing airway secretions, but children with excessive airway secretions prior to this age are unable to do so easily. These secretions may be removed through either nasopharyngeal or oropharyngeal suction.

There are several risks and complications associated with suction procedure. The most common are hypoxia, bradycardia, tachycardia, hypotension, hypertension, cardiac arrhythmia, cardiac arrest, atelectasis, bronchospasm, elevated intracranial pressure, nosocomial infection, tracheobronchial damage, and pain. Hypoxemia is the most prevalent and serious complication among them. To avoid the suction-induced hypoxemia, different suction methods are being developed and novel devices are being employed.Suction, a painful procedure, has been reported to negatively impact the physiological parameters, comfort, sleep, growth, and hospital stay of infants. The primary goal of pain management in infants is to minimise the pain experienced by infants due to various medical procedures and allow them to cope with the pain.

When the literature was reviewed, it was observed that the respiratory rate, heart rate, SpO2 and tidal volumes of the patients were assessed as respiratory parameters, while spirometry was utilized to assess respiratory function.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
37 Weeks 至 40 Weeks(Child)
性别
All
接受健康志愿者
是

入选标准

  • •Existence of secretion

排除标准

  • •Being premature
  • •without family consent

研究组 & 干预措施

Experimental group (Positive Pressure Group)

Experimental

The nasopharyngeal suction with positive pressure method was employed in the sample group. In this method, the infant's head is turned to the side, to the nostril on the other side 1-2 ml of physiological saline (PS- Mustela trademark), is injected with a 2,5-milliliter syringe (Can Medikal trademark), and then positive pressure is exerted with the help of the end of the oxygen connection hose (CGR Medikal trademark) from the same nostril, with oxygen or air supply at 5-8 lt/min (liter/minute) (if the baby requires oxygen, using an oxygen source) and the nasopharyngeal secretions are removed from the nostril into which physiological saline (PS) has been not injected. The oxygen connection hose is held one centimeter away from the infant's nostril. The researchers prepared a guideline for nasopharyngeal suction with positive pressure based on the literature.

干预措施: Experimental group (Device)

Control group (Negative Pressure Group)

Active Comparator

The nasopharyngeal suction with negative pressure method was employed in the control group in this study. In this method, the nasal secretions were softened with 1-2 ml of physiological saline (PS- Mustela trademark) like experimental group, and then negative pressure suction was performed using a pine-tipped suction set (Bıcakcılar trademark). The suction pressure was kept between 60 and 80 mmHg, and no suction lasted for more than 15 seconds

干预措施: control group (Device)

结局指标

主要结局

Pain

时间窗: Before the suction procedure 1st minute after the procedure 5st minute after the procedure 15st minute after the procedure

Determining the pain level with the Wong-Baker Faces Pain Rating Scale. Wong-Baker FACES Pain Rating Scale (Wong \& Baker, 1988) is an adaptation of the "Faces Rating Scale" which is a picture projection technique for assessing child pain and utilizes 6 illustrations of faces that a child in pain uses to best describe their present level of pain. Face 0 depicts a happy face with no pain. Face 5 depicts a crying face that "hurts as much as you can imagine, although you don't have to be crying to feel this bad." Responses on the 5-point scale range from 0 (very happy, no hurt) to 5 (hurts as much as you can imagine).

Respiratory Parameters

时间窗: Before the suction procedure 1st minute after the procedure 5st minute after the procedure 15st minute after the procedure

Determining The Effect of Suction on SpO2 level

Mucosal İrritation

时间窗: Before the suction procedure 1st minute after the procedure 5st minute after the procedure 15st minute after the procedure

Determining The Existence of Mucosal İrritation (bleeding or absent)

次要结局

未报告次要终点

研究者

发起方
Fenerbahce University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Rukiye Kokkiz

Research Assistant

Fenerbahce University

研究点 (1)

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