Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT06020638 |
Other study ID # |
2020/0072 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
January 15, 2023 |
Est. completion date |
May 12, 2023 |
Study information
Verified date |
August 2023 |
Source |
Fenerbahce University |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
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.
Description:
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.
Trauma is another complication of negative pressure suction. Suctioning of the tracheal,
oral, and nasopharyngeal mucosa caused by negative pressure may result in haemorrhage and
ulceration. As a result of the increased vacuum pressure generated during suction, the
mucosal fragments are displaced from the catheter holes and absorbed.
Objective This study aimed to determine the effects of nasopharyngeal suction with negative
and positive pressure on the level of pain, respiratory parameters, and mucosal irritation in
infants.
Research Hypotheses H0: There is no difference between positive pressure nasopharyngeal
aspiration procedure and negative pressure nasopharyngeal aspiration procedure.
H1: The level of pain felt by infants during nasopharyngeal suction with positive pressure is
lower than the level of pain they suffer during nasopharyngeal suction with negative
pressure.
H2: In infants, the SpO2 level after nasopharyngeal suction with positive pressure is higher
than the SpO2 level following nasopharyngeal suction with negative pressure.
H3: In infants, the respiratory rate after nasopharyngeal suction with positive pressure is
less affected than the respiratory rate following nasopharyngeal suction with negative
pressure.
H4: In infants, the mucosal irritation caused by the nasopharyngeal suction with positive
pressure is less than the mucosal irritation caused by the nasopharyngeal suction with
negative pressure.