Aspiration, RespiratoryNCT06020638
Determining The Effects Of Nasopharyngeal Suction
A study testing Experimental group in people with Aspiration, Respiratory and Pain, run by Fenerbahce University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 37 to 40 weeksHealthy volunteers can take part
- Conditions the study is for
- Aspiration, Respiratory, Pain, Mucosal Irritation
- What is being tested?
- Experimental group
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jan 2023to 12 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 37 to 40 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Existence of secretion
Who cannot join
- Being premature
- without family consent
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Medeniyet University Goztepe Hospital
Istanbul, Kadiköy
About this study
Official title: Determining The Effects Of Nasopharyngeal Suction With Negative And Positive Pressure: Randomised Conrolled Trial
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.
Read the detailed 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.
- Conditions
- Aspiration, Respiratory, Pain, Mucosal Irritation, Infant
- Being tested
- Experimental group, control group
- Medical subject headings
- Respiratory Aspiration, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental groupDevice
THE EFFECTS OF NASOPHARYNGEAL SUCTION POSITIVE PRESSURE
control groupDevice
THE EFFECTS OF NASOPHARYNGEAL SUCTION NEGATIVE PRESSURE
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Experimental group |
| 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 Receives: Device: control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain
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).
Measured: Before the suction procedure 1st minute after the procedure 5st minute after the procedure 15st minute after the procedure
Respiratory Parameters
Determining The Effect of Suction on SpO2 level
Measured: Before the suction procedure 1st minute after the procedure 5st minute after the procedure 15st minute after the procedure
Mucosal İrritation
Determining The Existence of Mucosal İrritation (bleeding or absent)
Measured: Before the suction procedure 1st minute after the procedure 5st minute after the procedure 15st minute after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2023
- Study start15 Jan 2023
- Primary completion11 Mar 2023
- Study completion12 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aspiration, RespiratoryStudies of the same condition, open and under way.
- More trials run by Fenerbahce UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This study was designed as randomized, controlled, and experimental
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fenerbahce University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rukiye Kokkiz, Fenerbahce University
- Investigators
- kokkiz, Study director, Fenerbahce University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06020638
- Sponsor's protocol ID
- 2020/0072
- Status last verified
- Aug 2023
- First submitted
- 16 Aug 2023
- Last updated
- 31 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining The Effects Of Nasopharyngeal Suction With Negative And Positive Pressure: Randomised Conrolled Trial
- ClinicalTrials.gov ID
- NCT06020638
- Acronym / sponsor ID
- 2020/0072
- Conditions
- Aspiration, Respiratory, Pain, Mucosal Irritation, Infant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Fenerbahce UniversityUniversity, hospital or other
- Study start
- 15 Jan 2023 (actual)
- Primary completion
- 11 Mar 2023 (actual)
- Study completion
- 12 May 2023 (actual)
- First posted
- 31 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study was designed as randomized, controlled, and experimental
| Arm | Type | Receives |
|---|---|---|
| Experimental group (Positive Pressure Group) | Experimental | Device: Experimental groupThe 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. |
| Control group (Negative Pressure Group) | Active comparator | Device: control groupThe 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 |
Who may qualify
- Ages
- 37 to 40 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Existence of secretion
Key exclusion criteria (2 listed)
- Being premature
- without family consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental groupTHE EFFECTS OF NASOPHARYNGEAL SUCTION POSITIVE PRESSURE | Device | Experimental group (Positive Pressure Group) |
| control groupTHE EFFECTS OF NASOPHARYNGEAL SUCTION NEGATIVE PRESSURE | Device | Control group (Negative Pressure Group) |
Primary outcome
Pain
Time frame: 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
Time frame: 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
Time frame: 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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
kokkiz study director
Fenerbahce University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental group in people with Aspiration, Respiratory and Pain, run by Fenerbahce University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain (time frame: Before the suction procedure 1st minute after the procedure 5st minute after the procedure 15st minute after the procedure). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2023; AzTrials last refreshed its copy on 6 Nov 2026.