Acute Upper Respiratory Tract Infectionsnasal lavageNCT07921680
Influence of Patient Positioning During Nasal Lavage
A study testing Supine position nasal lavage and Semi-sitting position nasal lavage in people with Acute Upper Respiratory Tract Infections and Nasal Obstruction, run by Hospital Universitario La Paz at 1 site in Spain.
Trial summary
Acute upper respiratory tract infections are the primary cause of pediatric visits and hospitalizations in young children. Nasal congestion and mucus accumulation often cause discomfort, feeding difficulties, and respiratory distress in infants. Read more about this study
- Who is it for?
- Ages 1 day to 2 years
- Conditions the study is for
- Acute Upper Respiratory Tract Infections, Nasal Obstruction, Bronchiolitis
- What is being tested?
- Supine position nasal lavage and Semi-sitting position nasal lavage
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 145 participants
- Where
- 1 siteSpain
- Study dates
- 15 Nov 2026to 1 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 1 day to 2 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Pediatric patients aged 0 to 2 years requiring nasal lavage in emergency or hospitalization settings for symptoms related to upper respiratory tract infections
- Modified TAL score <= 8 points (mild to moderate)
- Stable Pediatric Assessment Triangle (PAT), or if unstable, attributable exclusively to respiratory distress while maintaining adequate coloration and normal appearance
- Informed consent signed by parents
Who cannot join
- Absolute contraindications for nasal lavage (recent unstabilized nasal fractures, acute traumatic brain injury, swallowing disorders, ineffective cough or inability to cough, severe active nasal hemorrhage, unresolved tympanic membrane perforation, severe craniofacial anomalies)
- Post-operative period following recent nasal surgery (< 6 months since the surgical intervention)
- Chronic respiratory pathologies or chronic congenital pulmonary diseases (such as cystic fibrosis)
- Severe physical limitations preventing the safe adoption of any of the studied postures, or severe alteration of consciousness level/cognitive impairment preventing comprehension of instructions and collaboration.
- Patients who do not fully participate in the intervention.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site
Universitary La Paz Hospital
Madrid
Ana Martínez-Serrano, +34675115169, ana.martinez.serrano@salud.madrid.org
About this study
Official title: Influence of Patient Positioning During Nasal Lavage in Pediatric Patients: A Randomized Controlled Trial
Acute upper respiratory tract infections are the primary cause of pediatric visits and hospitalizations in young children. Nasal congestion and mucus accumulation often cause discomfort, feeding difficulties, and respiratory distress in infants. Nasal lavage using normal saline solution is widely recommended to clear upper airways; however, there is limited evidence regarding the optimal patient posture during irrigation.
This study aims to determine whether patient position-supine (lying on the back) versus sitting (tilted 10 degrees forward)-improves the effectiveness of nasal cavity clearance in children aged 0 to 2 years.
A randomized, parallel, age-stratified clinical trial will be conducted at Pediatric Emergency Department and in Pediatric Hospitalization at Universitary La Paz hospital. Participants will be pediatric patients with mild-to-moderate upper respiratory symptoms requiring nasal lavage as part of their routine care.
- Being tested
- Supine position nasal lavage, Semi-sitting position nasal lavage
- Keywords
- nasal lavage, pediatrics, respiratory tract infection, nasal irrigation
- Medical subject headings
- Nasal Obstruction, Bronchiolitis, Respiratory Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supine position nasal lavageProcedure or surgery
Lying position nasal irrigation
Semi-sitting position nasal lavageProcedure or surgery
Seated nasal irrigation 10 degrees forward
| Study group | Role | What they receive |
|---|---|---|
| Group A: Supine Position | Active comparator | Patients placed in supine position with the headboard flat and head turned to the side during normal saline nasal irrigation Receives: Procedure: Supine position nasal lavage |
| Group B: Semi-sitting Position | Experimental | Patients placed in a semi-sitting position, tilted 10 degrees forward and swaddled in a sheet during normal saline nasal irrigation Receives: Procedure: Semi-sitting position nasal lavage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness of nasal cavity cleaning according to the investigator
Visible expulsion of mucus or normal saline solution through nostril after irrigation
Measured: Periprocedural
Secondary outcomes (5)
Physiological parameters: Oxygen saturation
Changes in pulse oximetry oxygen saturation percentage
Measured: Periprocedural
Clinical severity assessed by the modified TAL score
Evaluation of respiratory distress using the validated modified TAL score (ranging from 0 to 12 points)
Measured: Baseline and immediately after the intervention
Incidence and type of adverse effects
Occurrence and classification of adverse effects experienced during or immediately after the technique, such as nasal bleeding (epistaxis), transient apnea, cyanosis, vomiting, or coughing.
Measured: Periprocedural
Physiological parameters: heart rate
Changes in patient heart rate
Measured: Baseline and immediately after the intervention
Physiological parameters: respiratory rate
Changes in patient respiratory rate
Measured: Baseline and immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2026
- Study start15 Nov 2026 (estimated)
- Primary completion1 May 2027 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Acute Upper Respiratory Tract InfectionsStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 145 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario La Paz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ana Martínez Serrano, Hospital Universitario La Paz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07921680
- Sponsor's protocol ID
- 2025.1018
- Acronym
- nasal lavage
- Status last verified
- Nov 2026
- First submitted
- 23 Oct 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Schmidt MN, Daugberg R, Nygaard U, Nielsen XC, Chawes B, Rytter MH, Schoos AM. Normal saline for children with bronchiolitis: study protocol for a randomised controlled non-inferiority trial. BMJ Paediatr Open. 2024 Jan 17;8(1):e002273. doi: 10.1136/bmjpo-2023-002273.
PubMed 38233083Martinez-Serrano A, Martinez-Campos P, Seijoso-Gonzalez L, Ruiz-Rojo H. Literature review of nasal lavage technique in paediatrics. Enferm Clin (Engl Ed). 2021 May-Jun;31(3):189-194. doi: 10.1016/j.enfcli.2021.01.005. Epub 2021 Feb 23. English, Spanish.
PubMed 33632624Cabaillot A, Vorilhon P, Roca M, Boussageon R, Eschalier B, Pereirad B. Saline nasal irrigation for acute upper respiratory tract infections in infants and children: A systematic review and meta-analysis. Paediatr Respir Rev. 2020 Nov;36:151-158. doi: 10.1016/j.prrv.2019.11.003. Epub 2020 Feb 21.
PubMed 32312677
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Patient Positioning During Nasal Lavage in Pediatric Patients: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07921680
- Acronym / sponsor ID
- nasal lavage / 2025.1018
- Keywords
- nasal lavage, pediatrics, respiratory tract infection, nasal irrigation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 145 participants (estimated)
- Lead sponsor
- Hospital Universitario La PazUniversity, hospital or other
- Study start
- 15 Nov 2026 (estimated)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 6 Nov 2026 (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.
Acute upper respiratory tract infections are the primary cause of pediatric visits and hospitalizations in young children. Nasal congestion and mucus accumulation often cause discomfort, feeding difficulties, and respiratory distress in infants. Nasal lavage using normal saline solution is widely recommended to clear upper airways; however, there is limited evidence regarding the optimal patient posture during irrigation.
This study aims to determine whether patient position-supine (lying on the back) versus sitting (tilted 10 degrees forward)-improves the effectiveness of nasal cavity clearance in children aged 0 to 2 years.
A randomized, parallel, age-stratified clinical trial will be conducted at Pediatric Emergency Department and in Pediatric Hospitalization at Universitary La Paz hospital. Participants will be pediatric patients with mild-to-moderate upper respiratory symptoms requiring nasal lavage as part of their routine care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: Supine Position | Active comparator | Procedure: Supine position nasal lavagePatients placed in supine position with the headboard flat and head turned to the side during normal saline nasal irrigation |
| Group B: Semi-sitting Position | Experimental | Procedure: Semi-sitting position nasal lavagePatients placed in a semi-sitting position, tilted 10 degrees forward and swaddled in a sheet during normal saline nasal irrigation |
Who may qualify
- Ages
- 1 day to 2 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Pediatric patients aged 0 to 2 years requiring nasal lavage in emergency or hospitalization settings for symptoms related to upper respiratory tract infections
- Modified TAL score <= 8 points (mild to moderate)
- Stable Pediatric Assessment Triangle (PAT), or if unstable, attributable exclusively to respiratory distress while maintaining adequate coloration and normal appearance
- Informed consent signed by parents
Key exclusion criteria (5 listed)
- Absolute contraindications for nasal lavage (recent unstabilized nasal fractures, acute traumatic brain injury, swallowing disorders, ineffective cough or inability to cough, severe active nasal hemorrhage, unresolved tympanic membrane perforation, severe craniofacial anomalies)
- Post-operative period following recent nasal surgery (< 6 months since the surgical intervention)
- Chronic respiratory pathologies or chronic congenital pulmonary diseases (such as cystic fibrosis)
- Severe physical limitations preventing the safe adoption of any of the studied postures, or severe alteration of consciousness level/cognitive impairment preventing comprehension of instructions and collaboration.
- Patients who do not fully participate in the intervention.
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 |
|---|---|---|
| Supine position nasal lavageLying position nasal irrigation | Procedure or surgery | Group A: Supine Position |
| Semi-sitting position nasal lavageSeated nasal irrigation 10 degrees forward | Procedure or surgery | Group B: Semi-sitting Position |
Primary outcome
Effectiveness of nasal cavity cleaning according to the investigator
Time frame: Periprocedural
Visible expulsion of mucus or normal saline solution through nostril after irrigation
5 secondary outcomes
Physiological parameters: Oxygen saturation
Time frame: Periprocedural
Clinical severity assessed by the modified TAL score
Time frame: Baseline and immediately after the intervention
Incidence and type of adverse effects
Time frame: Periprocedural
Physiological parameters: heart rate
Time frame: Baseline and immediately after the intervention
Physiological parameters: respiratory rate
Time frame: Baseline and immediately after the intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Results publication: PubMed 38233083Schmidt MN, Daugberg R, Nygaard U, Nielsen XC, Chawes B, Rytter MH, Schoos AM. Normal saline for children with bronchiolitis: study protocol for a randomised controlled non-inferiority trial. BMJ Paediatr Open. 2024 Jan 17;8(1):e002273. doi: 10.1136/bmjpo-2023-002273.
- Results publication: PubMed 33632624Martinez-Serrano A, Martinez-Campos P, Seijoso-Gonzalez L, Ruiz-Rojo H. Literature review of nasal lavage technique in paediatrics. Enferm Clin (Engl Ed). 2021 May-Jun;31(3):189-194. doi: 10.1016/j.enfcli.2021.01.005. Epub 2021 Feb 23. English, Spanish.
- Results publication: PubMed 32312677Cabaillot A, Vorilhon P, Roca M, Boussageon R, Eschalier B, Pereirad B. Saline nasal irrigation for acute upper respiratory tract infections in infants and children: A systematic review and meta-analysis. Paediatr Respir Rev. 2020 Nov;36:151-158. doi: 10.1016/j.prrv.2019.11.003. Epub 2020 Feb 21.
- Individual participant dataSharing planned: No
Related trials for Acute Upper Respiratory Tract Infections
Recruiting
Vocxi Breath Analyzer Study in Pediatric Respiratory Infection
Acute Respiratory Illness, Viral Respiratory Infection
Not yet recruiting
Enhanced Telemedicine in Primary Care for Acute Respiratory Tract Infections Study
Acute Respiratory Tract Infection, Ear Infection
Recruiting
Acute Cryotherapy on Musculoskeletal Function and Biomarkers
Exercise Induced Muscle Damage, Cryotherapy
Not yet recruiting
Cold Water Papillary Irrigation Plus Rectal NSAIDs vs Rectal NSAIDs Alone for Post-ERCP Pancreatitis (COLD)
Post ERCP Pancreatitis, Acute Pancreatitis (AP)
Recruiting
Artificial Intelligence Diagnostic Decision Support to Reduce Antimicrobial Prescriptions in Young Children With Colds
Acute Otitis Media (AOM), Upper Respiratory Infection
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supine position nasal lavage and Semi-sitting position nasal lavage in people with Acute Upper Respiratory Tract Infections and Nasal Obstruction, run by Hospital Universitario La Paz at 1 site in Spain.
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 4 inclusion and 5 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: opening soon, as of the sponsor's last update on 6 Nov 2026. 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 Spain. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ana Martínez-Serrano, phD pediatric nurse (+34675115169, ana.martinez.serrano@salud.madrid.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness of nasal cavity cleaning according to the investigator (time frame: Periprocedural). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07921680, which also lists 3 linked publications.
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 6 Nov 2026.