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Not yet recruitingNCT07921680nasal lavageUpdated Nov 6, 2026

Influence of Patient Positioning During Nasal Lavage

An interventional study of Supine position nasal lavage and Semi-sitting position nasal lavage in Acute Upper Respiratory Tract Infections, Nasal Obstruction and Bronchiolitis, sponsored by Hospital Universitario La Paz. Not yet recruiting at 1 site in Spain. Open to participants aged 1 Day to 2 Years. Per ClinicalTrials.gov, last updated 2026-11-06.

Sponsored by Hospital Universitario La Paz · Not applicable, Interventional, and Treatment

Updated Nov 6, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
145
Allocation
Randomized
Ages
1 Day to 2 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Acute Upper Respiratory Tract Infections
  • Nasal Obstruction
  • Bronchiolitis

Keywords

  • nasal lavage
  • pediatrics
  • respiratory tract infection
  • nasal irrigation
03

In context

Nasal Obstruction

173 studies on the registry are indexed under Nasal Obstruction; 31 are open to participants now.

This study's planned enrollment of 145 is above the median of 70 across 139 interventional studies indexed under Nasal Obstruction.

Browse Nasal Obstruction studies →

Lead sponsor

Hospital Universitario La Paz is the lead sponsor of 56 studies on the registry; 20 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Day to 2 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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
  • signed by parents

Exclusion criteria

Exclusion Criteria:

  • Absolute 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.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
145 participants (estimated)

Study arms

  • Active comparator
    Group A: Supine Position

    Patients placed in supine position with the headboard flat and head turned to the side during normal saline nasal irrigation

    Procedure: Supine position nasal lavage

  • Experimental
    Group B: Semi-sitting Position

    Patients placed in a semi-sitting position, tilted 10 degrees forward and swaddled in a sheet during normal saline nasal irrigation

    Procedure: Semi-sitting position nasal lavage

Interventions

  • ProcedureSupine position nasal lavage

    Lying position nasal irrigation

  • ProcedureSemi-sitting position nasal lavage

    Seated nasal irrigation 10 degrees forward

06

What researchers measure

Primary outcomes

  1. Effectiveness of nasal cavity cleaning according to the investigator

    Visible expulsion of mucus or normal saline solution through nostril after irrigation

    Time frame: Periprocedural

Secondary outcomes

  1. Physiological parameters: Oxygen saturation

    Changes in pulse oximetry oxygen saturation percentage

    Time frame: Periprocedural

  2. Clinical severity assessed by the modified TAL score

    Evaluation of respiratory distress using the validated modified TAL score (ranging from 0 to 12 points)

    Time frame: Baseline and immediately after the intervention

  3. 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.

    Time frame: Periprocedural

  4. Physiological parameters: heart rate

    Changes in patient heart rate

    Time frame: Baseline and immediately after the intervention

  5. Physiological parameters: respiratory rate

    Changes in patient respiratory rate

    Time frame: Baseline and immediately after the intervention

07

Study locations

1 site
08

References and documents

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 38233083 ↗
  • Martinez-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 33632624 ↗
  • Cabaillot 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 ↗

Individual participant data

Plan to share: No

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Nov 6, 2026
Show all 1 update
  1. Nov 6, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07921680
Lead sponsor
Hospital Universitario La Paz
Responsible party
Ana Martínez Serrano (Principal investigator, Hospital Universitario La Paz) — Principal investigator
First posted
Nov 6, 2026
Start date
Nov 15, 2026 (estimated)
Primary completion
May 1, 2027 (estimated)
Completion
May 1, 2027 (estimated)
Last update
Nov 6, 2026

Study contacts

Ana Martínez-Serrano, phD pediatric nurse
Contact
ana.martinez.serrano@salud.madrid.org
+34675115169

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.

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