Influence of Patient Positioning During Nasal Lavage (nasal lavage)

November 1, 2026 updated by: Ana Martínez Serrano, Hospital Universitario La Paz

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

145

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 2 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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
  • Informed consent signed by parents

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

Lying position nasal irrigation
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

Seated nasal irrigation 10 degrees forward

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effectiveness of nasal cavity cleaning according to the investigator
Time Frame: Periprocedural

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physiological parameters: Oxygen saturation
Time Frame: Periprocedural

Changes in pulse oximetry oxygen saturation percentage
Periprocedural
Clinical severity assessed by the modified TAL score
Time Frame: Baseline and immediately after the intervention

Evaluation of respiratory distress using the validated modified TAL score (ranging from 0 to 12 points)
Baseline and immediately after the intervention
Incidence and type of adverse effects
Time Frame: Periprocedural

Occurrence and classification of adverse effects experienced during or immediately after the technique, such as nasal bleeding (epistaxis), transient apnea, cyanosis, vomiting, or coughing.
Periprocedural
Physiological parameters: heart rate
Time Frame: Baseline and immediately after the intervention

Changes in patient heart rate
Baseline and immediately after the intervention
Physiological parameters: respiratory rate
Time Frame: Baseline and immediately after the intervention

Changes in patient respiratory rate
Baseline and immediately after the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Universitario La Paz

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 15, 2026

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

May 1, 2027

Study Registration Dates

First Submitted

October 23, 2026

First Submitted That Met QC Criteria

November 1, 2026

First Posted (Actual)

November 6, 2026

Study Record Updates

Last Update Posted (Actual)

November 6, 2026

Last Update Submitted That Met QC Criteria

November 1, 2026

Last Verified

November 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025.1018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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