Effects of Non-Traumatic Nasopharyngeal Suction Technique in Infants

NCT07111611 | Completed

• 1 other identifier: 159
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Non-invasive ventilation (NIV) in preterm infants often leads to secretion-related airway obstructions, requiring suctioning. Traditional oro/nasopharyngeal suction techniques may cause mucosal trauma, pain, and physiological instability. Objective: To evaluate the effects of a novel non-traumatic oro/nasopharyngeal suction technique on physiological and behavioral parameters in preterm infants receiving NIV. Methods: A randomized controlled trial was conducted with 100 preterm infants (32 0/6 - 36 6/7 weeks gestation) admitted to a Level IV NICU. Infants were randomized into intervention (non-traumatic suction) and control (routine suction) groups. Data on heart rate, respiratory rate, SpO₂, skin color, and pain/sedation scores (N-PASS) were collected before, during, and after suctioning.

Conditions

Preterm

Keywords

non-invasive ventilation; preterm infant; suction; pain; physological parameters

Outcome Measures

Primary Outcomes (1)

• Change in Pain Score During Suctioning, N-PASS (Neonatal Pain, Agitation, and Sedation Scale) pain subscore

  To evaluate and compare the level of pain experienced by preterm infants during suctioning using either the non-traumatic or standard technique. Pain Subscore: Range = 0 to 10, higher score = more pain.

  During suctioning (within 1 minute of procedure start)

Secondary Outcomes (3)

• Change in Oxygen Saturation (SpO₂) During and After Suctioning

  During suctioning and 10 minutes post-procedure. SpO₂ measured by pulse oximetry.

• Change in Heart Rate (HR) During and After Suctioning

  During suctioning and 10 minutes post-procedure. Heart Rate measured using bedside monitor.

• Change in Sedation Score During Suctioning,N-PASS sedation subscore,

  During suctioning

Study Arms (2)

Non-Traumatic Suction Group

EXPERIMENTAL

Infants in this group underwent a non-traumatic oro/nasopharyngeal suction procedure. A 10 Fr suction catheter with a blunt-cut tip and a 10 ml syringe were used. Depending on secretion amount and thickness, 5-10 ml of 0.9% saline was rapidly instilled through one nostril. Secretions were then aspirated using 150-200 mmHg negative pressure via the opposite nostril and the mouth, without deep catheter insertion. Physiological parameters (heart rate, respiratory rate, oxygen saturation, skin color) and behavioral responses (N-PASS pain and sedation scores) were recorded before, during, and 10 minutes after the procedure.opposite nostril and the mouth, without deep catheter insertion. The procedure was carefully performed without mucosal contact to prevent trauma and bleeding. The entire aspiration process lasted 5-10 seconds. Physiological parameters and behavioral responses (N-PASS scores) were recorded before, during, and 10 minutes after the procedure.

Procedure: Non-Traumatic Nasopharyngeal Suction Procedure

Standard Suction Group

NO INTERVENTION

Infants in this group received routine oro/nasopharyngeal suctioning as performed in standard clinical practice. A 6-8 Fr suction catheter was used without prior saline instillation. The catheter was inserted through the mouth and/or nostrils into the nasopharynx, and secretions were aspirated using 60-100 mmHg negative pressure. The suction procedure lasted 5-10 seconds. The same physiological and behavioral parameters were monitored and recorded before, during, and after the procedure.

Interventions

Non-Traumatic Nasopharyngeal Suction Procedure PROCEDURE

A modified suctioning technique that avoids deep catheter insertion and minimizes mucosal contact. Sterile saline (0.9%) is instilled into one nostril, and secretions are aspirated using external suction via the opposite nostril or mouth. This approach is designed to reduce pain and physiological stress compared to standard suction methods in preterm infants undergoing non-invasive ventilation.

Also known as: Non-traumatic Suction Technique

Non-Traumatic Suction Group

Eligibility Criteria

• Age: 32 Weeks - 37 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Gestational age between 32 0/6 and 36 6/7 weeks
• Receiving non-invasive ventilation (NIV) via nasal CPAP
• Clinically stable prior to suctioning
• Parental or legal guardian informed consent obtained
• Age within first 7 days of life at time of first suction procedure

You may not qualify if:

• Major congenital anomalies (e.g., craniofacial malformations, cardiac defects)
• Suspected or confirmed neurological disorders (e.g., intraventricular hemorrhage Grade III/IV)
• Presence of upper airway obstruction or nasal anomalies
• Infants requiring invasive mechanical ventilation at the time of study
• Any condition requiring continuous sedation or analgesia
• Hemodynamically unstable infants (e.g., hypotension requiring inotropes)
• Parental refusal or withdrawal of consent

Sponsors & Collaborators

• Istanbul Bilgi University: lead

Study Sites (1)

İstanbul Bilgi University

Şişli, Istanbul, 34387, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Premature Birth; Pain

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ebru Temizsoy, PhD,RN

  İstanbul Bilgi University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Single (Investigator)
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Phd

Model Details: Parallel Assignment Randomized Controlled two groups (control group and study group)

Study Record Dates

• First Submitted: May 25, 2025
• First Posted: August 8, 2025
• Study Start: January 1, 2018
• Primary Completion: January 1, 2019
• Study Completion: January 1, 2020
• Last Updated: August 8, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)