Effects of Non-Traumatic Nasopharyngeal Suction Technique in Infants

NCT ID: NCT07111611

Last Updated: 2025-08-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-01
• Study Completion Date: 2020-01-01

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.

Detailed Description

This randomized controlled clinical trial was conducted to evaluate the effectiveness of a newly developed non-traumatic oro/nasopharyngeal suction technique in preterm infants receiving non-invasive ventilation (NIV). Traditional suction methods used to remove airway secretions in neonates are often associated with complications such as mucosal trauma, bradycardia, hypoxia, and increased pain.

The non-traumatic technique involves administering a small volume of sterile saline through one nostril and using gentle suction from the other nostril or the mouth without direct mucosal contact. This approach is designed to minimize trauma and discomfort.

A total of 100 preterm infants with gestational ages between 32 0/6 and 36 6/7 weeks were included and randomized into two groups: an intervention group receiving the non-traumatic suction method and a control group undergoing standard suction. Key outcome measures included physiological parameters (heart rate, respiratory rate, SpO₂, skin color) and behavioral indicators assessed using the Neonatal Pain, Agitation, and Sedation Scale (N-PASS). Data were collected before, during, and after suctioning procedures.

Conditions

Preterm

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Non-Traumatic Suction Group

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.

Group Type: EXPERIMENTAL

Non-Traumatic Nasopharyngeal Suction Procedure

Intervention Type: 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.

Standard Suction Group

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Non-Traumatic Nasopharyngeal Suction 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.

Intervention Type: PROCEDURE

Other Intervention Names

Non-traumatic Suction Technique

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 32 Weeks
• Maximum Eligible Age: 37 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Istanbul Bilgi University

OTHER

Sponsor Role: lead

Responsible Party

ebru temizsoy

Phd

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ebru Temizsoy, PhD,RN

Role: PRINCIPAL_INVESTIGATOR

İstanbul Bilgi University

Locations

İstanbul Bilgi University

Şişli, Istanbul, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

159

Identifier Type: -

Identifier Source: org_study_id