Determining The Effects Of Nasopharyngeal Suction

NCT06020638 | Completed

• 1 other identifier: 2020/0072
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Objective: The aim of the study is to determine the effects of nasopharyngeal suction with negative and positive pressure on the pain level, respiratory parameters, and mucosal irritation in infants. Materials and Methods: This study was conducted as a posttest randomised controlled experimental research. The data were collected at XX Training and Research Hospital between January and November 2020. While the positive pressure suction method was applied to the experimental group, the negative pressure suction method was applied to the control group.

Conditions

Aspiration, Respiratory; Pain; Mucosal Irritation; Infant

Outcome Measures

Primary Outcomes (3)

• Pain

  Determining the pain level with the Wong-Baker Faces Pain Rating Scale. Wong-Baker FACES Pain Rating Scale (Wong \& Baker, 1988) is an adaptation of the "Faces Rating Scale" which is a picture projection technique for assessing child pain and utilizes 6 illustrations of faces that a child in pain uses to best describe their present level of pain. Face 0 depicts a happy face with no pain. Face 5 depicts a crying face that "hurts as much as you can imagine, although you don't have to be crying to feel this bad." Responses on the 5-point scale range from 0 (very happy, no hurt) to 5 (hurts as much as you can imagine).

  Before the suction procedure 1st minute after the procedure 5st minute after the procedure 15st minute after the procedure

• Respiratory Parameters

  Determining The Effect of Suction on SpO2 level

  Before the suction procedure 1st minute after the procedure 5st minute after the procedure 15st minute after the procedure

• Mucosal İrritation

  Determining The Existence of Mucosal İrritation (bleeding or absent)

  Before the suction procedure 1st minute after the procedure 5st minute after the procedure 15st minute after the procedure

Study Arms (2)

Experimental group (Positive Pressure Group)

EXPERIMENTAL

The nasopharyngeal suction with positive pressure method was employed in the sample group. In this method, the infant's head is turned to the side, to the nostril on the other side 1-2 ml of physiological saline (PS- Mustela trademark), is injected with a 2,5-milliliter syringe (Can Medikal trademark), and then positive pressure is exerted with the help of the end of the oxygen connection hose (CGR Medikal trademark) from the same nostril, with oxygen or air supply at 5-8 lt/min (liter/minute) (if the baby requires oxygen, using an oxygen source) and the nasopharyngeal secretions are removed from the nostril into which physiological saline (PS) has been not injected. The oxygen connection hose is held one centimeter away from the infant's nostril. The researchers prepared a guideline for nasopharyngeal suction with positive pressure based on the literature.

Device: Experimental group

Control group (Negative Pressure Group)

ACTIVE COMPARATOR

The nasopharyngeal suction with negative pressure method was employed in the control group in this study. In this method, the nasal secretions were softened with 1-2 ml of physiological saline (PS- Mustela trademark) like experimental group, and then negative pressure suction was performed using a pine-tipped suction set (Bıcakcılar trademark). The suction pressure was kept between 60 and 80 mmHg, and no suction lasted for more than 15 seconds

Device: control group

Interventions

Experimental group DEVICE

THE EFFECTS OF NASOPHARYNGEAL SUCTION POSITIVE PRESSURE

Experimental group (Positive Pressure Group)

control group DEVICE

THE EFFECTS OF NASOPHARYNGEAL SUCTION NEGATIVE PRESSURE

Control group (Negative Pressure Group)

Eligibility Criteria

• Age: 37 Weeks - 40 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Existence of secretion

You may not qualify if:

• Being premature
• without family consent

Sponsors & Collaborators

• Fenerbahce University: lead

Study Sites (1)

Istanbul Medeniyet University Goztepe Hospital

Istanbul, Kadiköy, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Respiratory Aspiration; Pain

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• kokkiz

  Fenerbahce University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Model Details: This study was designed as randomized, controlled, and experimental

Study Record Dates

• First Submitted: August 16, 2023
• First Posted: August 31, 2023
• Study Start: January 15, 2023
• Primary Completion: March 11, 2023
• Study Completion: May 12, 2023
• Last Updated: August 31, 2023

Record last verified: 2023-08

Locations

TU (1)