Comparison of Open and Closed Aspiration in Newborns

Newborn Clinical Trial

Official title:

Effect of Open and Closed Suction Systems on Newborn's Pain and Vital Signs in Neonatal Intensive Care

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06435572
• Other study ID #: aslialaca
• Status: Recruiting
• Phase: N/A
• Start date: June 21, 2024
• Est. completion date: December 21, 2025

Study information

• Verified date: May 2024
• Source: Izmir Katip Celebi University
• Contact: ASLI ALACA, MSc
• Phone: 05062741676
• Email: alaca_asli_1992[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Endotracheal aspiration is a necessary procedure performed by nurses in neonatal intensive care units to increase oxygenation and remove secretions from the airways. It is one of the painful procedures that most frequently causes stress in intubated newborns.

Description:

The aim of this study is to examine the effect of open and closed system suction, which is one of the invasive procedures frequently applied in neonatal intensive care, on the baby's pain and vital signs. There is a need for innovative, evidence-based practices to be implemented by nurses in clinics to minimize complications related to endotracheal suction.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 21, 2025
• Est. primary completion date: June 21, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Day and older

Eligibility

Inclusion Criteria:

• Newborns monitored with mechanical ventilation

• Newborn who need suctioning,

• Newborn who did not undergo painful procedures one hour before aspiration.

• Hemodynamically stable newborn;

Exclusion Criteria:

• Newborn with any facial/skull deformities

• Newborn with chromosomal/genetic abnormalities

Related Conditions & MeSH terms

• Newborn

Intervention

Other:
• Suction
Each patient will be evaluated as both the experimental and control group. In the study, open suction applied to the patient will be evaluated as control, and closed suction will be considered as the experimental group. The first suction of the same patient during the day will be done as open suction, and the second suction will be done as closed suction.

Locations

Country	Name	City	State
Turkey	Asli Alaca	Buca	I?zmi?r- Turkey

Sponsors (1)

Lead Sponsor	Collaborator
Izmir Katip Celebi University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain score	differences in pain between open and closed suctioning systems	Pain will be evaluated before, during and 30 minutes after each suction procedure.
Primary	Oxygen saturation	differences in oxygen saturation between open and closed suctioning systems	Oxygen saturation will be evaluated before, during and 30 minutes after each suction procedure
Primary	Heart rate	differences in heart rate between open and closed suctioning systems	Heart rate will be evaluated before, during and 30 minutes after each aspiration procedure