Comparison of Open and Closed Aspiration in Newborns

NCT06435572 | Recruiting DMC

• 1 other identifier: aslialaca
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Newborn

Keywords

Closed system suctioning; Open system suctioning; Pain; Neonatal intensive care; Newborn; Suction

Outcome Measures

Primary Outcomes (3)

• Pain score

  differences in pain between open and closed suctioning systems

  Pain will be evaluated before, during and 30 minutes after each suction procedure.

• 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

• 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

Study Arms (1)

Experimental and A control group

EXPERIMENTAL

Each patient will be evaluated as both the experimental and control group. In line with the patient's aspiration needs, two different suction methods will be applied and the effects of the methods will be evaluated on the same patient. In the study, open suction applied to the patient will be considered as the control group, and closed suction will be considered as the experimental group. The first suction of the same patient during the day will be performed as open suction, and the second suction will be performed as closed suction. Pain and physiological parameters will be evaluated before, during and 30 minutes after each sucking session.

Other: Suction

Interventions

Suction OTHER

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.

Also known as: open suction, closed suction

Experimental and A control group

Eligibility Criteria

• Age: 1 Day+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Newborns monitored with mechanical ventilation
• Newborn who need suctioning,
• Newborn who did not undergo painful procedures one hour before aspiration.
• Hemodynamically stable newborn;

You may not qualify if:

• Newborn with any facial/skull deformities
• Newborn with chromosomal/genetic abnormalities

Sponsors & Collaborators

• Izmir Katip Celebi University: lead

Study Sites (1)

Aslı Alaca

Buca, İ̇zmi̇r- Turkey, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Pain

Interventions

Suction

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Drainage; Surgical Procedures, Operative

Central Study Contacts

ASLI ALACA, MSc

CONTACT

05062741676; alaca_asli_1992@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MSc

Model Details: Each patient will be considered as both an experimental and a control group.Two different aspiration methods will be applied in line with the patient's aspiration needs, and the effect of the methods will be evaluated on the same patient. In the study, open aspiration applied to the patient will be evaluated as control, and closed aspiration will be considered as the experimental group.

Study Record Dates

• First Submitted: May 21, 2024
• First Posted: May 30, 2024
• Study Start: June 21, 2024
• Primary Completion: June 21, 2025
• Study Completion: December 21, 2025
• Last Updated: May 30, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)