## Protocol Section
### Identification Module
**NCT ID:** NCT06435572

**Brief Title:** Comparison of Open and Closed Aspiration in Newborns

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

#### Organization Study ID Info
**ID:** aslialaca
#### Organization
**Class:** OTHER
**Full Name:** Izmir Katip Celebi University
### Status Module
#### Completion Date
**Date:** 2025-12-21

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-24

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2025-06-21

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-06-21

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-21
**Study First Submit QC Date:** 2024-05-24
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Izmir Katip Celebi University

#### Responsible Party

**Investigator Affiliation:** Izmir Katip Celebi University

**Investigator Full Name:** Aslı Alaca

**Investigator Title:** MSc

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**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.

**Detailed 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.

### Conditions Module

**Conditions:**

- Newborn

**Keywords:**

- Closed system suctioning

- Open system suctioning

- Pain

- Neonatal intensive care

- Newborn

- Suction

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

**Intervention Model Description:** 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.

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 30

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 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.

**Intervention Names:**

- Other: Suction

**Label:** Experimental and A control group

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Experimental and A control group

**Description:** 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.

**Name:** Suction

**Other Names:**

- open suction

- closed suction

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** differences in pain between open and closed suctioning systems

**Measure:** Pain score

**Time Frame:** Pain will be evaluated before, during and 30 minutes after each suction procedure.

**Description:** differences in oxygen saturation between open and closed suctioning systems

**Measure:** Oxygen saturation

**Time Frame:** Oxygen saturation will be evaluated before, during and 30 minutes after each suction procedure

**Description:** differences in heart rate between open and closed suctioning systems

**Measure:** Heart rate

**Time Frame:** Heart rate will be evaluated before, during and 30 minutes after each aspiration procedure

### Eligibility Module

**Eligibility Criteria:** 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

**Minimum Age:** 1 Day

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** alaca_asli_1992@hotmail.com

**Name:** ASLI ALACA, MSc

**Phone:** 05062741676

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Buca

**Contacts:**

***Contact 1:***

- **Email:** alaca_asli_1992@hotmail.com

- **Name:** ASLI ALACA

- **Phone:** 05062741676

- **Role:** CONTACT

***Contact 2:***

- **Email:** alaca_asli_1992@hotmail.com

- **Phone Ext:** ALACA

- **Role:** CONTACT

***Contact 3:***

- **Name:** ASLI ALACA

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** Turkey

**Facility:** Aslı Alaca

**State:** İ̇zmi̇r- Turkey

**Status:** RECRUITING

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M13066

- Name: Pain

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
