Facilitated Tucking Position During Endotracheal Suctioning

The Effect of Facilitated Tucking Position During Endotracheal Suctioning on Physiological Measurement and Behavioral Responses of the Preterm Neonates

Aim of the present study The present study will aimed to determine the effect of facilitated tucking position during endotracheal suctioning on physiological criteria and behavioural responses of the preterm neonates.

Research Hypotheses

1. Preterm neonates who receive facilitated tucking position during endotracheal suctioning exhibit more stable physiological criteria than those who do not.
2. Preterm neonates who receive facilitated tucking position during endotracheal suctioning exhibit more stable behavioral responses than those who do not.

Study Overview

• Status: Completed
• Conditions: Respiratory Distress Syndrome
• Intervention / Treatment: Procedure: tucking position during endotracheal suctioning

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Kafr el-Sheikh
    • Kafr Ash Shaykh, Kafr el-Sheikh, Egypt, 33516
      • Kafrelsheikh University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Gestational age between 32 and 36 weeks, weight 1200 grams or greater.
• Postnatal age: two days after delivery to allow for resolution of analgesia or anesthesia received by their mothers during labor.
• Have endotracheal intubation.

Exclusion Criteria:

• Preterm neonates who have congenital anomalies or neurological malformations, intracranial hemorrhage, seizures.
• Preterm neonates who received sedatives within four hours before the intervention
• Preterm neonates who exposed to any uncomfortable procedure for at least 30 minutes prior to the intervention.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Study Group; Consisted of 20 neonates who will receive tucking position during endotracheal suctioning	Procedure: tucking position during endotracheal suctioning; , the staff nurse will perform the endotracheal suctioning while the researcher will carried out the intervention
No Intervention: Control group; Consisted of 20 neonates who will receive routine care during Endotracheal suctioning

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline of heart rate of preterm neonates on Neonates' Physiological Assessment Tool during and immediately following the endotracheal suction procedure	Neonates' Physiological Assessment Tool was developed by researchers after a review of relevant literature to assess Physiological Parameters of preterm neonates as Heart Rate (HR)	during procedural and immediately after procedure
Change from baseline of Respiratory Rate of preterm neonates on Neonates' Physiological Assessment Tool during and immediately following the endotracheal suction procedure	Neonates' Physiological Assessment Tool was developed by researchers after a review of relevant literature to assess Physiological Parameters of preterm neonates as Respiratory Rate (RR)	during procedural and immediately after procedure
Change from baseline of oxygen saturation in blood of preterm neonates on Neonates' Physiological Assessment Tool during and immediately following the endotracheal suction procedure	Neonates' Physiological Assessment Tool was developed by researchers after a review of relevant literature to assess Physiological Parameters of preterm neonates as oxygen saturation in blood(SPO2)	during procedural and immediately after procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change of baseline of Neonates' behavioral states on Anderson Behavioral State Scale during and immediately following the endotracheal suction procedure	This scale was adopted from Anderson et al.(1990) to assess the behavioral organization of preterm neonates. Neonates' behavioral states are assessed by observing their respiratory regularity, opening or closing of the eyes, limb and trunk activity, and the intensity of crying. Based on the observations, the scale will differentiate 12 behavioral states, including; regular quiet sleep (1), irregular quiet sleep (2), active sleep (3), very active sleep (4), drowsy (5), alert inactivity (6), quite awake (7), active awake (8), very active awake (9), fussing (10), crying (11) and hard crying (12). Scores from 1 to 5 indicate that the neonate is sleeping. Scores from 6 to 8 indicate that the neonate is awake and calm. Scores from 9 to 12 indicate that the neonate is in a state of restless activity or fussiness, which takes substantial energy	during procedural and immediately after procedure

Collaborators and Investigators

• Sponsor: Kafrelsheikh University

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2022
• Primary Completion (Actual): May 1, 2023
• Study Completion (Actual): July 30, 2023

Study Registration Dates

• First Submitted: May 14, 2024
• First Submitted That Met QC Criteria: May 22, 2024
• First Posted (Actual): May 24, 2024

Study Record Updates

• Last Update Posted (Actual): May 24, 2024
• Last Update Submitted That Met QC Criteria: May 22, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Physiological measurement; Endotracheal Suctioning; Behavioral Responses of the Preterm Neonates; Facilitated Tucking Position
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Infant, Newborn, Diseases; Infant, Premature, Diseases; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn
• Other Study ID Numbers: KafrelsheikhU2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No