Effect of Care Package on Duration of Stay and Physiological Parameters in Non-invasive Mechanical Ventilation

NCT06189989 | Completed

• 1 other identifier: OkanÜniversitesiEsmaŞeker001
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Temporary tachypnea of the newborn can be improved with minimal respiratory support and nursing care given to babies within the first 72 hours of life. Nursing care practices; It includes pain management, aspiration, moistening and warming of the airways, skin care, nutrition, body temperature regulation, positioning and chest physiotherapy practices. Physiotherapy practices, when applied in accordance with the criteria, can reduce the newborn's respiratory problems and shorten the hospital stay. Although it has been reported that chest physiotherapy practices have a clinically positive effect on newborns, studies in this field are insufficient. Nowadays, the concept of care package is frequently used, especially in areas where nursing care is very important, such as intensive care. Implementation of care packages in patient care increases the quality of care by ensuring standardization in the clinic. It also contributes to observing improvements in health practices. The positive results of the use of care packages in their application areas and the lack of care package application in babies monitored with temporary tachypnea of the newborn when the literature was scanned have led to the necessity of conducting studies in this field. The study was planned as a semi-experimental (non-randomized) control group study to examine the effect of the care package applied to babies monitored with temporary tachypnea of the newborn in the neonatal intensive care unit on the duration of stay in noninvasive mechanical ventilation and physiological parameters.

Conditions

Care

Outcome Measures

Primary Outcomes (12)

• Heart rate Vital Signs

  Heart rate (beats/minute) were evaluated

  It was evaluated upon admission to intensive care, 1 hour after the first care, and 1 hour after the first care after weaning from mechanical ventilation.

• Respiratory Rate Vital Signs

  Respiratory Rate (breaths/minute) were evaluated

  It was evaluated upon admission to intensive care, 1 hour after the first care, and 1 hour after the first care after weaning from mechanical ventilation.

• Body temperature Vital Signs

  Body temperature (°C) were evaluated

  It was evaluated upon admission to intensive care, 1 hour after the first care, and 1 hour after the first care after weaning from mechanical ventilation.

• Oxygen saturation Vital Signs

  Oxygen saturation (%) were evaluated

  It was evaluated upon admission to intensive care, 1 hour after the first care, and 1 hour after the first care after weaning from mechanical ventilation.

• Blood pressure Vital Signs

  Blood pressure (mmHg) were evaluated

  It was evaluated upon admission to intensive care, 1 hour after the first care, and 1 hour after the first care after weaning from mechanical ventilation.

• blood gas pH value :

  blood gas H iyon

  It was evaluated upon admission to the intensive care unit, immediately before weaning from mechanical ventilation, and 1 hour after weaning from mechanical ventilation.

• blood gas PCO2 value

  blood gas PCO2 (mmHg) were evaluted

  It was evaluated upon admission to the intensive care unit, immediately before weaning from mechanical ventilation, and 1 hour after weaning from mechanical ventilation.

• blood gas HCO3 value

  blood gas HCO3 (mEq/L) were evaluted

  It was evaluated upon admission to the intensive care unit, immediately before weaning from mechanical ventilation, and 1 hour after weaning from mechanical ventilation.

• blood gas PaO2 value

  blood gas PaO2 (mmHg)were evaluted

  It was evaluated upon admission to the intensive care unit, immediately before weaning from mechanical ventilation, and 1 hour after weaning from mechanical ventilation.

• blood gas SaO2 value :

  blood gas SaO2 (mmHg)were evaluted

  It was evaluated upon admission to the intensive care unit, immediately before weaning from mechanical ventilation, and 1 hour after weaning from mechanical ventilation.

• blood gas lactat value

  blood gas lactat (mmol/L) were evaluted

  It was evaluated upon admission to the intensive care unit, immediately before weaning from mechanical ventilation, and 1 hour after weaning from mechanical ventilation.

• blood gas BE value

  blood gas BE(mmol/L) were evaluted

  It was evaluated upon admission to the intensive care unit, immediately before weaning from mechanical ventilation, and 1 hour after weaning from mechanical ventilation.

Secondary Outcomes (3)

• Total duration of mechanical ventilation stay

  1 hour after discharge from intensive care

• Total duration of stay in intensive care unit duration of transition to oral feeding were evaluated).

  1 hour after discharge from intensive care

• Total duration of transition to oral feeding were

  1 hour after discharge from intensive care

Study Arms (2)

Intervention Group

EXPERIMENTAL

In addition to the clinical routine care, the newborn temporary tachypnea care package that we created was applied to the babies in the intervention group. Physiological parameters and blood gas results were recorded.

Behavioral: The group to which a care package was applied in addition to the clinical routine care protocol)

Control group

NO INTERVENTION

Only clinical routine care practices were applied to the babies in the control group. Physiological parameters and blood gas results were recorded.

Interventions

The group to which a care package was applied in addition to the clinical routine care protocol) BEHAVIORAL

Intervention Group: * Immediately after the newborn's admission to the intensive care unit, mechanical ventilation mode, physiological parameters, blood gas results and descriptive characteristics of the baby were recorded in the "Data Collection and Daily Monitoring Form". * In addition to the routine care practices of the clinic (every 3 hours / 8 times a day), the newborn's temporary tachypnea care package was applied. Postural drainage, percussion and vibration were applied 4 times a day for an average of 10-15 minutes. * Mechanical ventilation mode and physiological parameters were recorded one hour after 4 daily maintenance applications. * Blood gas parameters were evaluated immediately before and 1 hour after the newborn was separated from mechanical ventilation. * Physiological parameters were recorded again 1 hour after the first routine nursing care after the newborn was separated from mechanical ventilation.

Intervention Group

Eligibility Criteria

• Age: 36 Weeks - 41 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Being 36 weeks or above according to gestational age
• Birth weight being 1500 grams and above
• Receive noninvasive mechanical ventilation support
• Feeding via orogastric tube
• Parents' consent for the baby to be included in the study

You may not qualify if:

• Those with pneumothorax and suspicion
• Those with cranial bleeding or any suspicion of bleeding
• Babies with congenital anomalies affecting breathing
• Babies who are reconnected to mechanical ventilation after being weaned off noninvasive mechanical ventilation
• Babies with neurological diseases (no neurological problems (hypotonia, hypertonic etc.), no history of convulsions, not using sedative drugs, normal cranial USG,
• Babies with any fractures (clavicle, femur, etc.) were excluded from the sample.

Sponsors & Collaborators

• Okan University: lead

Study Sites (1)

Esma Şeker

Istanbul, 34230, Turkey (Türkiye)

Location

Study Officials

• Gülzade Uysal, Assoc. Dr

  Okan Üniversitesi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Esma Şeker

Model Details: control grup and intervention grup

Study Record Dates

• First Submitted: December 9, 2023
• First Posted: January 5, 2024
• Study Start: January 30, 2022
• Primary Completion: October 30, 2023
• Study Completion: December 31, 2023
• Last Updated: January 5, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)