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

Care Clinical Trial

Official title:

The Effect Of The Care Package Applıed To Babıes Whıch Are Monıtored Wıth Temporary Follow-Up Of The Newborn In The Newborn Intensıve Care Unıt On The Duratıon Of Stay In Non-Invasıve Mechanıcal Ventılatıon And Physıologıcal Parameters

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06189989
• Other study ID #: OkanÜniversitesiEsmaSeker001
• Status: Completed
• Phase: N/A
• Start date: January 30, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: December 2023
• Source: Okan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

This study was carried out as a semi-experimental 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 of Istanbul Esenler Gynecology and Children's Hospital, on the duration of stay in noninvasive mechanical ventilation and physiological parameters.

Hypothesis 1 (H1): The care package applied to babies monitored with transient tachypnea of the newborn shortens the duration of stay in noninvasive mechanical ventilation.

Hypothesis 2 (H2): The care package applied to babies monitored with transient tachypnea of the newborn positively affects physiological parameters.

Hypothesis 3 (H3): The care package applied to babies monitored with transient tachypnea of the newborn positively affects blood gas parameters.

The research was conducted in the Neonatal Intensive Care Unit of Esenler Gynecology and Children's Hospital between January 2023 and October 2023.

The sample size was determined by power analysis. The power of the sample in the research was calculated with the G*Power 3.1 program. While the type I error amount was 0.05, the power of the test = 0.85 (α=0.05, 1-β=0.84, effect size: 0.7), the minimal sample size was calculated as 60 newborns (30 newborns in each group). 40 newborns were included in the study. The study was completed by including 40 newborns in the neonatal intervention group (the group in which temporary tachypnea of the newborn care package was applied) and 40 newborns in the control group.

Sample selection criteria; of the newborn;

• 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

Exclusion criteria from the sample;

• 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.

The "Data Collection and Daily Monitoring Form", in which some descriptive characteristics of the baby and physiological parameter measurements were evaluated, was used as a data collection tool. In addition, necessary devices (monitor and sphygmomanometer, stopwatch, thermometer, blood gas device) were used to control physiological parameters.

Care Package for Transient Tachypnea (TTN) Current literature was scanned while determining the parameters included in the care package applied in case of temporary tachypnea of the newborn. Expert opinion was taken for the content of the care package prepared in line with the literature (2 academic nurses, 2 clinical nurses and 1 specialist physician). Care Package consists of 5 items.

1. Heating and humidifying the oxygen-air mixture given to the baby

2. Stopping the baby's feeding and switching to open drainage with orogastric tube (OGS)

3. Application of postural drainage, percussion and vibration 4 times a day for an average of 10-15 minutes

4. If necessary, aspirate the baby

5. Changing the position given to the baby (to increase oxygenation) periodically (every 3 hours)

The newborns included in the study were divided into two groups: intervention and control groups. Between the dates of the research, the first 40 newborns who met the sampling criteria were included in the control group (who received nursing care in line with the routine care protocol of the clinic), and the 40 newborns who met the sample criteria (who received nursing care in line with the routine care protocol of the clinic) were included in the control group, and the 40 newborns who met the sample criteria were given training on the care package after the nurses working in the clinic. (in addition to the maintenance package application) were included in the intervention group.

To prevent the research groups from being influenced by each other, the study started with the control group first. Nursing care was applied to the control group in line with the routine care protocol of the clinic. After the control group data were collected, all nurses working in the clinic were given training on the application of the neonatal temporary tachypnea care package to be applied to the intervention group. The training was given within the scope of a presentation prepared by the researcher in the staff room within the clinic. The training was planned according to the nurses' working hours and was planned in 5 separate groups according to the day they were in the hospital and their available hours. The training lasted approximately 20 minutes. After the training was completed, care package applications for the intervention group started.

A data collection and daily monitoring form was filled out for newborns in both groups immediately after admission to the intensive care unit. The newborn was placed in a pre-heated incubator and monitored. A hydrocolloid strip tape was cut and pasted in a T shape on his nose and he was connected to the mechanical ventilator via a ram cannula interface. An oragastric catheter was inserted into the stomach (with a 10ml syringe) and open drainage was performed. Blood samples requested by the physician were taken and a vascular access was established. The patient's intravenous fluid was started. After the newborn was stabilized, care practices were performed every three hours in line with the clinical routine care protocol. Neonatal temporary tachypnea care package was applied to the newborns in the intervention group in addition to the clinical routine until they were weaned from mechanical ventilation support.

Evaluation of Data The data were evaluated with appropriate statistical analysis in the SPSS 21.0 program. Number, percentage, mean and standard deviation were used as descriptive statistical methods in the evaluation of the data. Frequency and percentage distributions of the data are given. In the study, intra-group measurements were made with correlated sample one-way analysis of variance, and inter-group measurements were made with independent group t test. Bonferonni test was applied to determine which group caused the difference. 0.05 was used as the significance level, and if p<0.05 it was stated that there was a significant difference, and if p>0.05 it was stated that there was no significant difference.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: December 31, 2023
• Est. primary completion date: October 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 36 Weeks to 41 Weeks

Eligibility

Inclusion Criteria:

-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

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Care

Intervention

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

Locations

Country	Name	City	State
Turkey	Esma Seker	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Okan University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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	Total duration of mechanical ventilation stay	in total hours	1 hour after discharge from intensive care
Secondary	Total duration of stay in intensive care unit duration of transition to oral feeding were evaluated).	in total hours	1 hour after discharge from intensive care
Secondary	Total duration of transition to oral feeding were	in total hours	1 hour after discharge from intensive care