Ignite Creation Date:
2024-05-06 @ 7:55 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06189989
Status:
COMPLETED
Last Update Posted:
2024-01-05
First Post:
2023-12-09
Brief Title:
Effect of Care Package on Duration of Stay and Physiological Parameters in Non-invasive Mechanical Ventilation
Sponsor:
Okan University
Organization:
Okan University
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 newborns 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
Physiotherapy practices when applied in accordance with the criteria can reduce the newborns 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
Detailed 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 Childrens 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 Childrens 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 GPower 31 program While the type I error amount was 005 the power of the test 085 α005 1-β084 effect size 07 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 babys 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 patients 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 210 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 005 was used as the significance level and if p005 it was stated that there was a significant difference and if p005 it was stated that there was no significant difference
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 Childrens 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 GPower 31 program While the type I error amount was 005 the power of the test 085 α005 1-β084 effect size 07 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 babys 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 patients 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 210 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 005 was used as the significance level and if p005 it was stated that there was a significant difference and if p005 it was stated that there was no significant difference
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None