CareNCT06189989
Effect of Care Package on Duration of Stay and Physiological Parameters in Non-invasive Mechanical Ventilation
A study testing The group to which a care package was applied in addition to the clinical routine care protocol) in people with Care, run by Okan University at 1 site in Turkey (Türkiye).
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… Read more about this study
- Who is it for?
- Ages 36 to 41 weeksHealthy volunteers can take part
- Conditions the study is for
- Care
- What is being tested?
- The group to which a care package was applied in addition to the clinical routine care protocol)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Jan 2022to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 36 to 41 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- -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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read more
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.
Read the 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 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.
- Heating and humidifying the oxygen-air mixture given to the baby
- Stopping the baby's feeding and switching to open drainage with orogastric tube (OGS)
- Application of postural drainage, percussion and vibration 4 times a day for an average of 10-15 minutes
- If necessary, aspirate the baby
- 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.
- Conditions
- Care
- Being tested
- The group to which a care package was applied in addition to the clinical routine care protocol)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The group to which a care package was applied in addition to the clinical routine care protocol)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart rate Vital Signs
Heart rate (beats/minute) were evaluated
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
in total hours
Measured: 1 hour after discharge from intensive care
Total duration of stay in intensive care unit duration of transition to oral feeding were evaluated).
in total hours
Measured: 1 hour after discharge from intensive care
Total duration of transition to oral feeding were
in total hours
Measured: 1 hour after discharge from intensive care
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2024
- Study start30 Jan 2022
- Primary completion30 Oct 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CareStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- control grup and intervention grup
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Okan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esma Şeker, Okan University
- Investigators
- Gülzade Uysal, Assoc. Dr, Study director, Okan Üniversitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06189989
- Sponsor's protocol ID
- OkanÜniversitesiEsmaŞeker001
- Status last verified
- Dec 2023
- First submitted
- 9 Dec 2023
- Last updated
- 5 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06189989
- Acronym / sponsor ID
- OkanÜniversitesiEsmaŞeker001
- Conditions
- Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Okan UniversityUniversity, hospital or other
- Study start
- 30 Jan 2022 (actual)
- Primary completion
- 30 Oct 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 5 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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.
- Heating and humidifying the oxygen-air mixture given to the baby
- Stopping the baby's feeding and switching to open drainage with orogastric tube (OGS)
- Application of postural drainage, percussion and vibration 4 times a day for an average of 10-15 minutes
- If necessary, aspirate the baby
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- control grup and intervention grup
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: The group to which a care package was applied in addition to the clinical routine care protocol)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. |
| 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. |
Who may qualify
- Ages
- 36 to 41 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- -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
Key exclusion criteria (6 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Intervention Group |
Primary outcome
Heart rate Vital Signs
Time frame: 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.
Heart rate (beats/minute) were evaluated
Respiratory Rate Vital Signs
Time frame: 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 (breaths/minute) were evaluated
Body temperature Vital Signs
Time frame: 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 (°C) were evaluated
Oxygen saturation Vital Signs
Time frame: 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 (%) were evaluated
Blood pressure Vital Signs
Time frame: 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 (mmHg) were evaluated
blood gas pH value :
Time frame: 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 H iyon
blood gas PCO2 value
Time frame: 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 (mmHg) were evaluted
blood gas HCO3 value
Time frame: 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 (mEq/L) were evaluted
blood gas PaO2 value
Time frame: 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 (mmHg)were evaluted
blood gas SaO2 value :
Time frame: 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 (mmHg)were evaluted
blood gas lactat value
Time frame: 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 (mmol/L) were evaluted
blood gas BE value
Time frame: 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(mmol/L) were evaluted
3 secondary outcomes
Total duration of mechanical ventilation stay
Time frame: 1 hour after discharge from intensive care
Total duration of stay in intensive care unit duration of transition to oral feeding were evaluated).
Time frame: 1 hour after discharge from intensive care
Total duration of transition to oral feeding were
Time frame: 1 hour after discharge from intensive care
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gülzade Uysal, Assoc. Dr study director
Okan Üniversitesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The group to which a care package was applied in addition to the clinical routine care protocol) in people with Care, run by Okan University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart rate Vital Signs (time frame: 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.). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2024.