Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06654115
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
None
First Post:
2024-10-21
Brief Title:
Wireless Physiologic Monitoring After Cesarean
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Wireless Vital Sign Monitoring in Women After Cesarean Birth in Pakistan
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
WIP
Brief Summary:
With over 185 million procedures performed worldwide and increasing Cesarean section CS is the commonest surgical procedure Inpatient monitoring is typically intense due to high risk for hemorrhage and other complications in the immediate post-operative period Vital signs including heart rate blood pressure saturation and temperature are monitored every 10-15 minutes Maintaining this level of monitoring requires a significant dedication of human resources which is unattainable in resource-limited settings RLS Advancements in wireless physiologic monitoring offer a novel strategy to improve current monitoring levels Through our project we will evaluate the clinical use of a wireless physiological monitoring system for immediate postpartum monitoring in women after CS
Our primary aims are
I To explore the clinical adequacy of wireless physiologic monitoring vs standard of care SOC monitoring immediately after uncomplicated Cesarean section in a RLS II To explore the usability of wireless physiologic monitoring vs SOC monitoring among healthcare staff in a RLS
Our primary aims are
I To explore the clinical adequacy of wireless physiologic monitoring vs standard of care SOC monitoring immediately after uncomplicated Cesarean section in a RLS II To explore the usability of wireless physiologic monitoring vs SOC monitoring among healthcare staff in a RLS
Detailed Description:
Basic study design
This pilot study will take place at Sir Ganga Ram Hospital Lahore Pakistan as a cluster randomized clinical trial Pakistan is a developing country with limited resources and a high maternal mortality rate of 189100000 live births The tertiary hospital is located in the heart of historic city of Lahore which has a population of 11 million and the hospital has approximately 24000 births per year A conservative estimate of approximately 30 CS occur each day at the hospital
Intervention
Units will be randomized to the intervention use of wireless physiologic monitoring system WIP or to SOC The WIP system will be provided by YHE BP Doctor Pro Blood Pressure Smartwatch which is a commericially available device The device can monitor heart rate
Randomization
The hospital has 4 units and 1 operative theatre with post-operative ward Each unit is responsible for all incoming operative cases on a rotating 11 randomization within each unit was not selected as there was a risk for contamination within each unit if healthcare staff realized that we were observing vital sign monitoring routines in the SOC arm
Study population
Peripartum women undergoing Cesarean birth The target population is restricted to women undergoing CS due to the higher rates of morbidity and mortality compared to vaginal delivery
Covariates
We will extract relevant patient characteristics such as age district of origin education level occupation referred from another facility relevant obstetric history parity gestational age at birth antenatal complications reason for CS and medical comorbidities hypertension cardiac pulmonary disease etc using chart review completed with patient history with need to ensure no missing data
Outcome Measures
Aim I primary outcome Composite adequacy score CAS which will be a composite of registered measurements of HR saturation and BP measured during the first 2 hours after birth Each registered vital sign will give 1 point According to SOC heart rate blood pressure respiratory rate saturation and temperature are supposed to be 0 20 40 60 80 100 and 120 mins We will compare the number of measurements displayed using the WIP system to SOC manual registration of vital signs in women participating in the study Aim II primary outcome the system usability scale is a validated 10 question quick and easy survey which will be administered to healthcare staff attending women in the post-operative ward to investigate their views of the usability of the technology 0-100 point scale Higher scores indicate better effectiveness ability of users to complete tasks using the system and the quality of the output of tasks efficiency level of resources consumed in performing tasks and satisfaction subjective feeling
Methodology Aim I Over 4 weeks we will include full-term pregnant women according to standard hospital protocols After informed consent the pregnant women from units participating in the intervention arm will be asked to wear the WIP biosensor for 2 hours directly after their CS Data will automatically be transferred to a central monitormobile app which will allow for tracking of vital signs by healthcare staff which will already have access to the monitorapp Confirmed data transmission to the central monitoring station will be assessed and monitoring will begin automatically HR saturation and BP will be measured every 20 minutes according to the protocol In units in the SOC arm vital signs in patients will be measured by healthcare staff according to standard protocols These vital signs are traditionally monitored by pulse-oximetry for saturation manual wrist palpation for HR and BP monitor-cuff which are entered into patient electronic charts Data from patient charts will be extracted daily
Aim II
After the monitoring session usability will be measured by asking the healthcare staff in both arms of the study to complete a brief questionnaire based on the System Usability Scale This evaluation tool will be administered only to those healthcare staff responsible for post-operative monitoring of women after CS A score of 0-100 will be calculated The scale has been found to be both robust and reliable More specifically healthcare staff will be asked to assess how easy the WIP biosensor was to use and interpret whether they liked interacting with the system whether they would be willing to use it again in the future Similarly questions will be asked for the SOC strategy as well
Data analysis and statistics
Descriptive statistics will be used to summarize participant characteristics obstetric and medical comorbidities We will compare these covariates in the WIP intervention and the SOC arms to elucidate any major differences in the characteristics of the two groups If we find possible confounders and considering that this is a small RCT we will formally consider adjusting for possible confounders in our statistical analyses Outcome variables such as CAS system usability score early breast-feeding and skin-to-skin contact will first be described for both arms using absolute counts and percentages Monitoring with the WIP device will be deemed adequate if there was 94 capture of the maternal HR RR temperature saturation and BP every 20 minutes and if the captured data is successfully transferred to the central monitor for review CAS64 points out of 70 Additionally for CAS main outcome in case of missing data ie if monitoring was stopped before 2 hours data will be assumed to be missing at random and we will use imputation to account for missing values This data will be reported both in the original and after-imputation format We will use linear regression to compare the outcome variables CAS and system usability score continuous variables to our predictor variables WIP intervention vs SOC dichotomous As mentioned earlier in case of differences between the two groups we will adjust the linear regression model accordingly and report both crude and adjusted values Adjusted values will be reported using multiple linear regression Since this is a small RCT we do not anticipate finding any effect modifiers and are therefore not planning to stratify our results
Power analysis
Using the two sample t-test with mean difference in CAS of 2 points standard deviation of 3 two-sided alpha of 005 and a power of 08 the sample size per study arm should be 68 each arm34 We anticipate 20 of women to decline participation and increasing the sample size to 41 women per arm However due to the large number of operations occurring at the hospital we plan to recruit at least 100 patients with 50 patients in each arm of the study
This pilot study will take place at Sir Ganga Ram Hospital Lahore Pakistan as a cluster randomized clinical trial Pakistan is a developing country with limited resources and a high maternal mortality rate of 189100000 live births The tertiary hospital is located in the heart of historic city of Lahore which has a population of 11 million and the hospital has approximately 24000 births per year A conservative estimate of approximately 30 CS occur each day at the hospital
Intervention
Units will be randomized to the intervention use of wireless physiologic monitoring system WIP or to SOC The WIP system will be provided by YHE BP Doctor Pro Blood Pressure Smartwatch which is a commericially available device The device can monitor heart rate
Randomization
The hospital has 4 units and 1 operative theatre with post-operative ward Each unit is responsible for all incoming operative cases on a rotating 11 randomization within each unit was not selected as there was a risk for contamination within each unit if healthcare staff realized that we were observing vital sign monitoring routines in the SOC arm
Study population
Peripartum women undergoing Cesarean birth The target population is restricted to women undergoing CS due to the higher rates of morbidity and mortality compared to vaginal delivery
Covariates
We will extract relevant patient characteristics such as age district of origin education level occupation referred from another facility relevant obstetric history parity gestational age at birth antenatal complications reason for CS and medical comorbidities hypertension cardiac pulmonary disease etc using chart review completed with patient history with need to ensure no missing data
Outcome Measures
Aim I primary outcome Composite adequacy score CAS which will be a composite of registered measurements of HR saturation and BP measured during the first 2 hours after birth Each registered vital sign will give 1 point According to SOC heart rate blood pressure respiratory rate saturation and temperature are supposed to be 0 20 40 60 80 100 and 120 mins We will compare the number of measurements displayed using the WIP system to SOC manual registration of vital signs in women participating in the study Aim II primary outcome the system usability scale is a validated 10 question quick and easy survey which will be administered to healthcare staff attending women in the post-operative ward to investigate their views of the usability of the technology 0-100 point scale Higher scores indicate better effectiveness ability of users to complete tasks using the system and the quality of the output of tasks efficiency level of resources consumed in performing tasks and satisfaction subjective feeling
Methodology Aim I Over 4 weeks we will include full-term pregnant women according to standard hospital protocols After informed consent the pregnant women from units participating in the intervention arm will be asked to wear the WIP biosensor for 2 hours directly after their CS Data will automatically be transferred to a central monitormobile app which will allow for tracking of vital signs by healthcare staff which will already have access to the monitorapp Confirmed data transmission to the central monitoring station will be assessed and monitoring will begin automatically HR saturation and BP will be measured every 20 minutes according to the protocol In units in the SOC arm vital signs in patients will be measured by healthcare staff according to standard protocols These vital signs are traditionally monitored by pulse-oximetry for saturation manual wrist palpation for HR and BP monitor-cuff which are entered into patient electronic charts Data from patient charts will be extracted daily
Aim II
After the monitoring session usability will be measured by asking the healthcare staff in both arms of the study to complete a brief questionnaire based on the System Usability Scale This evaluation tool will be administered only to those healthcare staff responsible for post-operative monitoring of women after CS A score of 0-100 will be calculated The scale has been found to be both robust and reliable More specifically healthcare staff will be asked to assess how easy the WIP biosensor was to use and interpret whether they liked interacting with the system whether they would be willing to use it again in the future Similarly questions will be asked for the SOC strategy as well
Data analysis and statistics
Descriptive statistics will be used to summarize participant characteristics obstetric and medical comorbidities We will compare these covariates in the WIP intervention and the SOC arms to elucidate any major differences in the characteristics of the two groups If we find possible confounders and considering that this is a small RCT we will formally consider adjusting for possible confounders in our statistical analyses Outcome variables such as CAS system usability score early breast-feeding and skin-to-skin contact will first be described for both arms using absolute counts and percentages Monitoring with the WIP device will be deemed adequate if there was 94 capture of the maternal HR RR temperature saturation and BP every 20 minutes and if the captured data is successfully transferred to the central monitor for review CAS64 points out of 70 Additionally for CAS main outcome in case of missing data ie if monitoring was stopped before 2 hours data will be assumed to be missing at random and we will use imputation to account for missing values This data will be reported both in the original and after-imputation format We will use linear regression to compare the outcome variables CAS and system usability score continuous variables to our predictor variables WIP intervention vs SOC dichotomous As mentioned earlier in case of differences between the two groups we will adjust the linear regression model accordingly and report both crude and adjusted values Adjusted values will be reported using multiple linear regression Since this is a small RCT we do not anticipate finding any effect modifiers and are therefore not planning to stratify our results
Power analysis
Using the two sample t-test with mean difference in CAS of 2 points standard deviation of 3 two-sided alpha of 005 and a power of 08 the sample size per study arm should be 68 each arm34 We anticipate 20 of women to decline participation and increasing the sample size to 41 women per arm However due to the large number of operations occurring at the hospital we plan to recruit at least 100 patients with 50 patients in each arm of the study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None