Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06549283
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-08-08
Brief Title:
Nasal Intermittent Positive Pressure Ventilation During Neonatal Intubation
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Nasal Intermittent Positive Pressure Ventilation NIPPV During Neonatal Endotracheal Intubation A Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2024-08
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:
None
Brief Summary:
The study aims to determine whether the use of nasal intermittent positive pressure ventilation NIPPV during neonatal endotracheal intubation increases the rate of successful intubation without physiological instability during all intubation attempts
The present study was designed as a prospective multicenter randomized controlled study conducted with neonates undergoing endotracheal intubation The infants were assigned randomly to either the NIPPV group or the standard care group
The present study was designed as a prospective multicenter randomized controlled study conducted with neonates undergoing endotracheal intubation The infants were assigned randomly to either the NIPPV group or the standard care group
Detailed Description:
The present study was designed as a prospective multicenter randomized controlled trial The study was conducted at two tertiary Neonatal Intensive Care Units Mugla Training and Research Hospital Mugla Turkey Akdeniz University School of Medicine Antalya Turkey between May 2023 and May 2024 Written informed consent was obtained from the parents of each neonatal patient prior to enrollment in the study
Participants
Infants of a gestational age of 22-41 weeks and undergoing oral endotracheal intubation in the neonatal intensive care unit within the first 28 days of life were eligible for inclusion in the present study The infants who required urgent intubation those intubated in the delivery room or the operating room infants with a heart rate of 120min prior to randomization those with airway or lung anomalies the ones with cyanotic congenital heart disease and the ones for whom nasal intermittent positive pressure ventilation NIPPV treatment was contraindicated congenital nasal anomaly congenital diaphragmatic hernia or abdominal wall defect were excluded from the study
Randomization
Each infant was randomly assigned to either the intervention group or the standard-care group Sequential numbers were generated in the neonatal intensive care units computer with an allocation ratio of 11 The numbers were concealed in opaque sequentially numbered sealed envelopes The physician on call opened sequentially numbered sealed opaque envelopes and randomized infants to respective groups before procedure
Definitions
An attempt was defined as an airway maneuver which commenced with the insertion of the laryngoscope blade conventional into the mouth of the patient and ended with the removal of the blade Successful airway management was defined as the placement of an endotracheal tube in the trachea confirmed based on chest elevation auscultation second independent laryngoscopy carbon dioxide detection andor chest radiography First-attempt success was defined as successful intubation by the first practitioner on the first attempt Multiple-attempt success was defined as the requirement of over two attempts 3 for successful intubation The requirement for single two or multiple attempts for successful intubation was defined as all intubation attempts Severe oxygen desaturation during intubation was defined as a decrease of 20 in oxygen saturation relative to the highest level of oxygen saturation recorded prior to the first attempt Bradycardia was defined as a heart rate of 100 beats per minute Physiological instability was defined as severe desaturation a decrease of 20 in oxygen saturation relative to that immediately prior to pre-laryngoscopy or bradycardia a heart rate of 100 beats per minute during the intubation attempts
Interventions
All neonates were monitored using a Philips monitor IntelliVue MX450 that displayed the real-time peripheral oxygen saturation SpO2 and heart rate prior to during and after the procedure The patients were divided into two groups the NIPPV group and the standard care group In the NIPPV group NIPPV was implemented during the entire intubation process pre-intubation to intubation to the end of successful intubation Appropriately-sized bi-nasal cannulae Optiflow Junior Fisher and Paykel Auckland New Zealand were placed prior to laryngoscopy as interface for NIPPV implementation NIPPV was implemented using Drager Babylog 8000 Draeger Medicals Inc Lubeck Germany or Leoni Plus Löwenstein Medical Bad Ems Germany mechanical ventilator Non-synchronized NIPPV was implemented NIPPV was initiated prior to intubation with the peak inspiratory pressure set to 16-20 cmH2O selected according to the infants birth weight and chest wall expansion positive-end expiratory pressure set to 6 cmH2O breathing rate set to 40-50 breathsmin inspiratory time set to 040-045 s and flow rate set to 8-12 Lmin After the first successful intubation attempt NIPPV was discontinued Prior to laryngoscopy the fraction of inspired oxygen FiO2 was adjusted to maintain SpO2 above 90 In the standard care group the intubation attempt proceeded without NIPPV or supplemental oxygen In the event of failure in the intubation attempt SpO2 was increased above 90 and the heart rate was increased above 120min by applying positive pressure ventilation using a face mask prior to initiating the next intubation procedure The size of the intubation tube was determined based on the babys body weight 12 Stylet was not used during intubation Endotracheal intubations were performed either by pediatric research assistants or a neonatologist A conventional laryngoscope with a straight blade was used for the intubation Video laryngoscope was not used Data accuracy was ensured by videotaping the monitor-displayed heart rate and SpO2 during the intubation procedure After intubation an independent assessor who was not part of the intubation team reviewed all recorded videos to document the obtained data on a case report form
Data collection and management
Data for demographic and clinical characteristics were collected for all patients A pre-assigned staff member who was not a part of the intubation team noted the vital signs adverse outcomes and complications during and after the procedure and also collected blood gas one hour after the intubation for each patient
Trial outcomes
The primary outcome was successful intubation without physiological instability during all intubation attempts in the neonate The secondary outcome was the lowest SpO2 level lowest heart rate bradycardia severe desaturation duration of severe desaturation successful intubation on the first attempt without physiological instability and time to successful intubation
Sample size
Hodgson et al reported that the rate of successful intubation on the first attempt without physiological instability was 31 in newborns who did not receive additional respiratory support during intubation In the present study it was hypothesized that the success rate of intubation on the first attempt without physiological instability would increase from 31 to 54 upon the implementation of NIPPV during intubation The sample size was calculated using the GPower 3194 program with a type I error of 5 level and a power of 80 Accordingly it was concluded that 75 intubation episodes were required for each group and 150 intubation episodes were required in total
Statistical analysis
Statistical analysis was performed using Statistical Package for the Social Sciences SPSS software version 25 Armonk NY IBM Corp The Kolmogorov-Smirnov and Shapiro-Wilk tests were conducted to determine the normal distribution of data Students t-test was conducted to compare the continuous parametric variables The Mann-Whitney U-test was conducted to compare variables with non-normal distribution Chi-squared or Fishers exact test was conducted to analyze the categorical variables Categorical variables were expressed as numbers Normally distributed variables were expressed as mean standard deviation values Non-parametric continuous variables were expressed as median values interquartile range The difference with p 005 was considered statistically significant
Participants
Infants of a gestational age of 22-41 weeks and undergoing oral endotracheal intubation in the neonatal intensive care unit within the first 28 days of life were eligible for inclusion in the present study The infants who required urgent intubation those intubated in the delivery room or the operating room infants with a heart rate of 120min prior to randomization those with airway or lung anomalies the ones with cyanotic congenital heart disease and the ones for whom nasal intermittent positive pressure ventilation NIPPV treatment was contraindicated congenital nasal anomaly congenital diaphragmatic hernia or abdominal wall defect were excluded from the study
Randomization
Each infant was randomly assigned to either the intervention group or the standard-care group Sequential numbers were generated in the neonatal intensive care units computer with an allocation ratio of 11 The numbers were concealed in opaque sequentially numbered sealed envelopes The physician on call opened sequentially numbered sealed opaque envelopes and randomized infants to respective groups before procedure
Definitions
An attempt was defined as an airway maneuver which commenced with the insertion of the laryngoscope blade conventional into the mouth of the patient and ended with the removal of the blade Successful airway management was defined as the placement of an endotracheal tube in the trachea confirmed based on chest elevation auscultation second independent laryngoscopy carbon dioxide detection andor chest radiography First-attempt success was defined as successful intubation by the first practitioner on the first attempt Multiple-attempt success was defined as the requirement of over two attempts 3 for successful intubation The requirement for single two or multiple attempts for successful intubation was defined as all intubation attempts Severe oxygen desaturation during intubation was defined as a decrease of 20 in oxygen saturation relative to the highest level of oxygen saturation recorded prior to the first attempt Bradycardia was defined as a heart rate of 100 beats per minute Physiological instability was defined as severe desaturation a decrease of 20 in oxygen saturation relative to that immediately prior to pre-laryngoscopy or bradycardia a heart rate of 100 beats per minute during the intubation attempts
Interventions
All neonates were monitored using a Philips monitor IntelliVue MX450 that displayed the real-time peripheral oxygen saturation SpO2 and heart rate prior to during and after the procedure The patients were divided into two groups the NIPPV group and the standard care group In the NIPPV group NIPPV was implemented during the entire intubation process pre-intubation to intubation to the end of successful intubation Appropriately-sized bi-nasal cannulae Optiflow Junior Fisher and Paykel Auckland New Zealand were placed prior to laryngoscopy as interface for NIPPV implementation NIPPV was implemented using Drager Babylog 8000 Draeger Medicals Inc Lubeck Germany or Leoni Plus Löwenstein Medical Bad Ems Germany mechanical ventilator Non-synchronized NIPPV was implemented NIPPV was initiated prior to intubation with the peak inspiratory pressure set to 16-20 cmH2O selected according to the infants birth weight and chest wall expansion positive-end expiratory pressure set to 6 cmH2O breathing rate set to 40-50 breathsmin inspiratory time set to 040-045 s and flow rate set to 8-12 Lmin After the first successful intubation attempt NIPPV was discontinued Prior to laryngoscopy the fraction of inspired oxygen FiO2 was adjusted to maintain SpO2 above 90 In the standard care group the intubation attempt proceeded without NIPPV or supplemental oxygen In the event of failure in the intubation attempt SpO2 was increased above 90 and the heart rate was increased above 120min by applying positive pressure ventilation using a face mask prior to initiating the next intubation procedure The size of the intubation tube was determined based on the babys body weight 12 Stylet was not used during intubation Endotracheal intubations were performed either by pediatric research assistants or a neonatologist A conventional laryngoscope with a straight blade was used for the intubation Video laryngoscope was not used Data accuracy was ensured by videotaping the monitor-displayed heart rate and SpO2 during the intubation procedure After intubation an independent assessor who was not part of the intubation team reviewed all recorded videos to document the obtained data on a case report form
Data collection and management
Data for demographic and clinical characteristics were collected for all patients A pre-assigned staff member who was not a part of the intubation team noted the vital signs adverse outcomes and complications during and after the procedure and also collected blood gas one hour after the intubation for each patient
Trial outcomes
The primary outcome was successful intubation without physiological instability during all intubation attempts in the neonate The secondary outcome was the lowest SpO2 level lowest heart rate bradycardia severe desaturation duration of severe desaturation successful intubation on the first attempt without physiological instability and time to successful intubation
Sample size
Hodgson et al reported that the rate of successful intubation on the first attempt without physiological instability was 31 in newborns who did not receive additional respiratory support during intubation In the present study it was hypothesized that the success rate of intubation on the first attempt without physiological instability would increase from 31 to 54 upon the implementation of NIPPV during intubation The sample size was calculated using the GPower 3194 program with a type I error of 5 level and a power of 80 Accordingly it was concluded that 75 intubation episodes were required for each group and 150 intubation episodes were required in total
Statistical analysis
Statistical analysis was performed using Statistical Package for the Social Sciences SPSS software version 25 Armonk NY IBM Corp The Kolmogorov-Smirnov and Shapiro-Wilk tests were conducted to determine the normal distribution of data Students t-test was conducted to compare the continuous parametric variables The Mann-Whitney U-test was conducted to compare variables with non-normal distribution Chi-squared or Fishers exact test was conducted to analyze the categorical variables Categorical variables were expressed as numbers Normally distributed variables were expressed as mean standard deviation values Non-parametric continuous variables were expressed as median values interquartile range The difference with p 005 was considered statistically significant
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