Ignite Creation Date:
2024-05-11 @ 8:31 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06404294
Status:
RECRUITING
Last Update Posted:
2024-05-08
First Post:
2024-04-02
Brief Title:
The External Diaphragm Pacemaker Assisted Extubation in Premature Infants With Invasive Mechanical Ventilation
Sponsor:
Childrens Hospital of Chongqing Medical University
Organization:
Childrens Hospital of Chongqing Medical University
Study Overview
Official Title:
A Randomized Controlled Study of the External Diaphragm Pacemaker Assisted Extubation in Premature Infants With Invasive Mechanical Ventilation
Status:
RECRUITING
Status Verified Date:
2024-05
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:
With the development of perinatal medicine more and more newborns with respiratory failure can be treated due to the use of respiratory support technology However long-term invasive mechanical ventilation treatment can lead to a series of complications such as ventilator-associated pneumonia atelectasis and air leakage syndrome and increase the risk of bronchopulmonary dysplasia and neurodevelopmental lag of premature infants It also leads to longer hospital stays and higher hospital costs To shorten the invasive mechanical ventilation time and improve the success rate of withdrawal through various ways is the development direction of neonatal mechanical ventilation therapy
Respiratory muscle atrophy is common and rapid in children receiving invasive mechanical ventilation and is an important cause of ventilator dependence and withdrawal failure The diaphragm of newborns is the main respiratory muscle of which the diaphragm type 1 endurance fiber accounts for only about 30 far lower than the proportion of about 55 in adults so the diaphragm of newborns is more prone to fatigue Previous animal experiments and clinical studies in children and adults have confirmed that diaphragmatic pacing therapy applied to patients with long-term invasive mechanical ventilation can prevent diaphragmatic atrophy reverse diaphragmatic injury significantly improve diaphragmatic thickness improve diaphragmatic anti-fatigue ability thereby increasing lung ventilation relieving dyspnea and achieving the effect of assisted extubation
The neonatology Department of the Childrens Hospital Affiliated to Chongqing Medical University started neonatal external diaphragm pacemaker treatment in 2022 and has completed 1383 cases so far initially showing the effectiveness and safety of external diaphragm pacemaker treatment in neonatal population But so far there is no systematic evaluation of clinical intervention effect of external diaphragm pacemaker treatment on neonatal respiratory failure patients at home and abroad Based on this the project team intends to conduct a prospective randomized controlled study to systematically evaluate the safety of external diaphragm pacemaker in preterm infants requiring invasive mechanical ventilation for 7 days at 28 to 35 weeks of gestation and to evaluate the efficacy of external diaphragm pacemaker in adjuvant extubation
Respiratory muscle atrophy is common and rapid in children receiving invasive mechanical ventilation and is an important cause of ventilator dependence and withdrawal failure The diaphragm of newborns is the main respiratory muscle of which the diaphragm type 1 endurance fiber accounts for only about 30 far lower than the proportion of about 55 in adults so the diaphragm of newborns is more prone to fatigue Previous animal experiments and clinical studies in children and adults have confirmed that diaphragmatic pacing therapy applied to patients with long-term invasive mechanical ventilation can prevent diaphragmatic atrophy reverse diaphragmatic injury significantly improve diaphragmatic thickness improve diaphragmatic anti-fatigue ability thereby increasing lung ventilation relieving dyspnea and achieving the effect of assisted extubation
The neonatology Department of the Childrens Hospital Affiliated to Chongqing Medical University started neonatal external diaphragm pacemaker treatment in 2022 and has completed 1383 cases so far initially showing the effectiveness and safety of external diaphragm pacemaker treatment in neonatal population But so far there is no systematic evaluation of clinical intervention effect of external diaphragm pacemaker treatment on neonatal respiratory failure patients at home and abroad Based on this the project team intends to conduct a prospective randomized controlled study to systematically evaluate the safety of external diaphragm pacemaker in preterm infants requiring invasive mechanical ventilation for 7 days at 28 to 35 weeks of gestation and to evaluate the efficacy of external diaphragm pacemaker in adjuvant extubation
Detailed Description:
Neonatal respiratory failure is the central or peripheral respiratory dysfunction caused by various reasons and is an important clinical critical disease of newborns With the development of perinatal medicine more and more newborns with respiratory failure can be treated due to the use of respiratory support technology However long-term invasive mechanical ventilation treatment can lead to a series of complications such as ventilator-associated pneumonia atelectasis and air leakage syndrome and increase the risk of bronchopulmonary dysplasia and neurodevelopmental lag of premature infants It also leads to longer hospital stays and higher hospital costs To shorten the invasive mechanical ventilation time and improve the success rate of withdrawal through various ways is the development direction of neonatal mechanical ventilation therapy
Respiratory muscle atrophy is common and rapid in children receiving invasive mechanical ventilation and is an important cause of ventilator dependence and withdrawal failure The diaphragm of newborns is the main respiratory muscle of which the diaphragm type 1 endurance fiber accounts for only about 30 far lower than the proportion of about 55 in adults so the diaphragm of newborns is more prone to fatigue Studies have shown that phrenic atrophy usually begins within 18-69 hours of invasive mechanical ventilation and progresses at a rate of 4-7 per day
Previous animal experiments and clinical studies in children and adults have confirmed that diaphragmatic pacing therapy applied to patients with long-term invasive mechanical ventilation can prevent diaphragmatic atrophy reverse diaphragmatic injury significantly improve diaphragmatic thickness improve diaphragmatic anti-fatigue ability thereby increasing lung ventilation relieving dyspnea and achieving the effect of assisted extubation
In February 1987 the external diaphragm pacemaker independently developed by Chen et al at Sun Yat-sen University of Medical Science was applied to clinical practice setting a precedent for external diaphragmatic pacing at home and abroad The basic principle is to perform low-frequency pulse electrical stimulation of the phrenic nerve through the electrodes on the body surface to make the regular contraction and relaxation of the diaphragm and increase the degree of movement of the diaphragm so as to improve the ventilation function of the patient In China Cai et al observed that external diaphragm pacemaker can increase the degree of immediate diaphragm movement in normal people and significantly increase the degree of immediate movement in patients with chronic obstructive pulmonary disease and the range of diaphragm movement after continuous treatment for 20-30 days and significantly improve the symptoms of dyspnea
The neonatology Department of the Childrens Hospital Affiliated to Chongqing Medical University started neonatal external diaphragm pacemaker treatment in 2022 and has completed 1383 cases so far initially showing the effectiveness and safety of external diaphragm pacemaker treatment in neonatal population But so far there is no systematic evaluation of clinical intervention effect of external diaphragm pacemaker treatment on neonatal respiratory failure patients at home and abroad Based on this the project team intends to conduct a prospective randomized controlled study to systematically evaluate the safety of external diaphragm pacemaker in preterm infants requiring invasive mechanical ventilation for 7 days at 28 to 35 weeks of gestation and to evaluate the efficacy of external diaphragm pacemaker in adjuvant extubation
Respiratory muscle atrophy is common and rapid in children receiving invasive mechanical ventilation and is an important cause of ventilator dependence and withdrawal failure The diaphragm of newborns is the main respiratory muscle of which the diaphragm type 1 endurance fiber accounts for only about 30 far lower than the proportion of about 55 in adults so the diaphragm of newborns is more prone to fatigue Studies have shown that phrenic atrophy usually begins within 18-69 hours of invasive mechanical ventilation and progresses at a rate of 4-7 per day
Previous animal experiments and clinical studies in children and adults have confirmed that diaphragmatic pacing therapy applied to patients with long-term invasive mechanical ventilation can prevent diaphragmatic atrophy reverse diaphragmatic injury significantly improve diaphragmatic thickness improve diaphragmatic anti-fatigue ability thereby increasing lung ventilation relieving dyspnea and achieving the effect of assisted extubation
In February 1987 the external diaphragm pacemaker independently developed by Chen et al at Sun Yat-sen University of Medical Science was applied to clinical practice setting a precedent for external diaphragmatic pacing at home and abroad The basic principle is to perform low-frequency pulse electrical stimulation of the phrenic nerve through the electrodes on the body surface to make the regular contraction and relaxation of the diaphragm and increase the degree of movement of the diaphragm so as to improve the ventilation function of the patient In China Cai et al observed that external diaphragm pacemaker can increase the degree of immediate diaphragm movement in normal people and significantly increase the degree of immediate movement in patients with chronic obstructive pulmonary disease and the range of diaphragm movement after continuous treatment for 20-30 days and significantly improve the symptoms of dyspnea
The neonatology Department of the Childrens Hospital Affiliated to Chongqing Medical University started neonatal external diaphragm pacemaker treatment in 2022 and has completed 1383 cases so far initially showing the effectiveness and safety of external diaphragm pacemaker treatment in neonatal population But so far there is no systematic evaluation of clinical intervention effect of external diaphragm pacemaker treatment on neonatal respiratory failure patients at home and abroad Based on this the project team intends to conduct a prospective randomized controlled study to systematically evaluate the safety of external diaphragm pacemaker in preterm infants requiring invasive mechanical ventilation for 7 days at 28 to 35 weeks of gestation and to evaluate the efficacy of external diaphragm pacemaker in adjuvant extubation
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