Temporary transvenous diaphragm pacing vs. standard of care for weaning from mechanical ventilation: study protocol for a randomized trial.
Airway Extubation
Diaphragm
/ diagnostic imaging
Electric Stimulation Therapy
/ adverse effects
France
Germany
Humans
Length of Stay
Lung
/ physiopathology
Multicenter Studies as Topic
Patient Discharge
Prospective Studies
Randomized Controlled Trials as Topic
Recovery of Function
Respiration
Respiration, Artificial
Respiratory Function Tests
Respiratory Insufficiency
/ diagnosis
Time Factors
Treatment Outcome
Ultrasonography
Ventilator Weaning
/ adverse effects
Diaphragm
Mechanical ventilation
Phrenic stimulation
Ventilator-induced diaphragmatic dysfunction
Weaning
Journal
Trials
ISSN: 1745-6215
Titre abrégé: Trials
Pays: England
ID NLM: 101263253
Informations de publication
Date de publication:
17 Jan 2019
17 Jan 2019
Historique:
received:
25
09
2018
accepted:
31
12
2018
entrez:
19
1
2019
pubmed:
19
1
2019
medline:
1
6
2019
Statut:
epublish
Résumé
Mechanical ventilation (MV) is a life-saving technology that restores or assists breathing. Like any treatment, MV has side effects. In some patients it can cause diaphragmatic atrophy, injury, and dysfunction (ventilator-induced diaphragmatic dysfunction, VIDD). Accumulating evidence suggests that VIDD makes weaning from MV difficult, which involves increased morbidity and mortality. This paper describes the protocol of a randomized, controlled, open-label, multicenter trial that is designed to investigate the safety and effectiveness of a novel therapy, temporary transvenous diaphragm pacing (TTVDP), to improve weaning from MV in up to 88 mechanically ventilated adult patients who have failed at least two spontaneous breathing trials over at least 7 days. Patients will be randomized (1:1) to TTVDP (treatment) or standard of care (control) groups. The primary efficacy endpoint is time to successful extubation with no reintubation within 48 h. Secondary endpoints include maximal inspiratory pressure and ultrasound-measured changes in diaphragm thickness and diaphragm thickening fraction over time. In addition, observational data will be collected and analyzed, including 30-day mortality and time to discharge from the intensive care unit and from the hospital. The hypothesis to be tested postulates that more TTVDP patients than control patients will be successfully weaned from MV within the 30 days following randomization. This study is the first large-scale clinical trial of a novel technology (TTVDP) aimed at accelerating difficult weaning from MV. The technology tested provides the first therapy directed specifically at VIDD, an important cause of delayed weaning from MV. Its results will help delineate the place of this therapeutic approach in clinical practice and help design future studies aimed at defining the indications and benefits of TTVDP. ClinicalTrials.gov, NCT03096639 . Registered on 30 March 2017.
Sections du résumé
BACKGROUND
BACKGROUND
Mechanical ventilation (MV) is a life-saving technology that restores or assists breathing. Like any treatment, MV has side effects. In some patients it can cause diaphragmatic atrophy, injury, and dysfunction (ventilator-induced diaphragmatic dysfunction, VIDD). Accumulating evidence suggests that VIDD makes weaning from MV difficult, which involves increased morbidity and mortality.
METHODS AND ANALYSIS
METHODS
This paper describes the protocol of a randomized, controlled, open-label, multicenter trial that is designed to investigate the safety and effectiveness of a novel therapy, temporary transvenous diaphragm pacing (TTVDP), to improve weaning from MV in up to 88 mechanically ventilated adult patients who have failed at least two spontaneous breathing trials over at least 7 days. Patients will be randomized (1:1) to TTVDP (treatment) or standard of care (control) groups. The primary efficacy endpoint is time to successful extubation with no reintubation within 48 h. Secondary endpoints include maximal inspiratory pressure and ultrasound-measured changes in diaphragm thickness and diaphragm thickening fraction over time. In addition, observational data will be collected and analyzed, including 30-day mortality and time to discharge from the intensive care unit and from the hospital. The hypothesis to be tested postulates that more TTVDP patients than control patients will be successfully weaned from MV within the 30 days following randomization.
DISCUSSION
CONCLUSIONS
This study is the first large-scale clinical trial of a novel technology (TTVDP) aimed at accelerating difficult weaning from MV. The technology tested provides the first therapy directed specifically at VIDD, an important cause of delayed weaning from MV. Its results will help delineate the place of this therapeutic approach in clinical practice and help design future studies aimed at defining the indications and benefits of TTVDP.
TRIAL REGISTRATION
BACKGROUND
ClinicalTrials.gov, NCT03096639 . Registered on 30 March 2017.
Identifiants
pubmed: 30654837
doi: 10.1186/s13063-018-3171-9
pii: 10.1186/s13063-018-3171-9
pmc: PMC6337771
doi:
Banques de données
ClinicalTrials.gov
['NCT03096639']
Types de publication
Clinical Trial Protocol
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
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