Ignite Creation Date:
2024-05-06 @ 4:30 PM
Last Modification Date:
2024-10-26 @ 2:11 PM
Study NCT ID:
NCT05000034
Status:
RECRUITING
Last Update Posted:
2023-08-08
First Post:
2021-08-03
Brief Title:
Nurses-driven Capnography-guided Protocol Weaning From the Mechanical Ventilation at Bedside A Feasibility Study
Sponsor:
CHU de Reims
Organization:
CHU de Reims
Study Overview
Official Title:
Nurses-driven Capnography-guided Protocol Weaning From the Mechanical Ventilation at Bedside A Feasibility Study
Status:
RECRUITING
Status Verified Date:
2023-08
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:
NURSES-WEAN
Brief Summary:
Background Prolonged mechanical ventilation MV exposes patients to increased risk of infection and mortality A weaning protocol WP reduces the duration of MV However these protocols remain complicated to implement in clinical practice These considerations led to the development of automated weaning systems AWS which are expensive and limited to expert centers
Scope of the problem AWS are not yet the standard care because evidence of AWS benefit is weak and several unanswered questions remain regarding their roles in weaning There is a need for building new ways to improve WP Indeed medical staffs compliance with a daily screening of patients to wean is low Moreover modifications in ventilator settings require the availability of physicians at bedside and are rarely modified on a daily basis This leads to impaired weaning process and prolonged MV for patients
Acknowledge gap Capnography CAP has been validated for intubation procedures and integrated into AWS Some studies encouraging use of CAP have shown an optimization of MV a decrease of unnecessary arterial blood gas without impacting patients prognosis However the role of CAP in WP in intensive care units ICU has not been assessed so far
Hypothesis A nurse driven WP based on CAP may improve accuracy of weaning procedures at bedside Such protocol might be easy to apply in daily practice and could reduce both the duration of MV and its related complications
Methods This is a prospective bi-center pilot study to assess the feasibility of a new nurses managed WP based on capnography among patients requiring more of 48 hours of MV Enrollment of 100 consecutive patients in two ICU of the universitary hospital in Reims The primary endpoint is the protocol compliance Secondary endpoints are capacity to performed a weaning time to first extubation total duration of MV caregivers acceptance and feelings regarding the protocol a safety evaluation with report of hospital mortality ventilator associated-pneumonia autoextubation length of stay and the number of ABGpatientday during the study period Inclusion critera all patients on MV for more than 48 hours and stabilization of the ICU entry pathology Exclusion critera Patients with severe neuropathy cardiopathy or pulmonary disease Weaning protocol begins when the following criteria are present PEEP 8 cmH2O PaO2FiO2 ratio 150 mmHg or SaO2 90 with FiO2 05 The final criterion for study entry is successful completion of a 30-min spontaneous breathing test SBT using pressure support PS max 30 cmH2O After a successful test nurse reduces PS by 2 mmHg every 3 hours and the FIO2 as long as the patient remains in his comfort zone defined as FR 12-30min VT 6mlkg and ETCO2 55 mmHg 65 mmHg for chronic obstructive pulmonary disease COPD patients A scale allows FIO2 and PEEP to be titrated with an oxygen saturation between 90 and 98 92 for COPD Nurses recorded every 3 hours ventilatory hemodynamic sedation parameters and modifications At any time physicians can return to the previous settings if the patient is leaving the comfort zone SBT are conducted when a minimum level of PS and PEEP is reached 7cmH20 and 5cmH20 respectively SBT performed using a T piece with or no oxygen for 30-120 min If a patient passes a successful SBT and meets extubation criteria he is extubed Extubation and SBT protocols are performed according to French guidelines SFARSRLF Nevertheless extubation always remains the decision of the attending physician Protocols continue until successful extubation at least 48 hours of unassisted spontaneous breathing ICU death ICU discharge or until day 90 after randomization
Interests and Scientific impacts For patients a potential reduction of VM duration and its associated-complications For caregivers a more efficient WP and a better optimization of workload This pilot study will be a step before to investigate larger studies to compare our WP to standard care
Scope of the problem AWS are not yet the standard care because evidence of AWS benefit is weak and several unanswered questions remain regarding their roles in weaning There is a need for building new ways to improve WP Indeed medical staffs compliance with a daily screening of patients to wean is low Moreover modifications in ventilator settings require the availability of physicians at bedside and are rarely modified on a daily basis This leads to impaired weaning process and prolonged MV for patients
Acknowledge gap Capnography CAP has been validated for intubation procedures and integrated into AWS Some studies encouraging use of CAP have shown an optimization of MV a decrease of unnecessary arterial blood gas without impacting patients prognosis However the role of CAP in WP in intensive care units ICU has not been assessed so far
Hypothesis A nurse driven WP based on CAP may improve accuracy of weaning procedures at bedside Such protocol might be easy to apply in daily practice and could reduce both the duration of MV and its related complications
Methods This is a prospective bi-center pilot study to assess the feasibility of a new nurses managed WP based on capnography among patients requiring more of 48 hours of MV Enrollment of 100 consecutive patients in two ICU of the universitary hospital in Reims The primary endpoint is the protocol compliance Secondary endpoints are capacity to performed a weaning time to first extubation total duration of MV caregivers acceptance and feelings regarding the protocol a safety evaluation with report of hospital mortality ventilator associated-pneumonia autoextubation length of stay and the number of ABGpatientday during the study period Inclusion critera all patients on MV for more than 48 hours and stabilization of the ICU entry pathology Exclusion critera Patients with severe neuropathy cardiopathy or pulmonary disease Weaning protocol begins when the following criteria are present PEEP 8 cmH2O PaO2FiO2 ratio 150 mmHg or SaO2 90 with FiO2 05 The final criterion for study entry is successful completion of a 30-min spontaneous breathing test SBT using pressure support PS max 30 cmH2O After a successful test nurse reduces PS by 2 mmHg every 3 hours and the FIO2 as long as the patient remains in his comfort zone defined as FR 12-30min VT 6mlkg and ETCO2 55 mmHg 65 mmHg for chronic obstructive pulmonary disease COPD patients A scale allows FIO2 and PEEP to be titrated with an oxygen saturation between 90 and 98 92 for COPD Nurses recorded every 3 hours ventilatory hemodynamic sedation parameters and modifications At any time physicians can return to the previous settings if the patient is leaving the comfort zone SBT are conducted when a minimum level of PS and PEEP is reached 7cmH20 and 5cmH20 respectively SBT performed using a T piece with or no oxygen for 30-120 min If a patient passes a successful SBT and meets extubation criteria he is extubed Extubation and SBT protocols are performed according to French guidelines SFARSRLF Nevertheless extubation always remains the decision of the attending physician Protocols continue until successful extubation at least 48 hours of unassisted spontaneous breathing ICU death ICU discharge or until day 90 after randomization
Interests and Scientific impacts For patients a potential reduction of VM duration and its associated-complications For caregivers a more efficient WP and a better optimization of workload This pilot study will be a step before to investigate larger studies to compare our WP to standard care
Detailed Description:
None
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