Ignite Creation Date:
2024-05-05 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00159939
Status:
COMPLETED
Last Update Posted:
2008-06-11
First Post:
2005-09-07
Brief Title:
Prone-Supine Study II The Effect of Prone Positioning for Patients Affected by Acute Respiratory Distress Syndrome
Sponsor:
Policlinico Hospital
Organization:
Policlinico Hospital
Study Overview
Official Title:
Prone-Supine Study II The Effect of Prone Positioning for Patients Affected by Acute Respiratory Distress Syndrome
Status:
COMPLETED
Status Verified Date:
2008-06
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:
The purpose of this study is to determine whether prone positioning is effective in improving survival in patients affected by acute respiratory distress syndrome ARDS
Detailed Description:
BACKGROUND The beneficial effect of prone positioning on arterial oxygenation has been well demonstrated in ALIARDS patients Moreover prone positioning has an impact on the distribution of the lung densities Finally after a period of prone position the respiratory compliance and the arterial oxygenation markedly improve compared to the pre-pronation values Overall these evidences suggests that the prone positioning may affect the outcome of ARDS patients Recently we reported the effect of prone positioning on the outcome of ARDS patients In this study the treatment consisted of 6 hours of pronation daily for the first ten days after the onset of acute respiratory failure Although we did not find any difference of outcome in the general population of ARDS patients at ten days at discharge from ICU and after 6 months a post hoc analysis identified a reduction in mortality at the end of the 10-days treatment period in the quartile of patients affected by most severe ARDS A critical analysis of some of the methodological weaknesses of the previous study together with the new information emerging from other studies led to the adoption of major changes in the overall conception as well as in the operational design of the protocol
a substantial prolongation of the daily exposure to the prone position from 6 up to a minimum of 20 hours
the abolition of a time window for the duration of treatment which is not stopped except in coincidence with weaning of the patient
a predefined scheme for applying mechanical ventilation in both groups based on the lung protective strategy concept
OBJECTIVE To assess the effect of prone positioning on mortality in ARDS patients stratified at randomization according to predefined criteria of severity of respiratory failure
STUDY DESIGN This is a randomized controlled multi-center study The patients will be randomized in two groups
Controls will receive optimised standard intensive treatment including protective ventilatory strategy
Treatment extended at least 20 hrs daily prone positioning is added to control treatment
STUDY PROCEDURES As soon as patients are assessed in terms of inclusion and exclusion criteria they should be notified to the coordination center to be assigned to either the control or the treatment group according to a randomization scheme which includes stratification by severity of ARDS On the basis of the respiratory failure severity at baseline patients will be stratified as
Mild ARDS 100PaO2FiO2200 with 5PEEP10 cmH2O
Severe ARDS PaO2FiO2100 with 5 cmH2O PEEP
The patients enrolled in both the randomization arms will be ventilated according to a protective strategy
The prone positioning will be preferentially performed with the RotoProne bed
The patients assigned to the treatment group must be put in a prone position daily
for at least 20 hours any variation 2 hrs must be motivated in the CRF
for up to 28 days
Major non-compliance with the randomized treatment prone positioning for the control and withdrawal for the intervention group will be motivated in the CRF and they are expected to occur only to better protect the well-being of the patients The originally assigned randomized strategy must be re-established as soon as possible
The end of the study treatment period is at 28 days from the randomization or at the extubation whichever occurs first
DATA COLLECTION The data collection forms will be sent to the Coordinating Center The data should be collected at 12 hours interval two times daily We will perform a Morning assessment and a Evening assessment The assessments should be done after at least 30 minutes from any manoeuvre that could affect the measurement ig patient rolling for nursing bronchoaspiration
Controls group both morning and Evening assessments will be done in supine position at 12 hours interval
Treatment group the Morning assessment should be done in supine position and after at least 45 minutes the patient is in supine position in the Evening assessment the data has to be collected in prone position and after at least 60 minutes the patient is in that position
SAFETY ASPECTS AND SEVERE ADVERSE EVENTS SAE REPORTING GCP rules will be strictly applied including timely reporting to the study coordination within 48 hours from their occurrence of the SAEs not included in the efficacy end-points
Clinical investigators and nurses of each of the participating centers will be instructed to monitor specifically and to document the adverse events more likely to be associated with the study treatment
STUDY ORGANIZATION AND MONITORING The centers which are admitted to the study have been selected on the basis of their previous involvement in multicenter clinical trials and the clinical experience in the application of prone position These criteria will favour both the homogeneity andor comparability of the standard background treatment as well as the monitoring of the quality of the data
The overall coordination of the study is the task of an interdisciplinary group which assures
the initial training of the investigators
the real-time monitoring of all data foreseen in the CRF through a close feed-back with each center
availability of a permanent 24 hours phone help-line to answer clinical and operational queries originated by the centers
the periodical organization at least 2yr of meetings among the participating teams investigators and nurses to ensure an interactive discussion of emerging problems
the overall quality control and management of the study data-base
STATISTICAL ASPECTS The characteristics of the trial relative low frequency of the clinical condition unavoidable concentration of the proning instrument in a limited number of centers in opportunity of an excessive prolongation of the recruitment period which could coincide with important modifications of the way the background care develops need to be considered when defining the sample size
The primary outcome of the study is the overall mortality at 28 days from randomisation and it is used for sample size calculations The study is planned to detect a 15 percent of absolute decrease in 28 day mortality at a power of 80 percent enrolling 170 patients in each arms The main analysis will be performed according to an intention-to-treat approach
The primary endpoint will be monitored using the sequential procedure of Peto et al There will one interim analysis to assess efficacy scheduled at approximately ½ of expected number of patients to be recruited Accordingly the corresponding significance level for evidence of benefit to stop the trial will be α001
ADMINISTRATIVE LEGAL ETHICAL ISSUES The Prone-Supine 2 study is sponsored by a collaborative group which has been active over the last ten years in conducting clinical trials in intensive care 5 10The study has been planned and is managed independently and the clinicians who take active part in the study do not receive economic incentives The RotoProne bed is provided to each center by the producer KCI Medical Products San Antonio TX USA who ensures also a small financial support for the study co-ordination 50000 USDyears
The data which are produced belong to the study group who ensures their publication and their availability for public authorities
All data related to the patients included in the study are treated in strict compliance with the Italian Laws related to privacy 6751996
The informed consent for the patients will be administered as soon as and every time the clinical conditions of the same patients are compatible with the procedure thus following the provisions set forth by the ICH-GCP guidelines 11 and confirmed by the most recent European Directive 200120CE Decreto Legislativo 211 24062003 It is worth recalling that there is no legal basis for requiring the consent to a relative of the patient
COMMITTEES
Steering Committee L Gattinoni G Tognoni Scientific and Organizing Secretariat R Fumagalli R Latini A Pesenti PTaccone Nursing Coordination G Saia W Rositani V Del Bello Data and Safety Monitoring Board R Malacrida MG Valsecchi P Suter Data Management and Analysis E Nicolis S Barlera
a substantial prolongation of the daily exposure to the prone position from 6 up to a minimum of 20 hours
the abolition of a time window for the duration of treatment which is not stopped except in coincidence with weaning of the patient
a predefined scheme for applying mechanical ventilation in both groups based on the lung protective strategy concept
OBJECTIVE To assess the effect of prone positioning on mortality in ARDS patients stratified at randomization according to predefined criteria of severity of respiratory failure
STUDY DESIGN This is a randomized controlled multi-center study The patients will be randomized in two groups
Controls will receive optimised standard intensive treatment including protective ventilatory strategy
Treatment extended at least 20 hrs daily prone positioning is added to control treatment
STUDY PROCEDURES As soon as patients are assessed in terms of inclusion and exclusion criteria they should be notified to the coordination center to be assigned to either the control or the treatment group according to a randomization scheme which includes stratification by severity of ARDS On the basis of the respiratory failure severity at baseline patients will be stratified as
Mild ARDS 100PaO2FiO2200 with 5PEEP10 cmH2O
Severe ARDS PaO2FiO2100 with 5 cmH2O PEEP
The patients enrolled in both the randomization arms will be ventilated according to a protective strategy
The prone positioning will be preferentially performed with the RotoProne bed
The patients assigned to the treatment group must be put in a prone position daily
for at least 20 hours any variation 2 hrs must be motivated in the CRF
for up to 28 days
Major non-compliance with the randomized treatment prone positioning for the control and withdrawal for the intervention group will be motivated in the CRF and they are expected to occur only to better protect the well-being of the patients The originally assigned randomized strategy must be re-established as soon as possible
The end of the study treatment period is at 28 days from the randomization or at the extubation whichever occurs first
DATA COLLECTION The data collection forms will be sent to the Coordinating Center The data should be collected at 12 hours interval two times daily We will perform a Morning assessment and a Evening assessment The assessments should be done after at least 30 minutes from any manoeuvre that could affect the measurement ig patient rolling for nursing bronchoaspiration
Controls group both morning and Evening assessments will be done in supine position at 12 hours interval
Treatment group the Morning assessment should be done in supine position and after at least 45 minutes the patient is in supine position in the Evening assessment the data has to be collected in prone position and after at least 60 minutes the patient is in that position
SAFETY ASPECTS AND SEVERE ADVERSE EVENTS SAE REPORTING GCP rules will be strictly applied including timely reporting to the study coordination within 48 hours from their occurrence of the SAEs not included in the efficacy end-points
Clinical investigators and nurses of each of the participating centers will be instructed to monitor specifically and to document the adverse events more likely to be associated with the study treatment
STUDY ORGANIZATION AND MONITORING The centers which are admitted to the study have been selected on the basis of their previous involvement in multicenter clinical trials and the clinical experience in the application of prone position These criteria will favour both the homogeneity andor comparability of the standard background treatment as well as the monitoring of the quality of the data
The overall coordination of the study is the task of an interdisciplinary group which assures
the initial training of the investigators
the real-time monitoring of all data foreseen in the CRF through a close feed-back with each center
availability of a permanent 24 hours phone help-line to answer clinical and operational queries originated by the centers
the periodical organization at least 2yr of meetings among the participating teams investigators and nurses to ensure an interactive discussion of emerging problems
the overall quality control and management of the study data-base
STATISTICAL ASPECTS The characteristics of the trial relative low frequency of the clinical condition unavoidable concentration of the proning instrument in a limited number of centers in opportunity of an excessive prolongation of the recruitment period which could coincide with important modifications of the way the background care develops need to be considered when defining the sample size
The primary outcome of the study is the overall mortality at 28 days from randomisation and it is used for sample size calculations The study is planned to detect a 15 percent of absolute decrease in 28 day mortality at a power of 80 percent enrolling 170 patients in each arms The main analysis will be performed according to an intention-to-treat approach
The primary endpoint will be monitored using the sequential procedure of Peto et al There will one interim analysis to assess efficacy scheduled at approximately ½ of expected number of patients to be recruited Accordingly the corresponding significance level for evidence of benefit to stop the trial will be α001
ADMINISTRATIVE LEGAL ETHICAL ISSUES The Prone-Supine 2 study is sponsored by a collaborative group which has been active over the last ten years in conducting clinical trials in intensive care 5 10The study has been planned and is managed independently and the clinicians who take active part in the study do not receive economic incentives The RotoProne bed is provided to each center by the producer KCI Medical Products San Antonio TX USA who ensures also a small financial support for the study co-ordination 50000 USDyears
The data which are produced belong to the study group who ensures their publication and their availability for public authorities
All data related to the patients included in the study are treated in strict compliance with the Italian Laws related to privacy 6751996
The informed consent for the patients will be administered as soon as and every time the clinical conditions of the same patients are compatible with the procedure thus following the provisions set forth by the ICH-GCP guidelines 11 and confirmed by the most recent European Directive 200120CE Decreto Legislativo 211 24062003 It is worth recalling that there is no legal basis for requiring the consent to a relative of the patient
COMMITTEES
Steering Committee L Gattinoni G Tognoni Scientific and Organizing Secretariat R Fumagalli R Latini A Pesenti PTaccone Nursing Coordination G Saia W Rositani V Del Bello Data and Safety Monitoring Board R Malacrida MG Valsecchi P Suter Data Management and Analysis E Nicolis S Barlera
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