Ignite Creation Date:
2024-05-05 @ 6:36 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00510770
Status:
UNKNOWN
Last Update Posted:
2009-02-18
First Post:
2007-08-01
Brief Title:
CPAP in Liver Transplant
Sponsor:
University of Turin Italy
Organization:
University of Turin Italy
Study Overview
Official Title:
Continuous Positive Airway Pressure for Treatment of Postoperative Hypoxemia in Liver Transplant
Status:
UNKNOWN
Status Verified Date:
2009-02
Last Known Status:
RECRUITING
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 the effectiveness of continuous positive airway pressure compared to standard treatment in preventing the need for intubation and mechanical ventilation in patients who develop acute hypoxemia after liver transplant
Hypoxemia complicates the recovery of 30-50 of patients after abdominal surgery endotracheal intubation and mechanical ventilation may be required in 8-10 of cases increasing morbidity and mortality and prolonging intensive care unit and hospital stay
Hypoxemia complicates the recovery of 30-50 of patients after abdominal surgery endotracheal intubation and mechanical ventilation may be required in 8-10 of cases increasing morbidity and mortality and prolonging intensive care unit and hospital stay
Detailed Description:
Recovery from abdominal surgery is usually fast and uncomplicated but postoperative hypoxemia complicates 30-50 of cases even in uneventful procedures 1 Although oxygen administration and incentive spirometry are effective in treating the vast majority of postoperative hypoxemia cases 2 respiratory failure may occur early in the postoperative course 3 requiring endotracheal intubation and mechanical ventilation in 8-10 of patients thus increasing morbidity and mortality and prolonging intensive care unit and hospital stay 1-4 Loss of functioning alveolar units has been recognized as the underlying mechanism responsible for postoperative hypoxemia 5-7 pulmonary atelectasis after abdominal surgery is in fact common it may exceed 25 of the total lung volume and is seen several days after surgery 5-7
Continuous positive airway pressure CPAP is a breathing mode where the patient spontaneously breathes through a pressurized circuit against a threshold resistor that maintains a preset positive airway pressure during both inspiration and expiration Although several studies have demonstrated the efficacy of CPAP to reduce atelectasis and improve oxygenation in patients after abdominal surgery 8-11 no clinical trials have confirmed that the improvement of gas exchange with CPAP actually results in a reduced need for intubation and mechanical ventilation in patients who develop hypoxemia after abdominal surgery 12 We conducted a multi-center prospective randomized clinical trial to compare the efficacy of CPAP with standard oxygen therapy in the treatment of postoperative hypoxemia The present study set out to examine the hypothesis that early application of CPAP may prevent intubation and mechanical ventilation in patients who develop acute hypoxemia after liver transplant
Concealed randomization was conducted centrally through a dedicated web site using a computer-generated block randomization schedule
Patients were randomized to be treated for six hours with oxygen through a Venturi mask at a FiO2 of 05 control or with oxygen at a FiO2 of 05 plus a CPAP of 75 cm H2O CPAP At the end of the 6-hour period patients passed a one-hour screening test breathing oxygen through a Venturi mask at a FiO2of 03 Patients returned to the assigned treatment if the PaO2FiO2 ratio was less than or equal to 300 treatment was interrupted if the PaO2FiO2 ratio was higher than 300 Nasal oxygen 8-10 literminute was given if the treatment was not tolerated Figure 1
In all centers CPAP was generated using a flow generator with an adjustable inspiratory oxygen fraction set to deliver a flow of up to 140 liters per minute Whisperflow Caradyne Ireland and a spring-loaded expiratory pressure valve Vital Signs Inc Totoma NJ and applied using a latex-free polyvinyl chloride transparent helmet CaStar Starmed Italy 15 all centers measured the inspiratory oxygen fraction using an oxygen analyzer Oxicheck Caradyne Ireland through the Venturi mask or the helmet
All analyses were conducted on an intention-to-treat basis Values are reported as mean and standard deviation Continuous variables were compared with the use of the unpaired t-test or the Wilcoxon rank-sum test depending on their distributional characteristics Categorical variables were compared with the use of Fishers exact test or the chi-square test when appropriate The Kaplan-Meier curve for intubation rate was plotted and was compared by the log-rank and Wilcoxon tests All reported P values are two-sided
Continuous positive airway pressure CPAP is a breathing mode where the patient spontaneously breathes through a pressurized circuit against a threshold resistor that maintains a preset positive airway pressure during both inspiration and expiration Although several studies have demonstrated the efficacy of CPAP to reduce atelectasis and improve oxygenation in patients after abdominal surgery 8-11 no clinical trials have confirmed that the improvement of gas exchange with CPAP actually results in a reduced need for intubation and mechanical ventilation in patients who develop hypoxemia after abdominal surgery 12 We conducted a multi-center prospective randomized clinical trial to compare the efficacy of CPAP with standard oxygen therapy in the treatment of postoperative hypoxemia The present study set out to examine the hypothesis that early application of CPAP may prevent intubation and mechanical ventilation in patients who develop acute hypoxemia after liver transplant
Concealed randomization was conducted centrally through a dedicated web site using a computer-generated block randomization schedule
Patients were randomized to be treated for six hours with oxygen through a Venturi mask at a FiO2 of 05 control or with oxygen at a FiO2 of 05 plus a CPAP of 75 cm H2O CPAP At the end of the 6-hour period patients passed a one-hour screening test breathing oxygen through a Venturi mask at a FiO2of 03 Patients returned to the assigned treatment if the PaO2FiO2 ratio was less than or equal to 300 treatment was interrupted if the PaO2FiO2 ratio was higher than 300 Nasal oxygen 8-10 literminute was given if the treatment was not tolerated Figure 1
In all centers CPAP was generated using a flow generator with an adjustable inspiratory oxygen fraction set to deliver a flow of up to 140 liters per minute Whisperflow Caradyne Ireland and a spring-loaded expiratory pressure valve Vital Signs Inc Totoma NJ and applied using a latex-free polyvinyl chloride transparent helmet CaStar Starmed Italy 15 all centers measured the inspiratory oxygen fraction using an oxygen analyzer Oxicheck Caradyne Ireland through the Venturi mask or the helmet
All analyses were conducted on an intention-to-treat basis Values are reported as mean and standard deviation Continuous variables were compared with the use of the unpaired t-test or the Wilcoxon rank-sum test depending on their distributional characteristics Categorical variables were compared with the use of Fishers exact test or the chi-square test when appropriate The Kaplan-Meier curve for intubation rate was plotted and was compared by the log-rank and Wilcoxon tests All reported P values are two-sided
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