HypoxemiaPhase 4NCT00510770
CPAP in Liver Transplant
A Phase 4 study testing CPAP application in people with Hypoxemia, run by University of Turin, Italy at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hypoxemia
- What is being tested?
- CPAP application
- Type of treatment
- Medical device
- How many people
- 80 participants
- Where
- 1 siteItaly
- Study dates
- Dec 2004to not given
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients were included in the study if developed an arterial oxygen tension to inspiratory oxygen fraction ratio (PaO2/FiO2) less than or equal to 300
Who cannot join
- Age older than 80 years or younger than 18 years
- New York Heart Association functional class II III or IV
- Valvular heart disease, history of dilated cardiomyopathy, implanted cardiac pace-maker, unstable angina or myocardial infarction/cardiac surgery within the previous three months
- History of chronic obstructive pulmonary disease or asthma
- History of sleep disorders
- Preoperative infection and/or sepsis (13)
Show all 19Show fewer
- Body mass index higher than 40
- Presence of tracheostomy, facial, neck, or chest wall abnormalities
- Requirement of emergency procedure (operation that must be performed as soon as possible and no longer than 12 hours after admission)
- Abdominal aortic aneurysm surgery
- Chemotherapy or immunosuppressive therapy within the previous three months.
- Patients were also excluded if before randomization they showed:
- Arterial pH lower than 7.30 with an arterial carbon dioxide tension higher than 50 mmHg
- Arterial oxygen saturation lower than 80 % with the maximal fraction of inspiratory oxygen; clinical signs of acute myocardial infarction
- Systolic arterial pressure lower than 90 mmHg under optimal fluid therapy
- Presence of criteria for acute respiratory distress syndrome (14)
- Hemoglobin concentration lower than 7 g/dl, serum albumin lower than 3 g/dl
- Creatinine level higher than 3.5 g/dl
- Glasgow Coma Scale lower than 12.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Università degli Studi Torino
Turin, Piedmont, 10100
Pelizzetti PE Ezio, Rettore, +39 011 6702200 ext. 2201, rettore@unito.it
About this study
Official title: Continuous Positive Airway Pressure for Treatment of Postoperative Hypoxemia in Liver Transplant
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.
Read the 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 0.5 (control) or with oxygen at a FiO2 of 0.5 plus a CPAP of 7.5 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 0.3. Patients returned to the assigned treatment if the PaO2/FiO2 ratio was less than or equal to 300; treatment was interrupted if the PaO2/FiO2 ratio was higher than 300. Nasal oxygen (8-10 liter/minute) 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 Fisher's 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.
- Conditions
- Hypoxemia
- Being tested
- CPAP application
- Keywords
- CPAP, Post-opreative, ARF, liver transplant, Post-operative hypoxemia in liver transplant
- Medical subject headings
- Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPAP applicationDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Intubation, need of mechanical ventilation
Secondary outcomes (1)
Wound infection, ICU Los , Hospital Los
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2007 (estimated)
- Study startDec 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypoxemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Turin, Italy
- Sponsor type
- University, hospital or other
- Investigators
- Squadrone SV Vincenzo, MD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00510770
- Sponsor's protocol ID
- CPAP-1-LT
- Status last verified
- Feb 2009
- First submitted
- 1 Aug 2007
- Last updated
- 18 Feb 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Positive Airway Pressure for Treatment of Postoperative Hypoxemia in Liver Transplant
- ClinicalTrials.gov ID
- NCT00510770
- Acronym / sponsor ID
- CPAP-1-LT
- Conditions
- Hypoxemia
- Keywords
- CPAP, Post-opreative, ARF, liver transplant, Post-operative hypoxemia in liver transplant
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of Turin, ItalyUniversity, hospital or other
- Study start
- Dec 2004
- First posted
- 2 Aug 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 0.5 (control) or with oxygen at a FiO2 of 0.5 plus a CPAP of 7.5 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 0.3. Patients returned to the assigned treatment if the PaO2/FiO2 ratio was less than or equal to 300; treatment was interrupted if the PaO2/FiO2 ratio was higher than 300. Nasal oxygen (8-10 liter/minute) 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 Fisher's 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients were included in the study if developed an arterial oxygen tension to inspiratory oxygen fraction ratio (PaO2/FiO2) less than or equal to 300
Key exclusion criteria (19 listed)
- Age older than 80 years or younger than 18 years
- New York Heart Association functional class II III or IV
- Valvular heart disease, history of dilated cardiomyopathy, implanted cardiac pace-maker, unstable angina or myocardial infarction/cardiac surgery within the previous three months
- History of chronic obstructive pulmonary disease or asthma
- History of sleep disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CPAP application | Device | – |
Primary outcome
Intubation, need of mechanical ventilation
1 secondary outcome
Wound infection, ICU Los , Hospital Los
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Squadrone SV Vincenzo, MD principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing CPAP application in people with Hypoxemia, run by University of Turin, Italy at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Squadrone SV Vincenzo, MD (+39 011 6335500, vsquadrone@molinette.piemonte.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intubation, need of mechanical ventilation. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2009.