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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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.

Squadrone SV Vincenzo, MD contact

+39 011 6335500

vsquadrone@molinette.piemonte.it

Italy1 site, 1 recruiting
  • Università degli Studi Torino

    Turin, Piedmont, 10100

    Pelizzetti PE Ezio, Rettore, +39 011 6702200 ext. 2201, rettore@unito.it

    Recruiting

Other trials in Italy

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.

  1. Intubation, need of mechanical ventilation

Secondary outcomes (1)
  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.

  1. First posted2 Aug 2007 (estimated)
  2. Study startDec 2004

Resources

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)
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

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.

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