CPAP in Liver Transplant

NCT00510770 | Unknown Phase 4 DMC

• 1 other identifier: CPAP-1-LT
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypoxemia

Keywords

CPAP; Post-opreative; ARF; liver transplant; Post-operative hypoxemia in liver transplant

Outcome Measures

Primary Outcomes (1)

• Intubation, need of mechanical ventilation

Secondary Outcomes (1)

• Wound infection, ICU Los , Hospital Los

Interventions

CPAP application DEVICE

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• University of Turin, Italy: lead

Study Sites (1)

Università degli Studi Torino

Turin, Piedmont, 10100, Italy

RECRUITING

MeSH Terms

Conditions

Hypoxia

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Squadrone SV Vincenzo, MD

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Squadrone SV Vincenzo, MD

CONTACT

+39 011 6335500; vsquadrone@molinette.piemonte.it

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 1, 2007
• First Posted: August 2, 2007
• Study Start: December 1, 2004
• Last Updated: February 18, 2009

Record last verified: 2009-02

Locations

IT (1)