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Completed

NCT Number: NCT00507533

Early Application of CPAP in Hematologic

The purpose of this study is to evaluate the use of CPAP in the prevention of acute respiratory failure in neutropenic ( or hematologic malignancy ) patients .CPAP applied preventively in hematological patients with high risk of ARF may reduce:need for intubations and mechanical ventilation, incidence of pneumonia and sepsis,mortality,length of ICU and hospital stay

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Università degli Studi Torino

Turin, Piedmont, 10100, Italy

About this study

Immunocompromised patients with a hematological malignancy that requiring admission in intensive care unit (ICU) and subsequently mechanical ventilation for respiratory failure was estimated between 20- 50 per cent of all admitted in hospital.

The survival rate of this patients that requiring mechanical ventilation is very poor.

In many cases the immunodepression with a great improvement in severe complication as infections , pneumonia, sepsis , is the consequence of our therapy ( chemotherapy , bone marrow transplantation and stem cell transplantation ) .

Pneumonia is very common cause of mechanical ventilation in about 45-74 per cent of the all patient with acute respiratory failure (ARF) .

The trial was designed to enroll 40 patients in two groups to demonstrate reduction from 50% to 10 % of the need of mechanical ventilation , with a type I risk of error of 5% and a power of 80 %.

Patients were randomized to be treated for four days Venturi mask at a FiO2 of 0.4 (control) or with oxygen at a FiO2 of 0.4 plus a CPAP of 10 cm H2O (CPAP). At the end of the 4-days period, patients passed a screening test breathing ambient air. Patients returned to the assigned treatment if SaO2 less than 95% a.a or respiratory rate more than 25 bpm.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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Neutropenic hematological patients ( less than 1000 leukocytes /mm3 ) .
  • SaO2 less than 95% ( a.a.) ,
  • Respiratory rate (RR ) more than 25 breaths/minute .

Exclusion criteria

  • NYHA class II- III- IV or unstable angina or MI
  • Valvular heart disease or cardiac surgery ( previous 3 months)
  • Implanted cardiac pacemaker
  • BMI less than 40
  • History of dilated cardiomyopathy or CPE
  • Severe COPD ( oxygen therapy , recent exacerbation, hypoxemic-hypercapnic to resting , FEV1 < 50 %)
  • Diagnosis of sleep or neuromuscular disorders.
  • Claustrophobia .
  • Mechanical ventilation criteria:
  • Severe hypoxemia (arterial oxygen saturation < 80 % with maximal FiO2 )
  • Ph < 7.3 with a PaCO2 > 50 mmHg
  • Signs of patient distress with accessory muscle recruitment and paradoxal abdomen movement
  • RR > 35 breaths/minute .

Treatment and study plan

Continuous Positive Airway Pressure

Procedure

Primary outcomes

  1. mechanical ventilation and intubation

Secondary outcomes

  1. Pneumonia , sepsis , ICU LOS , Hospital LOS , Mortality

Sponsors and collaborators

Lead sponsor

University of Turin, Italy

Other

Collaborators

  • Azienda Ospedaliera San Giovanni Battista

Registry information

Official study title

Early Application of CPAP in Hematologic Neutropenic Patients Avoid Acute Respiratory Failure

Acronym: HEMOCPAP

Important dates

Study start
2005
Primary completion
2007
First posted
Jul 26, 2007
Registry last updated
Feb 18, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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