NCT01726140

Brief Summary

The aim of study is to evaluate whether the application of a continuous positive airway pressure (CPAP) after extubation in patients undergoing cardiac surgery can reduce hypoxemia and re-intubation rate.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
407

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 6, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 14, 2012

Completed
5 months until next milestone

Study Start

First participant enrolled

April 1, 2013

Completed
10.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2024

Completed
Last Updated

March 17, 2025

Status Verified

March 1, 2025

Enrollment Period

10.3 years

First QC Date

November 6, 2012

Last Update Submit

March 12, 2025

Conditions

Acute Respiratory Failure Requiring Reintubation

Keywords

intubationrespiratory failurecardiac surgery

Outcome Measures

Primary Outcomes (1)

  • rate of re-intubation

    at 28 days

Secondary Outcomes (6)

  • incidence of atelectasis

    at 28 days

  • incidence of pneumonia

    at 28 days

  • incidence of sepsis

    at 28 days

  • mortality rate

    at 28 days

  • the intensive care unit length of stay

    at 28 days

  • +1 more secondary outcomes

Study Arms (2)

TREATMENT

EXPERIMENTAL

Helmet CPAP

Procedure: Helmet CPAP

CONTROL

ACTIVE COMPARATOR

Venturi Mask

Procedure: Venturi Mask

Interventions

Helmet CPAPPROCEDURE

the patient will receive CPAP treatment, at a PEEP level of 10 cmH2O and a FiO2 adjusted to maintain SpO2\>95%, for six hours. After three hours of treatment a blood gas analysis will be evaluated and the patient will proceed with the treatment for three more hours. At the end of the six hours, the patient will repeat a spontaneous breathing trial with a Venturi mask at FiO2 = 50%, for 15 minutes and than a blood gas analysis will be repeated: if the PaO2/FiO2 will be \< 200 the patient will received a second treatment with CPAP; if PaO2/FiO2 will be \>200, the patient will stop the treatment.

TREATMENT
Venturi MaskPROCEDURE

the patient will maintain spontaneous breathing, with a system for oxygen delivery at a FiO2 adjusted to maintain SpO2\>95%, for six hours. After three hours of treatment a blood gas analysis will be evaluated and the patient will proceed with the treatment for three more hours. At the end of the six hours, the patient will do a trial for 15 minutes and after that a blood gas analysis will be repeated: if the PaO2/FiO2 will be \< 200 the patient will go on with the control treatment; if PaO2 /FiO2 will be \>200, the patient will stop the treatment.

CONTROL

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients undergoing cardiac surgery on cardiopulmonary bypass
  • PaO2 /FiO2 \< 200 after extubation
  • extubation time \< 24 h.

You may not qualify if:

  • patients \< 18 years old
  • extracorporeal membrane oxygenation
  • severe cardiac dysfunction (FE\<25%)
  • mechanical ventilation before the intervention
  • severe COPD (patients on oxygen therapy, with a FEV1\< 50%)
  • heart or lung transplantation
  • lack of consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Turin - Department of Anesthesia and Intensive Care Medicine

Turin, 10126, Italy

Location

Related Publications (1)

  • Pasero D, Costamagna A, Filippini C, Blangetti I, Cattaneo S, Baiocchi M, Balata A, Bottiroli M, Dambruoso P, De Paulis S, Grazioli L, Locatelli A, Lorini FL, Mascotti A, Mondino MG, Paparella D, Salvi L, Tonetti T, Tritapepe L, Ranieri VM. Continuous positive airway pressure to prevent reintubation in patients recovering from cardiac surgery: A multicentre randomised clinical trial. Eur J Anaesthesiol. 2025 Nov 1;42(11):958-965. doi: 10.1097/EJA.0000000000002229. Epub 2025 Jun 27.

    PMID: 40574561DERIVED

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract Diseases

Study Officials

  • Vito Marco VM Ranieri, MD

    University of Turin, Italy

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 6, 2012

First Posted

November 14, 2012

Study Start

April 1, 2013

Primary Completion

July 1, 2023

Study Completion

January 1, 2024

Last Updated

March 17, 2025

Record last verified: 2025-03

Locations

IT(1)