Skip to main content
OpenTrials
Completed

NCT Number: NCT01510275

Combined Use of Respiratory Devices After Thoracic Surgery

In a rehabilitation setting, respiratory muscle training with re-expansion techniques in patients following cardio-thoracic surgery represents a consolidated intervention. New devices called RESPILIFT® and RESPIVOl® improve deep inspiration and pulmonary volume with an effect on respiratory muscle performance and perceived dispnoea. The aim of the investigators study is to test the clinical efficacy of RESPILIFT® and RESPIVOl® in patients with a recent history of cardio-thoracic surgery.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Dyspnea Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory Well Being

Age range

19 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Villa Pineta Hospital, Modena, Italy

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • > 18 years old
  • recent cardio-thoracic surgery (< 30 days of admission)
  • compliance to pulmonary rehabilitation program

Exclusion criteria

  • clinical instability
  • concomitant severe co-morbidities
  • inability to use respiratory devices

Treatment and study plan

Combined use of RESPIVOL® and RESPILIFT®

Device

Active devices (combined) for 14 consecutive session, bid, for 15 minutes.

Primary outcomes

  1. Respiratory muscle performance

    Time frame: Change from Baseline in MEP at 6 months

    Change of MEP (Maximum Expiratory Pressure)measure

Secondary outcomes

  1. Respiratory muscle performance

    Time frame: Enrollment (T0), Day 8 (T8), at the end (T14) and after 6 months (T6m)

    Change of MIP (Maximum Inspiratory Pressure)measure

  2. Pulmonary volumes

    Time frame: Enrollment (T0), Day 8 (T8), at the end (T14) and after 6 months (T6m)

    Change of Static and dynamic volumes (FEV1,FVC,VC,IC,RV)

  3. Pulmonary gas exchange

    Time frame: Enrollment (T0), at the end (T14) and after 6 months (T6m)

    Change of arterial oxygen(PaO2) and use of oxygen (FiO2) in terms of PaO2/FiO2

  4. Perceived dispnoea, well being and thoracic pain

    Time frame: At enrollment (T0), every day during the treatment (T2,T4, T6, T8, T10, T12), at the end (T14) and after 6 months (T6m)

    Change of perceived dispnoea, well being and thoracic pain measured through validated Visual Analogic Scale (VAS)

  5. Perceived quality of life

    Time frame: Enrollment (T0), at the end (T14) and after 6 months (T6m)

    Change of perceived quality of life through Saint George Respiratory Questionnaire (SGRQ), italian version

Sponsors and collaborators

Lead sponsor

Villa Pineta Hospital

Other

Registry information

Official study title

Efficacy on Combined Use of Respiratory Devices RESPILIFT® and RESPIVOL® in Adult Cardio-thoracic Surgery Patients. Randomized-controlled Study

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Jan 16, 2012
Registry last updated
Oct 26, 2012

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.