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Efficacy of non-invasive ventilatory support in the physiotherapy treatment after pulmonary lobectomy

Completed
Conditions
Pulmonary neoplastic or non-neoplastic disease requiring pulmonary lobectomy or bi-lobectomy
Respiratory
Registration Number
ISRCTN13454737
Lead Sponsor
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
All
Target Recruitment
160
Inclusion Criteria

1. Aged between 18 and 78 years
2. Scheduled for pulmonary lobectomy or bi-lobectomy
3. Written informed consent obtenied

Exclusion Criteria

1. Non aderhence or non-tolerating cPAP treatment
2. Need of mechanical ventilation beyond the postoperative day 1
3. Lack of physical ability to be treated by physiotherapy
4. Pulmonary complications after mechanical ventilation
5. Diagnosis of Obstructive Sleep Apnea Syndrome
6. Mini-Mental State Examination score of less than 20

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
1. Pulmonary volumes recovery is measured using the basal spirometry test at baseline, 1 and 4 days postoperatively<br>2. Total number of meters walked is measured using the 6 Minute Walking Test at baseline and 5 days postoperatively<br>3. Length of hospital stay is measured as the number of days from surgical operation to the discharge
Secondary Outcome Measures
NameTimeMethod
1. Gas exchange improvement is measured using systemic arterial blood gas analysis at baseline, 1 and 4 days postoperatively<br>2. Post-operative complications are measured (in particular pneumonia and/or atelectasis documented by Chest X-Ray) through clinical observations throughout the postoperative period<br>3. Chest tube duration is measured as the number of days from operation to the removal of the last chest tube<br>4. Air leak is measured in liters per hours using a digital device of chest drainage at 1, 2, 3, 4 and 5 days postoperatively
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