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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN13454737

Enrollment

160

Registered

2016-04-08

Start date

2012-11-01

Completion date

Unknown

Last updated

2016-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary neoplastic or non-neoplastic disease requiring pulmonary lobectomy or bi-lobectomy Respiratory Pulmonary neoplastic or non-neoplastic disease requiring pulmonary lobectomy or bi-lobectomy

Interventions

Patients are randomly divided in two groups in respect to postoperative physiotherapic treatment: Intervention group: Participants are treated using continuous positive airway pressure (cPAP) (or non

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
1. Pulmonary volumes recovery is measured using the basal spirometry test at baseline, 1 and 4 days postoperatively 2. Total number of meters walked is measured using the 6 Minute Walking Test at baseline and 5 days postoperatively 3. Length of hospital stay is measured as the number of days from surgical operation to the discharge	—

Secondary

Measure	Time frame
1. Gas exchange improvement is measured using systemic arterial blood gas analysis at baseline, 1 and 4 days postoperatively 2. Post-operative complications are measured (in particular pneumonia and/or atelectasis documented by Chest X-Ray) through clinical observations throughout the postoperative period 3. Chest tube duration is measured as the number of days from operation to the removal of the last chest tube 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	—

Measure

Time frame

1. Gas exchange improvement is measured using systemic arterial blood gas analysis at baseline, 1 and 4 days postoperatively 2. Post-operative complications are measured (in particular pneumonia and/or atelectasis documented by Chest X-Ray) through clinical observations throughout the postoperative period 3. Chest tube duration is measured as the number of days from operation to the removal of the last chest tube 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

—

Countries

Italy

Contacts

Public ContactMario Nosotti

mario.nosotti@unimi.it+39 02 5503 5570

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026