Study of the influence of a lung recruitment strategy on oxygenation, lung mechanics and dead-space in thoracic surgery
| ISRCTN | ISRCTN94238623 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN94238623 |
| Secondary identifying numbers | N/A |
- Submission date
- 30/01/2011
- Registration date
- 01/06/2011
- Last edited
- 01/06/2011
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Mª Carmen Unzueta
Scientific
Scientific
Department of Anaesthesia
Hospital de Sant Pau
Barcelona
08025
Spain
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Alveolar recruitment strategy improves lung function during thoracic surgery: a prospective, randomised study |
| Study objectives | The aim of the study is to investigate whether an alveolar recruitment strategy applied to both lungs before starting one lung ventilation (OLV) would improve gas exchange, lung mechanics and dead space |
| Ethics approval(s) | Hospital de Sant Pau Research Ethics Committee approved on the 19th December 2007 |
| Health condition(s) or problem(s) studied | Thoracic surgery |
| Intervention | Patients undergoing elective thoracotomy in the lateral position requiring one-lung ventilation and an arterial catheter were randomised to receive: 1. Lung recruitment manoeuvre with an inspiratory plateau pressure of 40cmH2O and PEEP of 20cmH2O was performed in this group for 10 consecutive breaths at the begining of both TLV periods 2. No lung recruitment |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | 1. Arterial blood gases 2. Volumetric capnography 3. Ventilatory and hemodynamic data These were recorded at the end of each one of the following study periods: 1. TLVbaseline: 5 min after placing the patient in the lateral position during TLV 2. TLV20: 20 min after placing the patient in the lateral position during TLV 3. OLV20: 20 min after OLV ventilation 4. OLV40: 40 min after OLV ventilation 5. TLVend: 10 min after re-establishing TLV once pulmonary resection was completed |
| Secondary outcome measures | No secondary outcome measures |
| Overall study start date | 07/01/2009 |
| Completion date | 01/04/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 40 (20 per group) |
| Key inclusion criteria | Elective adults patients undergoing open thoracic surgery in lateral position requiring one-lung ventilation lasting longer than 40 minutes |
| Key exclusion criteria | Previous contralateral lobectomy, uncompensated cardiac disease, arrhythmias with hemodynamic repercussions, severe air trapping (residual volume > 150%) and presence of large bullae |
| Date of first enrolment | 07/01/2009 |
| Date of final enrolment | 01/04/2011 |
Locations
Countries of recruitment
- Spain
Study participating centre
Department of Anaesthesia
Barcelona
08025
Spain
08025
Spain
Sponsor information
Hospital de Sant Pau (Spain)
Hospital/treatment centre
Hospital/treatment centre
San Antonio Mª Claret 165
Barcelona
08025
Spain
"ROR" |
https://ror.org/059n1d175 |
|---|
Funders
Funder type
Hospital/treatment centre
Hospital de Sant Pau (Spain)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
