Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Alveolar recruitment strategy improves lung function during thoracic surgery: a prospective, randomised study
Acronym
Study hypothesis
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
Hospital de Sant Pau Research Ethics Committee approved on the 19th December 2007
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measures
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 trial start date
07/01/2009
Overall trial end date
01/04/2011
Reason abandoned
Eligibility
Participant inclusion criteria
Elective adults patients undergoing open thoracic surgery in lateral position requiring one-lung ventilation lasting longer than 40 minutes
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
40 (20 per group)
Participant exclusion criteria
Previous contralateral lobectomy, uncompensated cardiac disease, arrhythmias with hemodynamic repercussions, severe air trapping (residual volume > 150%) and presence of large bullae
Recruitment start date
07/01/2009
Recruitment end date
01/04/2011
Locations
Countries of recruitment
Spain
Trial participating centre
Department of Anaesthesia
Barcelona
08025
Spain
Funders
Funder type
Hospital/treatment centre
Funder name
Hospital de Sant Pau (Spain)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary