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

Department of Anaesthesia
Hospital de Sant Pau
Barcelona
08025
Spain

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleAlveolar recruitment strategy improves lung function during thoracic surgery: a prospective, randomised study
Study objectivesThe 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) studiedThoracic surgery
InterventionPatients 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 typeProcedure/Surgery
Primary outcome measure1. 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 measuresNo secondary outcome measures
Overall study start date07/01/2009
Completion date01/04/2011

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants40 (20 per group)
Key inclusion criteriaElective adults patients undergoing open thoracic surgery in lateral position requiring one-lung ventilation lasting longer than 40 minutes
Key exclusion criteriaPrevious contralateral lobectomy, uncompensated cardiac disease, arrhythmias with hemodynamic repercussions, severe air trapping (residual volume > 150%) and presence of large bullae
Date of first enrolment07/01/2009
Date of final enrolment01/04/2011

Locations

Countries of recruitment

  • Spain

Study participating centre

Department of Anaesthesia
Barcelona
08025
Spain

Sponsor information

Hospital de Sant Pau (Spain)
Hospital/treatment centre

San Antonio Mª Claret 165
Barcelona
08025
Spain

ROR logo "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 shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan