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
Protocol serial number	N/A
Sponsor	Hospital de Sant Pau (Spain)
Funder	Hospital de Sant Pau (Spain)

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

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant 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(s)	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
Key secondary outcome measure(s)	No secondary outcome measures
Completion date	01/04/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	40
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

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes