Condition category
Surgery
Date applied
30/01/2011
Date assigned
01/06/2011
Last edited
01/06/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Mª Carmen Unzueta

ORCID ID

Contact details

Department of Anaesthesia
Hospital de Sant Pau
Barcelona
08025
Spain

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

Sponsor information

Organisation

Hospital de Sant Pau (Spain)

Sponsor details

San Antonio Mª Claret 165
Barcelona
08025
Spain

Sponsor type

Hospital/treatment centre

Website

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

Publication citations

Additional files

Editorial Notes