The effect of Continuous Positive Airway Pressure (CPAP) on the collapsed lung during single-lung-ventilation in patients undergoing robot-assisted thoracoscopic esophageal resection: pulmonary complications, local and systemic cytokine production
| ISRCTN | ISRCTN61458115 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN61458115 |
| Protocol serial number | N/A |
| Sponsor | University Medical Center Utrecht (UMCU), Department of Surgery (The Netherlands) |
| Funder | Comprehensive Cancer Centre (Integraal Kankercentrum) |
- Submission date
- 28/04/2006
- Registration date
- 28/04/2006
- Last edited
- 28/04/2006
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
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 R. Hillegersberg, van
Scientific
Scientific
University Medical Center Utrecht (UMCU)
Department of Surgery, G04.228
Heidelberglaan 100
Utrecht
3584 CX
Netherlands
| Phone | +31 (0)30 2506968 |
|---|---|
| r.vanhillegersberg@umcutrecht.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study acronym | COCTAIL |
| Study objectives | Continuous positive airway pressure on the deflated lung prevents total alveolar collapse, resulting in less local and systemic cytokine response, causing less pulmonary complications. |
| Ethics approval(s) | Ethics approval received from the local medical ethics committee |
| Health condition(s) or problem(s) studied | Esophageal cancer |
| Intervention | Continuous Positive Airway Pressure (CPAP) to the collapsed lung during single-lung-ventilation versus no CPAP. |
| Intervention type | Other |
| Primary outcome measure(s) |
Local and systemic cytokine production. |
| Key secondary outcome measure(s) |
1. Pulmonary complications |
| Completion date | 05/04/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 30 |
| Key inclusion criteria | 1. Patients with resectable carcinoma of the esophagus or junction that will undergo robot-assisted thoracoscopic esophago-lymphadenectomy with gastric conduit formation 2. American Society of Anesthesiologists (ASA) classification <4 3. Written informed consent |
| Key exclusion criteria | 1. Moderate/severe lung function impairment ascertained by pulmonary function tests, requiring high dose steroid therapy 2. No epidural catheter |
| Date of first enrolment | 05/04/2006 |
| Date of final enrolment | 05/04/2008 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
University Medical Center Utrecht (UMCU)
Utrecht
3584 CX
Netherlands
3584 CX
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
