Background:
There is a lack of studies regarding Optimal (best) positive end-expiratory pressure (PEEP) in prone position during surgery, and its relation with optimal PEEP in supine position.
Hypothesis:
In patients undergoing scheduled spinal surgery, optimal PEEP in the prone position is lower than optimal PEEP in the supine position.
Aims:
To assess the difference optimal PEEP in supine vs. prone positions in patients undergoing spine surgery.
To evaluate the changes in optimal PEEP in prone position throughout the surgical procedure.
Methods:
Observational study, one center. Main variable: optimal PEEP. Secondary variables: PaO2, pCO2 and dynamic compliance (Crd) in prone and supine position.
Condition or disease | Intervention/treatment |
---|---|
Anesthesia Surgery | Other: Evaluation of PEEP in prone position |
Study Type : | Observational |
Estimated Enrollment : | 20 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Optimal Positive End-expiratory Pressure (PEEP) in Prone Position During Spine Surgery. A Prospective Observational Study |
Estimated Study Start Date : | September 2019 |
Estimated Primary Completion Date : | September 2020 |
Estimated Study Completion Date : | September 2020 |
Tracking Information | |||||
---|---|---|---|---|---|
First Submitted Date | June 27, 2019 | ||||
First Posted Date | July 18, 2019 | ||||
Last Update Posted Date | July 24, 2019 | ||||
Estimated Study Start Date | September 2019 | ||||
Estimated Primary Completion Date | September 2020 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures |
|
||||
Original Primary Outcome Measures | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures |
|
||||
Original Secondary Outcome Measures | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title | Optimal Positive End-expiratory Pressure (PEEP) in Prone Position During Spine Surgery | ||||
Official Title | Optimal Positive End-expiratory Pressure (PEEP) in Prone Position During Spine Surgery. A Prospective Observational Study | ||||
Brief Summary |
Background: There is a lack of studies regarding Optimal (best) positive end-expiratory pressure (PEEP) in prone position during surgery, and its relation with optimal PEEP in supine position. Hypothesis: In patients undergoing scheduled spinal surgery, optimal PEEP in the prone position is lower than optimal PEEP in the supine position. Aims: To assess the difference optimal PEEP in supine vs. prone positions in patients undergoing spine surgery. To evaluate the changes in optimal PEEP in prone position throughout the surgical procedure. Methods: Observational study, one center. Main variable: optimal PEEP. Secondary variables: PaO2, pCO2 and dynamic compliance (Crd) in prone and supine position. |
||||
Detailed Description | Not Provided | ||||
Study Type | Observational | ||||
Study Design | Observational Model: Cohort Time Perspective: Prospective |
||||
Target Follow-Up Duration | Not Provided | ||||
Biospecimen | Not Provided | ||||
Sampling Method | Non-Probability Sample | ||||
Study Population | Patients scheduled for spine surgery that requires prone decubitus. | ||||
Condition |
|
||||
Intervention | Other: Evaluation of PEEP in prone position
Assessment of optimal Positive End-Expiratory Pressure (PEEP) in patients undergoing scheduled spine surgery in prone position.
|
||||
Study Groups/Cohorts | Not Provided | ||||
Publications * |
|
||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
Recruitment Information | |||||
Recruitment Status | Unknown status | ||||
Estimated Enrollment |
20 | ||||
Original Estimated Enrollment | Same as current | ||||
Estimated Study Completion Date | September 2020 | ||||
Estimated Primary Completion Date | September 2020 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
|
||||
Sex/Gender |
|
||||
Ages | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers | No | ||||
Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries | Spain | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number | NCT04024410 | ||||
Other Study ID Numbers | 2018/8270/I | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
|
||||
IPD Sharing Statement |
|
||||
Responsible Party | Parc de Salut Mar | ||||
Study Sponsor | Parc de Salut Mar | ||||
Collaborators | Not Provided | ||||
Investigators |
|
||||
PRS Account | Parc de Salut Mar | ||||
Verification Date | June 2019 |