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 |
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| Original Primary Outcome Measures | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures |
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| 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. |
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| Detailed Description | Not Provided | ||||
| Study Type | Observational | ||||
| Study Design | Observational Model: Cohort Time Perspective: Prospective |
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| 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 |
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| 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.
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| Study Groups/Cohorts | Not Provided | ||||
| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| 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:
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| Sex/Gender |
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| 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 |
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| IPD Sharing Statement |
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| Responsible Party | Parc de Salut Mar | ||||
| Study Sponsor | Parc de Salut Mar | ||||
| Collaborators | Not Provided | ||||
| Investigators |
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| PRS Account | Parc de Salut Mar | ||||
| Verification Date | June 2019 | ||||