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Incentive Spirometry Prehabilitation Study
Postoperative pulmonary complications (PPCs) are the most common complication following thoracic surgery. PPCs are associated with prolonged hospital stay, increased morbidity, mortality, ICU admission, and healthcare costs (Azhar, 2015). Current preoperative optimization in this patient group includes smoking cessation and management of Chronic Obstructive Pulmonary Disease with inhaled bronchodilators and inhaled steroids as indicated. There have been studies using preoperative incentive spirometry in patients undergoing laparotomy with conflicting results, but scant data on its use in patients undergoing one-lung ventilation (Tyson, et al., 2015; Cattano, et al., 2010). A study from 2013 investigated the effectiveness of incentive spirometry in patients following thoracotomy and found conflicting results, without significant improvement in lung function or reduction in PPCs, but a larger difference in frequency of PPC was noted, indicating possible benefit to intervention and a need for further study (Agostini, et al., 2013). Volume-based incentive spirometry pre- and postoperatively has also been found to improve pulmonary function and diaphragm excursion in patients undergoing laparoscopic surgery (Alaparthi, et al., 2016).
Patients customarily receive an incentive spirometer for use postoperatively in the PACU. There is scant data in the thoracic surgery population concerning prehabilitation by dispensing the incentive spirometer at the PACT evaluation.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Pulmonary Disease | Behavioral: Spirometry Group | Not Applicable |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 100 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Supportive Care |
| Official Title: | Pulmonary Prehabilitation With Incentive Spirometry in Patients Undergoing One-Lung Ventilation and the Effect on Postoperative Lung Function: A Randomized-Controlled Trial |
| Actual Study Start Date : | September 18, 2019 |
| Estimated Primary Completion Date : | September 1, 2021 |
| Estimated Study Completion Date : | September 1, 2022 |
| Arm | Intervention/treatment |
|---|---|
| No Intervention: Control | |
| Experimental: Spirometry Group |
Behavioral: Spirometry Group
Patients that are provided the incentive spirometer pre-operatively and instructed to use it for 4 cycles of 10 spirometry attempts on the day prior to surgery
|
- Lung Volumes [ Time Frame: From the time of admission to the pre-operative holding area to 72 hours post-operatively ]Mean Lung Volumes
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients scheduled for thoracic surgery procedures involving one-lung ventilation
- open thoracotomy
- Video-assisted thoracoscopic surgery (VATS)
- Robotic-assisted thoracoscopic surgery (RATS)
- Procedures to include: Lung resection for any purpose, esophagectomy, thymectomy
- Patients undergoing esophagectomy performed by a general surgeon
- Patients willing and able to independently perform incentive spirometry
Exclusion Criteria:
- Trauma patients
- Lung Volume reduction surgery (LVRS)
- In-Patients
- Patients not undergoing one-lung ventilation
- Patients undergoing thoracoabdominal aortic aneurysm repair
- Transhiatal esophagectomy (does not involve one-lung ventilation)
- Lung transplantation
| Contact: Adam B Sturdivant, MPH | 205-934-4042 | Adamsturdivant@uabmc.edu | |
| Contact: Ayesha Bryant, MD, MSPH | 205-996-7383 | Asbryant@uabmc.edu |
| United States, Alabama | |
| University of Alabama at Birmingham | Recruiting |
| Birmingham, Alabama, United States, 35233 | |
| Contact: Adam B Sturdivant, MPH 205-934-4042 Adamsturdivant@uabmc.edu | |
| Principal Investigator: Jeffrey Dobyns, DO | |
| Principal Investigator: | Jeffrey Dobyns, DO, MSHA | University of Alabama at Birmingham |
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | June 19, 2019 | ||||||||
| First Posted Date ICMJE | June 21, 2019 | ||||||||
| Last Update Posted Date | January 27, 2021 | ||||||||
| Actual Study Start Date ICMJE | September 18, 2019 | ||||||||
| Estimated Primary Completion Date | September 1, 2021 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Lung Volumes [ Time Frame: From the time of admission to the pre-operative holding area to 72 hours post-operatively ] Mean Lung Volumes
|
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | |||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Incentive Spirometry Prehabilitation Study | ||||||||
| Official Title ICMJE | Pulmonary Prehabilitation With Incentive Spirometry in Patients Undergoing One-Lung Ventilation and the Effect on Postoperative Lung Function: A Randomized-Controlled Trial | ||||||||
| Brief Summary |
Postoperative pulmonary complications (PPCs) are the most common complication following thoracic surgery. PPCs are associated with prolonged hospital stay, increased morbidity, mortality, ICU admission, and healthcare costs (Azhar, 2015). Current preoperative optimization in this patient group includes smoking cessation and management of Chronic Obstructive Pulmonary Disease with inhaled bronchodilators and inhaled steroids as indicated. There have been studies using preoperative incentive spirometry in patients undergoing laparotomy with conflicting results, but scant data on its use in patients undergoing one-lung ventilation (Tyson, et al., 2015; Cattano, et al., 2010). A study from 2013 investigated the effectiveness of incentive spirometry in patients following thoracotomy and found conflicting results, without significant improvement in lung function or reduction in PPCs, but a larger difference in frequency of PPC was noted, indicating possible benefit to intervention and a need for further study (Agostini, et al., 2013). Volume-based incentive spirometry pre- and postoperatively has also been found to improve pulmonary function and diaphragm excursion in patients undergoing laparoscopic surgery (Alaparthi, et al., 2016). Patients customarily receive an incentive spirometer for use postoperatively in the PACU. There is scant data in the thoracic surgery population concerning prehabilitation by dispensing the incentive spirometer at the PACT evaluation. |
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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase ICMJE | Not Applicable | ||||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Supportive Care |
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| Condition ICMJE | Pulmonary Disease | ||||||||
| Intervention ICMJE | Behavioral: Spirometry Group
Patients that are provided the incentive spirometer pre-operatively and instructed to use it for 4 cycles of 10 spirometry attempts on the day prior to surgery
|
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||||||
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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 ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE |
100 | ||||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||||
| Estimated Study Completion Date ICMJE | September 1, 2022 | ||||||||
| Estimated Primary Completion Date | September 1, 2021 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
|
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | United States | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT03994848 | ||||||||
| Other Study ID Numbers ICMJE | Spirometry | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Jeffry B. Dobyns, University of Alabama at Birmingham | ||||||||
| Study Sponsor ICMJE | University of Alabama at Birmingham | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| PRS Account | University of Alabama at Birmingham | ||||||||
| Verification Date | January 2021 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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