Ignite Creation Date:
2024-05-06 @ 10:48 AM
Last Modification Date:
2024-10-26 @ 12:35 PM
Study NCT ID:
NCT03356496
Status:
WITHDRAWN
Last Update Posted:
2022-08-29
First Post:
2017-11-09
Brief Title:
Preoperative Self-managed Respiratory Therapy for Reduction of Postoperative Pulmonary Complications
Sponsor:
Medical College of Wisconsin
Organization:
Medical College of Wisconsin
Study Overview
Official Title:
Preoperative Self-managed Respiratory Therapy for Reduction of Postoperative Pulmonary Complications After Non-cardiothoracic Surgery
Status:
WITHDRAWN
Status Verified Date:
2022-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Delays due to COVID standard of care has changed eliminating the need for the study
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PRESMART
Brief Summary:
Postoperative pulmonary complications PPCs are a source of much morbidity and mortality Rates of PPCs exceed 30 in patients with multiple risk factors Several studies have demonstrated reduced PPCs in patients who underwent preoperative inspiratory muscle training These studies largely focused on cardiothoracic surgery and required the use of respiratory therapists The investigators hypothesize that preoperative self-administered respiratory therapy would reduce PPCs in patients with risk factors for PPCs undergoing any non-cardiothoracic surgery This study is a randomized controlled trial comparing preoperative use of an incentive spirometry device with usual care in patients undergoing non-emergent non-cardiothoracic surgical procedures under general anesthesia
Detailed Description:
Postoperative pulmonary complications account for 50 of all adverse postoperative events and are more costly and carry greater comorbidity than cardiac complications Much research has been performed to identify potential risk reduction strategies for PPCs Until recently all of these focused on intraoperative and postoperative interventions including lung-protective mechanical ventilation lung expansion techniques and use of regional anesthesia and analgesia In the last few years several studies have investigated the potential role of preoperative interventions to improve respiratory status These studies have demonstrated benefit from preoperative inspiratory muscle training IMT A recent systematic review found that any preoperative intervention such as education IMT exercise training or relaxation reduced PPC rates However these studies have focused on cardiothoracic and abdominal surgery and almost all have utilized respiratory therapist-directed interventions Likely due to the additional costs and difficulty of arranging respiratory therapy on an outpatient basis this promising new risk mitigation strategy has yet to be adopted on a large scale Incentive spirometry devices offer a potentially easier and less costly preoperative respiratory intervention Incentive spirometers are a drug-free easy to use hand-held device that promotes deep breathing and respiratory muscle strength by providing visual feedback during sustained inhalation It opens weak or collapsed airways to mobilize and assist mucociliary clearance to the upper airways where it can be coughed out This study evaluates the hypothesis that providing preoperative patient self-directed respiratory therapy with use of an incentive spirometry device will reduce the incidence of PPCs in patients with increased pulmonary risk undergoing any major non-cardiothoracic surgery with general anesthesia
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None