Postoperative Respiratory Complication Clinical Trial
— PRESMARTOfficial title:
Preoperative Self-managed Respiratory Therapy for Reduction of Postoperative Pulmonary Complications After Non-cardiothoracic Surgery
Verified date | August 2022 |
Source | Medical College of Wisconsin |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | May 27, 2021 |
Est. primary completion date | May 27, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Intermediate or high risk for postoperative pulmonary complications as defined by ARISCAT score >25 - Undergoing non-cardiothoracic surgery scheduled at least 7 days in the future - Planned general anesthesia (alone or in combination with regional or neuraxial anesthesia) - Personal internet access Exclusion Criteria: - Active bronchospasm during preoperative clinic visit - History of pneumothorax - History of tracheal stoma or ventilator dependency - Pregnancy - Chronic oxygen requirement - Deficient motor and/or visual function that will prohibit utilization of the device or instructional video and handout - Lack of English language proficiency - Inability to consent |
Country | Name | City | State |
---|---|---|---|
United States | Froedtert Hospital | Milwaukee | Wisconsin |
Lead Sponsor | Collaborator |
---|---|
Medical College of Wisconsin |
United States,
Canet J, Gallart L, Gomar C, Paluzie G, Vallès J, Castillo J, Sabaté S, Mazo V, Briones Z, Sanchis J; ARISCAT Group. Prediction of postoperative pulmonary complications in a population-based surgical cohort. Anesthesiology. 2010 Dec;113(6):1338-50. doi: 10.1097/ALN.0b013e3181fc6e0a. — View Citation
Katsura M, Kuriyama A, Takeshima T, Fukuhara S, Furukawa TA. Preoperative inspiratory muscle training for postoperative pulmonary complications in adults undergoing cardiac and major abdominal surgery. Cochrane Database Syst Rev. 2015 Oct 5;(10):CD010356. doi: 10.1002/14651858.CD010356.pub2. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Postoperative pulmonary complications | Composite of hypoxemia (pulse oximetry <88% with provision of oxygen therapy beyond 24 hours after surgery); bronchospasm (new wheezing or bronchospasm with provision of bronchodilator therapy); hypercarbia (serum bicarbonate or arterial or end-tidal carbon dioxide level above reference range treated with provision of mechanical ventilation); atelectasis (radiographic evidence of atelectasis plus respiratory symptoms or abnormal lung exam findings); respiratory infection (patient received antibiotics for suspected respiratory infection and had at least 1 of following: new or changed sputum, new or changed lung opacities on chest radiograph, fever, or leukocyte count >12,000/microliter); pleural effusion (radiographic evidence of pleural effusion and performance of thoracentesis); pneumothorax (radiographic evidence of pneumothorax); and ventilatory failure (replacement of endotracheal tube or mechanical ventilation for >48 hours postoperatively) | Up to 30 days after surgery | |
Secondary | Mortality | Patient death from any cause | Up to 30 days after surgery | |
Secondary | Length-of-stay | Number of days of hospitalization after index surgery | Up to 30 days after surgery | |
Secondary | Readmission | Incidence of rehospitalization after index surgery | Up to 30 days after surgery | |
Secondary | Unanticipated hospital admissions | Incidence of inpatient admission after index surgery that was planned as outpatient | Up to 30 days after surgery | |
Secondary | Unanticipated hospital observation | Incidence of admission for observation for recovery after index surgery planned as outpatient | Up to 30 days after surgery | |
Secondary | Unanticipated intensive care unit utilization | Incidence of intensive care admission after index surgery not planned for intensive care unit admission | Up to 30 days after surgery |
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