Clinical trial NCT03356496: Preoperative Self-managed Respiratory Therapy for Reduction of Postoperative Pulmonary Complications
Official title: Preoperative Self-managed Respiratory Therapy for Reduction of Postoperative Pulmonary Complications After Non-cardiothoracic Surgery
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Postoperative Respiratory Complication
Lead sponsor: Medical College of Wisconsin
Sponsor class: OTHER
First posted: 2017-11-29
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Postoperative pulmonary complications
timeFrame: Up to 30 days after surgery
Secondary outcomes:
measure: Mortality
timeFrame: Up to 30 days after surgery
measure: Length-of-stay
timeFrame: Up to 30 days after surgery
measure: Readmission
timeFrame: Up to 30 days after surgery
measure: Unanticipated hospital admissions
timeFrame: Up to 30 days after surgery
measure: Unanticipated hospital observation
timeFrame: Up to 30 days after surgery
measure: Unanticipated intensive care unit utilization
timeFrame: Up to 30 days after surgery
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Froedtert Hospital
state: Wisconsin
Study officials:
References:
citation: Canet J, Gallart L, Gomar C, Paluzie G, Valles J, Castillo J, Sabate 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.
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;2015(10):CD010356. doi: 10.1002/14651858.CD010356.pub2.