Preoperative Self-managed Respiratory Therapy for Reduction of Postoperative Pulmonary Complications

Postoperative Respiratory Complication Clinical Trial

— PRESMART  

Official title:

Preoperative Self-managed Respiratory Therapy for Reduction of Postoperative Pulmonary Complications After Non-cardiothoracic Surgery

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03356496
• Other study ID #: PRO00030057
• Status: Withdrawn
• Phase: N/A
• Start date: January 22, 2020
• Est. completion date: May 27, 2021

Study information

• Verified date: August 2022
• Source: Medical College of Wisconsin
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Postoperative Respiratory Complication

Intervention

Device:
• AirLife 4000 cc incentive spirometry device
Incentive spirometry device provides improved lung expansion and respiratory muscle strength

Locations

Country	Name	City	State
United States	Froedtert Hospital	Milwaukee	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Medical College of Wisconsin

Country where clinical trial is conducted

United States, 

References & Publications (2)

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

Outcome

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