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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Postoperative Respiratory Complication
• Intervention / Treatment: Device: AirLife 4000 cc incentive spirometry device

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 Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Froedtert Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Intervention; Patient provided with instructions and video for the use of an incentive spirometry device. Patient instructed to use incentive spirometry device as frequently as every hour while awake but at least 4 times daily for at least 10 breathing cycles for 1-3 weeks before surgery. Patient instructed to record usage and any physical complaints in a diary.	Device: AirLife 4000 cc incentive spirometry device; Incentive spirometry device provides improved lung expansion and respiratory muscle strength
NO_INTERVENTION: Control; Patient receives only usual care as provided by perioperative healthcare providers.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality	Patient death from any cause	Up to 30 days after surgery
Length-of-stay	Number of days of hospitalization after index surgery	Up to 30 days after surgery
Readmission	Incidence of rehospitalization after index surgery	Up to 30 days after surgery
Unanticipated hospital admissions	Incidence of inpatient admission after index surgery that was planned as outpatient	Up to 30 days after surgery
Unanticipated hospital observation	Incidence of admission for observation for recovery after index surgery planned as outpatient	Up to 30 days after surgery
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

Collaborators and Investigators

• Sponsor: Medical College of Wisconsin

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 22, 2020
• Primary Completion (ACTUAL): May 27, 2021
• Study Completion (ACTUAL): May 27, 2021

Study Registration Dates

• First Submitted: November 9, 2017
• First Submitted That Met QC Criteria: November 28, 2017
• First Posted (ACTUAL): November 29, 2017

Study Record Updates

• Last Update Posted (ACTUAL): August 29, 2022
• Last Update Submitted That Met QC Criteria: August 25, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: PRO00030057

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes