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

NCT ID: NCT03356496

Last Updated: 2022-08-29

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-22
• Study Completion Date: 2021-05-27

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.

Conditions

Postoperative Respiratory Complication

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

AirLife 4000 cc incentive spirometry device

Intervention Type: DEVICE

Incentive spirometry device provides improved lung expansion and respiratory muscle strength

Control

Patient receives only usual care as provided by perioperative healthcare providers.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

AirLife 4000 cc incentive spirometry device

Incentive spirometry device provides improved lung expansion and respiratory muscle strength

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical College of Wisconsin

OTHER

Sponsor Role: lead

Responsible Party

Hari Paudel

Assistant Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Froedtert Hospital

Milwaukee, Wisconsin, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 21045639 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26436600 (View on PubMed)

Other Identifiers

PRO00030057

Identifier Type: -

Identifier Source: org_study_id