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

NCT03356496 | Withdrawn FDA Device

• 1 other identifier: PRO00030057
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Respiratory Complication

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Mortality

  Up to 30 days after surgery

• Length-of-stay

  Up to 30 days after surgery

• Readmission

  Up to 30 days after surgery

• Unanticipated hospital admissions

  Up to 30 days after surgery

• Unanticipated hospital observation

  Up to 30 days after surgery

Study Arms (2)

Intervention

EXPERIMENTAL

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

Control

NO INTERVENTION

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

Interventions

AirLife 4000 cc incentive spirometry device DEVICE

Incentive spirometry device provides improved lung expansion and respiratory muscle strength

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical College of Wisconsin: lead

Study Sites (1)

Froedtert Hospital

Milwaukee, Wisconsin, 53226, United States

Location

Related Publications (2)

• 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.

  PMID: 21045639 BACKGROUND

• 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.

  PMID: 26436600 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: November 9, 2017
• First Posted: November 29, 2017
• Study Start: January 22, 2020
• Primary Completion: May 27, 2021
• Study Completion: May 27, 2021
• Last Updated: August 29, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)