Use of Integrated Pulmonary Index to Predict Post-Operative Respiratory Adverse Events in High Risk Patients

JRCT ID: jRCTs062180014

Registered date:04/01/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: High risk patients undergoing general anesthesia
• Date of first enrollment: 14/03/2019
• Target sample size: 200
• Countries of recruitment: United States,Japan
• Study type: Interventional
• Intervention(s): The care team and patient will be blinded to the Capnostream 20p monitor's data for the patient's entire PACU/ICU stay or 2 hours, whichever is shorter.

Outcome(s)

Primary Outcome

Respiratory events/interventions logged:
-Increase in oxygen delivery method (such as nasal cannula to high flow nasal cannula or non-rebreather, etc.)
-Respiratory treatment (including albuterol, atrovent or racemic epinephrine)
-Initiation of BiPap or intubation/mechanical ventilation
-Administration of naloxone or flumazenil
-Desaturation - defined as pulse oximetry below 90% sustained for greater than 2 minutes
-Hypercarbia - defined as PaCO2 (from ABG) >50mmHg
-Respiratory rate <8 breaths per minute
-Administration of any dose of atropine or epinephrine
-Other (specify)

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

Patients 18 years or older undergoing general anesthesia for one of following:
-craniotomy
-open upper abdominal surgery (including bariatric)
-vascular surgery (including open aortic surgery and lower extremity bypass surgery)
-surgical repair of hip fracture if patient has any of the following: albumin <30 g/L, BUN > 30 mg/dL, dependent functional status, COPD, age >75
-Posterior fusion (Lumbar or Thoracic)

Exclude criteria

-Pregnant
-Less than 18 years of age
-Mechanically ventilated prior to surgery

Related Information

• Primary Sponsor: Suzuki Satoshi
• Source(s) of Monetary Support: Covidien Japan Inc.