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Postoperative monitoring of respiratory function


- candidate number23606
- NTR NumberNTR5650
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR13-jan-2016
- Secondary IDs2015/496 METc VU medisch centrum
- Public TitlePostoperative monitoring of respiratory function
- Scientific TitleContinuous wireless monitoring of postoperative patients on the surgical ward: a pilot study
- ACRONYMPulMONIC
- hypothesisIn this pilot study we aim to determine the course of vital patient parameters in the postoperative period using Masimo remote monitoring, in particular the incidence and severity of postoperative hypoxemia and changes in respiratory rate. Our hypothesis is that the incidence of hypoxemia or a respiratory rate ≤9 breaths per minute (brpm) or RR ≥15 brpm and RR ≥21 brpm above 20 breaths per minute in the postoperative period is significant in patients admitted to a general surgical ward, and adequate monitoring may prevent deterioration of the health condition of these patients as it allows early interventions.
- Healt Condition(s) or Problem(s) studiedRespiratory rate , Heart rate , Saturation
- Inclusion criteriaPostoperative patients after upper abdominal surgery (eg esophagus-, liver- and pancreas surgery), >18 years old, speaking Dutch or English, with a preoperative determined moderate or high risk of development of postoperative pulmonary complications based on the ARISCAT score of 26 or higher.
- Exclusion criteria<18 years old, not speaking Dutch or English, ARISCAT score < 26
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeobservational
- planned startdate 25-jan-2016
- planned closingdate31-jan-2017
- Target number of participants100
- InterventionsPostoperative patients after gastro-intestinal surgery (esophagus-, liver- and pancreas surgery) will be monitored the first 4 post-operative days on the surgical ward. Patient vital parameters, heart rate, pulse oxymetry, acoustic respiratory rate will be monitored by a remote wireless monitor, Radius 7 (Masimo) worn on an arm that is connected to an adhesive sensor in the patients’ neck and a probe on the index finger. Data is collected , downloaded and securely stored with a direct cable connection to the root on a daily basis. The data are collected on the root with a secured Bluetooth connection with the remote monitor. These data will be compared with the data that are retrieved from the electronic medical patient file.
- Primary outcome• Number of hypoxemic events (SpO2<92%) in the postoperative setting on day 1-4 following surgery
• Number of episodes of aberrant respiratory rates (RR ≤9 brpm or RR ≥15 brpm and RR ≥21 brpm) according to the the MEWS criteria (see attachment)
- Secondary outcome• Suspected pulmonary infection (Treatment with antibiotics for a respiratory infection, plus at least one of the following criteria: New or changed sputum, New or changed lung opacities on a clinically indicated chest radiograph, temperature >38.3°C, leukocyte count >12,000/mm3, pleural effusion or chest radiograph demonstrating blunting of the costophrenic angle, loss of the sharp silhouette of the ipsilateral hemidiaphragm.
• Atelectasis (Suggested by lung opacification with shift of the mediastinum, hilum, or hemidiaphragm toward the affected area, and compensatory overinflation in the adjacent nonatelectatic lung).
• Pneumothorax (Air in the pleural space with no vascular bed surrounding the visceral pleura) Bronchospasm Newly detected expiratory wheezing treated with bronchodilators.
• Postoperative pain (visual analogue scale of 4 or higher)
• Fever (body temperature of 38C or higher)
• General infection requiring antibiotics use
• Device failure
- TimepointsPostoperative patients will be monitored for four days. Pulse oximetry and heart rate data will be converted to a per minute value. The respiratory rate date will be converted to a per 30 second value to be able accurately register respiratory depression or respiratory failure.
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIESMD Hugo R.W. Touw
- CONTACT for SCIENTIFIC QUERIESMD Hugo R.W. Touw
- Sponsor/Initiator VU University Medical Center
- Funding
(Source(s) of Monetary or Material Support)
Masimo Corporation
- Publications
- Brief summaryIn this pilot study we aim to evaluate the number of patients that develop respiratory dysfunction in the postoperative period, and whether respiratory dysfunction can be related to the development of postoperative complications.
- Main changes (audit trail)
- RECORD13-jan-2016 - 12-mrt-2016


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