Postoperative monitoring of respiratory function

Continuous wireless monitoring of postoperative patients on the surgical ward: a pilot study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON28102

Enrollment

100

Registered

2016-01-13

Start date

2016-01-25

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

(acoustic) respiratory rate (RRa), heart rate (HR), saturation, pulse oximetry (akoestische) ademhalingsfrequentie, hartslag, saturatie

Interventions

Postoperative 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, hear

Eligibility

Inclusion criteria

Inclusion criteria: Postoperative 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

Exclusion criteria: <18 years old, not speaking Dutch or English, ARISCAT score < 26

Design outcomes

Primary

Measure	Time frame
•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

Measure	Time frame
• 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	—

Measure

Time frame

• 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

—

Contacts

Public ContactHugo R.W. Touw

Vrije Universiteit medical center (VUmc) De Boelelaan 1117, office number 5F 26, 1081 HV Amsterdam

h.touw@vumc.nl

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)