Vital sign monitoring with continuous pulse oximetry and wireless clinical notification after surgery (the VIGILANCE pilot study)—a randomized controlled pilot trial
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Résumé
BACKGROUND: falls below a set threshold, the clinician is notified via a pager and may intervene earlier to prevent further clinical deterioration. To date, the technology has not been evaluated with a randomized controlled trial (RCT). METHODS: We designed a parallel-group unblinded pilot RCT of a wireless monitoring system on two surgical wards in an academic teaching hospital. Postsurgical patients with an anticipated length of stay of at least 1 day were included and randomized to standard care or standard care plus wireless respiratory monitoring for up to a 72-h period. The primary outcomes were feasibility outcomes: average patients recruited per week and tolerability of the system by patients. Secondary outcomes included (1) respiratory events (naloxone administration for respiratory depression, ICU transfers, and cardiac arrest team activation) and (2) system alarm types and details. The analysis of the outcomes was based on descriptive statistics and estimates reported using point (95% confidence intervals). Criteria for success of feasibility were recruitment of an average of 15 patients/week and 90% of the patients tolerating the system. RESULTS: The pilot trial enrolled 250 of the 335 patients screened for eligibility, with 126 and 124 patients entering the standard monitoring and wireless groups, respectively. Baseline demographics were similar between groups, except for slightly more women in the wireless group. Average patient recruitment per week was 14 95% CI [12, 16] patients. The wireless monitoring was quite tolerable with 86.6% (95% CI 78.2-92.7%) of patients completing the full course, and there were no other adverse events directly attributable to the monitoring. With regard to secondary outcomes, the respiratory event rate was low with only 1 event in the wireless group and none in the control group. The average number of alarms per week was 4.0 (95% CI, 1.6-6.4). CONCLUSIONS: This pilot study demonstrated adequate patient recruitment and high tolerability of the wireless monitoring system. A full RCT that is powered to detect patient important outcomes such as respiratory depression is now underway. TRIAL REGISTRATION: ClinicalTrials.gov, Registration number NCT02907255, registered 7 September 2016-retrospectively registered.
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Prédiction distillée sur la base complète
Imitation des enseignantsNi prévalence calibrée, ni vérité terrain. Validation humaine à venir. Apprise à partir de 10 348 étiquettes directes de Codex et de 10 348 étiquettes directes de Gemma. Le mode candidate est l'union des têtes enseignantes seuillées; le consensus est leur intersection. Ces sorties portent le statut machine_predicted_unvalidated et ne sont ni des étiquettes humaines ni des étiquettes directes de modèles de pointe.
Scores Codex et Gemma par catégorie
| Catégorie | Codex | Gemma |
|---|---|---|
| Métarecherche | 0,004 | 0,001 |
| Méta-épidémiologie (sens strict) | 0,001 | 0,000 |
| Méta-épidémiologie (sens large) | 0,003 | 0,000 |
| Bibliométrie | 0,000 | 0,000 |
| Études des sciences et des technologies | 0,000 | 0,000 |
| Communication savante | 0,000 | 0,000 |
| Science ouverte | 0,000 | 0,000 |
| Intégrité de la recherche | 0,000 | 0,000 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,000 | 0,000 |
Scores machine (provisoires)
Les deux têtes enseignantes du modèle étudiant, lues sur ce travail. Un score ordonne la base pour la relecture; il n'affirme jamais une catégorie, et le statut de validation accompagne chaque rangée tel quel.
Scores de référence d'un modèle non mature (critères de maturité non atteints, 7 itérations). Un score ordonne; il n'affirme jamais une catégorie.
score_only:v0-immature-baseline · tel quel depuis la passe de notation : score_only signifie que le nombre peut ordonner les travaux, et qu'aucune étiquette de catégorie n'en découle