Trial · NCT07887256
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Proportion successfully maintained monitor | From day of surgery (day 0) until day 3 postoperative | The proportion of patients (%) in whom continuous tissue oximetry monitoring was successfully maintained for the entire postoperative period. |
| Secondary | Surgical re-exploration | From day of surgery (day 0) until day 3 postoperative | Surgical re-exploration performed because of suspected vascular compromise of the free flap. Yes/no. |
| Secondary | Flap failure | From day of surgery (day 0) until day 3 postoperative | Flap failure. Yes/no. |
| Secondary | Flap risk score | From day of surgery (day 0) until day 3 posteroperative | 0= no risk parameters present 6= all risk parameters present. Risk parameters are: color, consistency, capillary refill, temperature, doppler signal, clinical suspiscion. Parameters score 0 if the parameter is clinically judged to be normal/optimal and 1 if parameter is clinically judged to be suboptimal |
| Secondary | Postoperative complications | From day of surgery (day 0) until day 3 posteroperative | According to Clavien-Dindo scale Grade I Any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic and radiological interventions. Allowed therapeutic regimens are: drugs as antiemetics, antipyretics, analgetics, diuretics and electrolytes and physiotherapy. This grade also includes wound infections opened at the bedside. Grade II Requiring pharmacological treatment with drugs other than such allowed for grade I complications. Blood transfusionsand total parenteral nutritionare also included. Grade III Requiring surgical, endoscopic or radiological intervention * IIIa Intervention not under general anesthesia * IIIb Intervention under general anesthesia Grade IV Life-threatening complication (including CNS complications)\* requiring IC/ICU-management * IVa single organ dysfunction (including dialysis) * IVb multiorgandysfunction Grade V Death of a patient |
| Secondary | INVOS risk triggers: absolute drop of StO₂ | From start of INVOS measurements (day 0) until day 3 postoperative | Number of absolute drops of StO₂ \< 60%. |
| Secondary | INVOS risk triggers: relative drop StO₂ | From start of INVOS measurements (day 0) until day 3 postoperative | Number of relative drops of StO₂ ≥20% decrease from baseline sustained ≥30 minutes. |
| Secondary | INVOS risk triggers: flap-to-reference ratio | From start of INVOS measurements (day 0) until day 3 postoperative | Flap-to-reference ratio of \<0.75. Yes/no |
| Secondary | Incidence sensor displacement or detachment | From day of surgery (day 0) until day 3 posteroperative | The incidence of mechanical sensor displacement or complete detachment requiring clinical intervention or sensor replacement within the first 48 hours postoperatively. |
| Secondary | Cumulative duration missing StO2 data | From start INVOS measurement (day 0) until day 3 postoperative | The cumulative duration of missing or uninterpretable tissue oxygen saturation (StO₂) data due to sensor detachment, signal artifacts, or hardware failure, expressed as a percentage (%) of the total monitoring time. |
| Other | Reasons of device failure | From day of surgery (day 0) until day 3 postoperative | Reasons of device failure. For each case, the reason why the device failed or did not function as intended (e.g. technical malfunction, battery issue, software error, or user error) is recorded as free text. This is a qualitative outcome measure with no unit. Responses will be described and categorised afterwards to identify the most frequent causes of failure. |
| Other | Patient satisfaction | At day 3 postoperative | At the end of the monitoring period (72h) the patient will be asked to rate their experience with the INVOS monitoring by answering the following questions: * Express your satisfaction with INVOS monitoring (0-5; 0 very dissatisfied - 5 very satisfied) * Did INVOS interfere with mobility? (0-5; 0 not at all - 5 very much) * Did INVOS interfere with sleep? (0-5; 0 not at all - 5 very much) * Did INVOS monitoring make you feel more reassured? (0-5; 0 not at all - 5 very much): * Would you be willing to receive INVOS monitoring for potential future postoperative monitoring? (yes/maybe/no) * Would you recommend INVOS monitoring for postoperative monitoring to other patients? (yes/maybe/no) |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT07887256/registered