Effects of Prone Position After Major Abdominal Surgery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorVastra Gotaland Region
About this trial
Evaluation of postoperative prone position after major abdominal surgery. A randomized clinical trial of 100+100 patients and further add a voice/speech/singing protocol.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Sequential
Treatments tested in this trial
prone position
Procedure/SurgeryOrdinary ERAS treatment postoperatvely adding the prone position and voicetraining
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: ERASNo intervention 0 interventions
Group B: +prone positionActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Oxygen saturation measurement postoperatively
Measurement during sitting position
Time frame
an average of (POD) Postoperative day 2-72
Number of participants with treatment-related adverse events of postoperative lung and abdominal complications incl a CT scan for objective measurement
Adverse events like pneumonia, lungembolism, lungempyema, interventions pankreatitis
Time frame
through study completion, an average of 1 year3
Number of participants with treatment-related adverse events of postoperative lung and abdominal complications
Pneumonia, Lung embolism, Empyema of the lung, pankreatitis
Time frame
through study completion, an average of 1 yearSecondary outcomes
1
Number of participants with treatment-related diminished lung volumes
Spirometric measurements of diminished lung volumes
Time frame
through study completion, an average of 1 year2
Number of days of Hospital care
Days of inhouse treatment
Time frame
through study completion, an average of 1 year3
Number of participants needing intervention
Treament intervention like antibiotics or other medical or interventional treatment
Time frame
through study completion, an average of 1 yearSponsors and contacts
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Source ClinicalTrials.gov