Clinical Trials Directory

Trials / Recruiting

RecruitingNCT05630443

Effects of Prone Position After Major Abdominal Surgery

Status
Recruiting
Phase
N/A
Study type
Interventional
Enrollment
200 (estimated)
Sponsor
Vastra Gotaland Region · Other Government
Sex
All
Age
Healthy volunteers
Not accepted

Summary

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.

Detailed description

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. The patients will be randomized to the standard ERAS-protocol, enhanced recovery after surgery with or without adding periods of prone position after surgery. They will be followed by protocol both as a momentum effect (experimental study) on POD 2-5 and also POD 7. The aim is evaluation of prone position in order to improve the ventilation and hopefully diminish the risk of for example pneumonia and thromboembolism. Inclusion criteria Patients referred to the Department of Surgery for major abdominal surgery of the esophagus, gastric- or pancreas surgery aim to cure. Exclusion criteria Patients unable to understand Swedish in writing or speaking, preoperatively unable to perform a prone position. The participation is voluntary and demands an inform consent from the patient operated upon. The primary outcome is oxygen saturation and lung complications after surgery. The secondary outcome is measurement of lung volumes, patient experience (7th graded Lickert scale), days of hospital care, 30 days complications etc. Further investigations are perioperative properties as BMI, other forms of surgery, etc., and continues measurement of blood pressure, respiration frequency, heartrate, tubes and drainages, postoperative analgesic, blood samples with signs of bleeding, inflammation, infection.

Conditions

Interventions

TypeNameDescription
PROCEDUREprone positionOrdinary ERAS treatment postoperatvely adding the prone position and voicetraining

Timeline

Start date
2022-10-01
Primary completion
2026-12-31
Completion
2026-12-31
First posted
2022-11-29
Last updated
2024-05-30

Locations

1 site across 1 country: Sweden

Source: ClinicalTrials.gov record NCT05630443. Inclusion in this directory is not an endorsement.