Improvement of the pulmonary outcome for patients with upper abdominal surgery through preoperative breathing therapeutical training and Electric Impedance Tomography (EIT) as biofeedback

Improvement of the pulmonary outcome for patients with upper abdominal surgery through preoperative breathing therapeutical training and Electric Impedance Tomography (EIT) as biofeedback - POP-ART-Study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00023161

Enrollment

140

Registered

2021-02-03

Start date

2020-12-07

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

postsurgical pulmonary complications

Interventions

Group 1: Prospective examined intervention group with EIT as biofeedback for pre- and postsurgical breathing physiotherapy Group 2: Prospective examined intervention group without EIT as biofeedback f

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: No participation on other interventional studies at the same time. Ability to give consent. Present written declaration of consent from the study participant. Elective surgical operation of the upper abdomen using laparotomy under general anesthesia, e.g. gastrectomy, splenectomy, pancreatic surgery, partial liver resections (hemihepatectomies or open cholecystectomy.

Exclusion criteria

Exclusion criteria: For women: Existing pregnancy. Absence or impossibility of consent. Emergency patients. Patients with partial lung resections during surgery / thoracic surgery. Patients who underwent cardiac surgery = 3 months ago. BMI> 50. Pacemaker or implanted defibrillator. Other electrically active implants. Skin damage and bandages in the area of ??the EIT electrodes. Unstable spine. The last four exclusion criteria were based on the warnings from the manufacturer of the EIT device from Dräger AG Lübeck.

Design outcomes

Primary

Measure	Time frame
The pre- and postoperative instruction of breathing therapy exercises using EIT as biofeedback in patients with general upper abdominal surgery (arm 1) increases the oxygen saturation under room air on the second postoperative day from an average of 94% (+/- 3) to 98% (+/- 1) in comparison to otherwise identically treated patients only without EIT as biofeedback (arm 2) and can thus contribute to the reduction of PPC.	—

Measure

Time frame

The pre- and postoperative instruction of breathing therapy exercises using EIT as biofeedback in patients with general upper abdominal surgery (arm 1) increases the oxygen saturation under room air on the second postoperative day from an average of 94% (+/- 3) to 98% (+/- 1) in comparison to otherwise identically treated patients only without EIT as biofeedback (arm 2) and can thus contribute to the reduction of PPC.

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Secondary

Measure	Time frame
Comparison of arms 1 and 2 • EIT parameters (GI, COV, ID, IR, AUmax) • Outcome data (hospital mortality, ventilated/non-ventilated days, reintubation) Comparison of arms 1 and 2 each with arm 3 (historical comparison group with standard postoperative physiotherapy. • PPC rate • Outcome data (hospital mortality, ventilated/non-ventilated days, reintubation) Comparison of arms 1 and 2 each with arm 4 (test group with EIT-accompanied physiotherapy exercises) • Comparison with and without biofeedback by EIT preoperatively to arm 1 and 2 Analysis within the arm 3 • EIT parameters (GI, COV, ID, IR, AUmax) with and without biofeedback through EIT Post-hoc subgroup analysis as a selective analysis of PPC incidence • In patients who showed very homogeneous EIT values • In patients who have shown e.g. lower Vt with EIT Descriptive comparisons (for sample characterization) • SOFA (score for diagnosing sepsis), SAPS (score for assessing the physiological patient status), TISS (score for assessing the patient's condition from a nursing point of view) • Organ failure (delirium, cardiovascular system, kidney) • Surgical complications (yes/no) • Ventilator-free days in 30 days	—

Measure

Time frame

Comparison of arms 1 and 2 • EIT parameters (GI, COV, ID, IR, AUmax) • Outcome data (hospital mortality, ventilated/non-ventilated days, reintubation) Comparison of arms 1 and 2 each with arm 3 (historical comparison group with standard postoperative physiotherapy. • PPC rate • Outcome data (hospital mortality, ventilated/non-ventilated days, reintubation) Comparison of arms 1 and 2 each with arm 4 (test group with EIT-accompanied physiotherapy exercises) • Comparison with and without biofeedback by EIT preoperatively to arm 1 and 2 Analysis within the arm 3 • EIT parameters (GI, COV, ID, IR, AUmax) with and without biofeedback through EIT Post-hoc subgroup analysis as a selective analysis of PPC incidence • In patients who showed very homogeneous EIT values • In patients who have shown e.g. lower Vt with EIT Descriptive comparisons (for sample characterization) • SOFA (score for diagnosing sepsis), SAPS (score for assessing the physiological patient status), TISS (score for assessing the patient's condition from a nursing point of view) • Organ failure (delirium, cardiovascular system, kidney) • Surgical complications (yes/no) • Ventilator-free days in 30 days

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Countries

Germany

Contacts

Public ContactPauline Lohr

Universitätsmedizin der Johannes Gutenberg-Universität Mainz

pauline.lohr@unimedizin-mainz.de+496131177175

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026