Open-label, multicenter, prospective, randomized trial of breath-synchronized electrical abdominal stimulation in patients with acute tetraplegia

Open-label, multicenter, prospective, randomized trial of breath-synchronized electrical abdominal stimulation in patients with acute tetraplegia - Multi AbdomenStim

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00005146

Enrollment

228

Registered

2013-09-03

Start date

2013-07-01

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

G80.0 J18.0

Interventions

Group 1: The patients received standard respiratory therapy with physiotherapy, inhalation and suction. In addition, a stimulation of the abdominal muscles twice a day depending on exhalation breath.

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Inclusion criteria

Inclusion criteria: Men and women; neurological level C4-C8; ASIA (Amercian Spinal Injury Assication) Typ A, B; Paralysis not older than 6 weeks; Body Mass Index <35; Age 18-80 years; Consent by the patient

Exclusion criteria

Exclusion criteria: Lack of consent; Acute pneumonia (CDC definition); Known pulmonary disease (COPD> VI °); Heart failure class III; Progressive disease, tumor; Lack of opportunity to place abdominal electrodes; pregnancy; Pacemaker or similar implants which interfere with electrical stimulation

Design outcomes

Primary

Measure	Time frame
Number of acute pneumonia by CDC definition during the treatment period. There is a daily clinical examination of the patient by the study doctor to signs of infection and signs of pulmonary complication. If it is suspected further investigations (X-ray, sputum, antibiogram according to CDC criteria) are introduced Pneumonia must be confirmed by the clinical investigator who is not informed about the therapy process (blinding) (four-eyes principle).	—

Measure

Time frame

Number of acute pneumonia by CDC definition during the treatment period. There is a daily clinical examination of the patient by the study doctor to signs of infection and signs of pulmonary complication. If it is suspected further investigations (X-ray, sputum, antibiogram according to CDC criteria) are introduced Pneumonia must be confirmed by the clinical investigator who is not informed about the therapy process (blinding) (four-eyes principle).

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Secondary

Measure	Time frame
To check the influence of stimulation of the abdominal muscles on the circulatory regulation, a modified Schellong test is performed. The investigation is carried out every second day in the morning before the start of therapy. At the beginning the blood pressure is measured every minute over a period of 5 minutes. Following the rearrangement takes place in the highest possible upright seating position and re-measuring the blood pressure every minute for five minutes. This is followed by the abdominal stimulation.	—

Measure

Time frame

To check the influence of stimulation of the abdominal muscles on the circulatory regulation, a modified Schellong test is performed. The investigation is carried out every second day in the morning before the start of therapy. At the beginning the blood pressure is measured every minute over a period of 5 minutes. Following the rearrangement takes place in the highest possible upright seating position and re-measuring the blood pressure every minute for five minutes. This is followed by the abdominal stimulation.

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Countries

Germany

Contacts

Public ContactAndreas Niedeggen

Unfallkrankenhaus Berlin

Andreas.Niedeggen@ukb.de030 5681 3401

Outcome results

None listed

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