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Completed

NCT Number: NCT03038061

Ultrasound Detection of Position of Diaphragm During Laparoscopic Surgery

Position of diaphragm in the region of electrical impedance tomography measurement is to be determined by ultrasound in approx. 20 patients undergoing laparoscopic surgery. Data are to be obtained at three phases at supine horizontal position (during spontaneous breathing, at mechanically ventilated patient under general anesthesia with muscle relaxation and at mechanically ventilated patient under general anesthesia with muscle relaxation during insufflation of carbon dioxide into the peritoneal cavity to achieve exposure during laparoscopic surgery).

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Key information

Conditions

Laparoscopy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Military University Hospital

Prague, 16902, Czechia

About this study

During laparoscopic surgery, insufflation of carbon dioxide into the peritoneal cavity is conducted in order to optimize working space for surgeons. As a side effect, the abdominal pressure alters physiological thoraco-abdominal configuration and pushes the diaphragm and lungs cranially. Since lung image acquired by electrical impedance tomography (EIT) depends on the conditions within the thorax and abdomen, it is crucial to know the diaphragm position to analyze the effect of cranial shift of diaphragm on EIT images of the thorax. Presence of diaphragm in the region of EIT measurement is to be determined by ultrasound in approx. 20 patients undergoing laparoscopic surgery. Data are to be obtained at three phases at supine horizontal position (during spontaneous breathing, at mechanically ventilated patient under general anesthesia with muscle relaxation and at mechanically ventilated patient under general anesthesia with muscle relaxation during insufflation of carbon dioxide into the peritoneal cavity to achieve exposure during laparoscopic surgery). The results of this study will serve during design of a subsequent study dealing with optimization of EIT electrode belt position during laparoscopic surgery.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients undergoing abdominal laparoscopic surgery

Exclusion criteria

  • morbid obesity
  • standard exclusion criteria for electrical impedance tomography according to the manufacturer

Treatment and study plan

Patients undergoing Laparoscopic Surgery

Other

Data are to be obtained at three phases at supine horizontal position (during spontaneous breathing, at mechanically ventilated patient under general anesthesia with muscle relaxation and at mechanically ventilated patient under general anesthesia with muscle relaxation during insufflation of carbon dioxide into the peritoneal cavity to achieve exposure during laparoscopic surgery).

Primary outcomes

  1. Position of Diaphragm Detected by Ultrasound

    Time frame: Within one laparoscopic surgery (1-3 hours)

    Measurement in midclavicular line

Sponsors and collaborators

Lead sponsor

Czech Technical University in Prague

Other

Collaborators

  • Military University Hospital, Prague

Registry information

Official study title

Ultrasound Detection of Presence of Diaphragm in the Region of Lung Monitoring Using Electrical Impedance Tomography During Laparoscopic Surgery

Acronym: UDLaS

Important dates

Study start
2015
Primary completion
2021
Study completion
2021
First posted
Jan 31, 2017
Registry last updated
Feb 25, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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