Ultrasound Detection of Position of Diaphragm During Laparoscopic Surgery

Laparoscopy Clinical Trial

— UDLaS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03038061
• Other study ID #: NVT108-8/104-2015/ÚVN
• Status: Completed
• Phase: N/A
• Start date: December 1, 2015
• Est. completion date: February 24, 2021

Study information

• Verified date: February 2021
• Source: Czech Technical University in Prague
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: February 24, 2021
• Est. primary completion date: February 24, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• patients undergoing abdominal laparoscopic surgery

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Laparoscopy

Intervention

Other:
• 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).

Locations

Country	Name	City	State
Czechia	Military University Hospital	Prague

Sponsors (2)

Lead Sponsor	Collaborator
Czech Technical University in Prague	Military University Hospital, Prague

Country where clinical trial is conducted

Czechia, 

References & Publications (2)

Staehr-Rye AK, Rasmussen LS, Rosenberg J, Steen-Hansen C, Nielsen TF, Rosenstock CV, Clausen HV, Sørensen MK, VON H Regeur J, Gätke MR. Minimal impairment in pulmonary function following laparoscopic surgery. Acta Anaesthesiol Scand. 2014 Feb;58(2):198-205. doi: 10.1111/aas.12254. Epub 2014 Jan 2. — View Citation

Valenza F, Chevallard G, Fossali T, Salice V, Pizzocri M, Gattinoni L. Management of mechanical ventilation during laparoscopic surgery. Best Pract Res Clin Anaesthesiol. 2010 Jun;24(2):227-41. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Position of Diaphragm Detected by Ultrasound	Measurement in midclavicular line	Within one laparoscopic surgery (1-3 hours)