Ultrasound Detection of Position of Diaphragm During Laparoscopic Surgery

NCT03038061 | Completed

• 1 other identifier: NVT108-8/104-2015/ÚVN
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Laparoscopy

Keywords

Diaphragm; EIT; Laparoscopy

Outcome Measures

Primary Outcomes (1)

• Position of Diaphragm Detected by Ultrasound

  Measurement in midclavicular line

  Within one laparoscopic surgery (1-3 hours)

Study Arms (1)

Experimental group

EXPERIMENTAL

Patients undergoing Laparoscopic Surgery

Other: Patients undergoing Laparoscopic Surgery

Interventions

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).

Experimental group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- patients undergoing abdominal laparoscopic surgery

You may not qualify if:

• morbid obesity

Sponsors & Collaborators

• Czech Technical University in Prague: lead
• Military University Hospital, Prague: collaborator

Study Sites (1)

Military University Hospital

Prague, 16902, Czechia

Location

Related Publications (3)

• 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. doi: 10.1016/j.bpa.2010.02.002.

  PMID: 20608559 BACKGROUND

• Staehr-Rye AK, Rasmussen LS, Rosenberg J, Steen-Hansen C, Nielsen TF, Rosenstock CV, Clausen HV, Sorensen MK, VON H Regeur J, Gatke 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.

  PMID: 24383568 BACKGROUND

• Buzkova K, Muller M, Rara A, Roubik K, Tyll T. Ultrasound detection of diaphragm position in the region for lung monitoring by electrical impedance tomography during laparoscopy. Biomed Pap Med Fac Univ Palacky Olomouc Czech Repub. 2018 Mar;162(1):43-46. doi: 10.5507/bp.2018.005. Epub 2018 Feb 21.

  PMID: 29467544 DERIVED

Study Officials

• Karel Roubik, Prof. Ph.D.

  Czech Technical University in Prague

  STUDY DIRECTOR

• Martin Müller

  Czech Technical University in Prague / Military University Hospital, Prague

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single group assignment. Approx. 20 patients during laparoscopic surgery with capnoperitoneum.

Study Record Dates

• First Submitted: January 28, 2017
• First Posted: January 31, 2017
• Study Start: December 1, 2015
• Primary Completion: February 24, 2021
• Study Completion: February 24, 2021
• Last Updated: February 25, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)