Ultrasound Detection of Position of Diaphragm During Laparoscopic Surgery

NCT ID: NCT03038061

Last Updated: 2021-02-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-01

Study Completion Date

2021-02-24

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Laparoscopy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Single group assignment. Approx. 20 patients during laparoscopic surgery with capnoperitoneum.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Experimental group

Patients undergoing Laparoscopic Surgery

Group Type EXPERIMENTAL

Patients undergoing Laparoscopic Surgery

Intervention Type 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).

Interventions

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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).

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

\- patients undergoing abdominal laparoscopic surgery

Exclusion Criteria

* morbid obesity
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Military University Hospital, Prague

OTHER

Sponsor Role collaborator

Czech Technical University in Prague

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Karel Roubik, Prof. Ph.D.

Role: STUDY_DIRECTOR

Czech Technical University in Prague

Martin Müller

Role: PRINCIPAL_INVESTIGATOR

Czech Technical University in Prague / Military University Hospital, Prague

Locations

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Military University Hospital

Prague, , Czechia

Site Status

Countries

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Czechia

References

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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.

Reference Type BACKGROUND
PMID: 24383568 (View on PubMed)

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.

Reference Type DERIVED
PMID: 29467544 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20608559 (View on PubMed)

Study Documents

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Document Type: Informed Consent Form

Informed Consent

View Document

Other Identifiers

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NVT108-8/104-2015/ÚVN

Identifier Type: -

Identifier Source: org_study_id

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