AzTrials
AzTrials

Percutaneous Endoscopic Gastrostomy (PEG)TIMPEGNCT04202029

Additional Benefit of Thoracic Impedance Monitoring (TIM) for Propofol-sedation Monitoring During PEG Placement

A study testing thoracic impedance monitoring, pulseoxymetry and non-invasive blood preassure monitoring in people with Percutaneous Endoscopic Gastrostomy (PEG), run by Georg Dultz at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The present study is a randomized, prospective, single-blinded study. A total of 172 patients presenting for percoutaneous endoscopic gastrostomy (PEG) under sedation will be included according to the statistical sample size calculation. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
thoracic impedance monitoring, pulseoxymetry and non-invasive blood preassure monitoring
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
173 participants
Where
1 siteGermany
Study dates
4 Nov 2019to 24 Aug 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • > /= 18 years
  • given consent
  • planned PEG

Who cannot join

  • ASA >/= 4
  • no given consent
  • pregnant/laction
  • contraindication against PEG
  • contraindication against propofol-sedatation

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Klinikum der J. W. Goethe-Universität

    Frankfurt am Main, 60590

Other trials in Germany

About this study

Official title: Additional Benefit of Thoracic Impedance Monitoring (TIM) for Propofol-sedation Monitoring by Non- Anesthesiologist During Percutaneous Endoscopic Gastrostomy (PEG), a Prospective, Randomized-controlled Clinical Study.

The present study is a randomized, prospective, single-blinded study. A total of 172 patients presenting for percoutaneous endoscopic gastrostomy (PEG) under sedation will be included according to the statistical sample size calculation. Patients will be randomized to either group 1- standard monitoring (pulseoxymetry and non-invasive blood preassure monitoring) or group 2- standard monitoring and thoracic impedance measurement during Propofol-based sedation for PEG. Episodes of Hypoxia are documented and compared in both groups.

Statistical analysis will be done in cooperation with the statistical biomedical institute oft he university hospital in Frankfurt.

Being tested
thoracic impedance monitoring, pulseoxymetry, non-invasive blood preassure monitoring
Keywords
ASA, American Socity of Anesthesiologists physical status classification system, Thoracic Impedance monitoring, TIM, ECG, echocardiography, sedation, propofol, monitoring, NAPS, nurse-administered propofol sedation, O2, oxygen, PEG, percutaneous endoscopic gastrostomy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • thoracic impedance monitoringDevice

    Thoracic impedance measurement identifies the respiratory frequence using the changes of impedance during inspiration and expiration via an ECG.

  • pulseoxymetryDevice

    Pulseoxymetry is meassuring the heart rate and the oxygen saturation in the arterial blood

  • non-invasive blood preassure monitoringDevice

    Non-invasive blood preassure is a method using a blood preassure cuff to identify the blood preassure.

Study groups in NCT04202029
Study groupRoleWhat they receive
pulseoxymetry armOtherpulseoxymetry arm: standard monitoring: pulseoxymetry and non-invasive blood preassure monitoring
Receives: Device: pulseoxymetry; Device: non-invasive blood preassure monitoring
thoracic impedance monitoring armExperimentalthoracic impedance monitoring arm: standard monitoring and additionally thoracic impedance measurement)
Receives: Device: thoracic impedance monitoring; Device: pulseoxymetry; Device: non-invasive blood preassure monitoring

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. comparison of hypoxia in both arms

    Hypoxia is defined as oxygen saturation dropping below 90 % for more than 15 seconds. The primary end point is assessed from the beginning of propofol sedation until the PEG-procedure is terminated defined by awaking of the patient.

    Measured: Average duration period of PEG-placement: approx. 15 minutes.

Secondary outcomes (11)

  1. Comparison of hypoxia-episodes in both arms

    Number of hypoxia-episodes during each intervention. This end point is assessed from the beginning of propofol sedation until the PEG-procedure is terminated defined by awaking of the patient.

    Measured: Average duration period of PEG-placement: approx. 15 minutes.

  2. Comparison of severe hypoxia episodes in both arms defined as oxygen saturation dropping below 85 %

    Severe hypoxia is defined as O2 saturation below 85%. This end point is assessed from the beginning of propofol sedatio n until the PEG-procedure is terminated defined by awaking of the patient.

    Measured: Average duration period of PEG-placement: approx. 15 minutes.

  3. Comparison of severe hypoxia-episodes in both arms

    The number of hypoxia-episodes during each intervention will be assesed. This end point is assessed from the beginning of propofol sedation until the PEG-procedure is terminated defined by awaking of the patient.

    Measured: Average duration period of PEG-placement: approx. 15 minutes. This end point is assessed from the beginning of propofol sedation until the PEG-procedure is terminated defined by awaking of the patient.

  4. Comparison of the time difference of occuring apnoe before hypoxia

    The time difference between the onset of apnoe befpre the onset of hypoxia will be meassured.

    Measured: Average duration period of PEG-placement: approx. 15 minutes.

  5. Specifity and sensetivity of thoracic impedance monitoring

    The specifity and sensitivity will be calculated using the frequency of falls alarms and missed alarms in relation to hypoxia. This end point is assessed from the beginning of propofol sedation until the PEG-procedure is terminated defined by awaking of the patient.

    Measured: Average duration period of PEG-placement: approx. 15 minutes.

  6. Additional cost of thoracic impedance monitoring (TIM)

    The costs that are needed to implement TIM during every procedure will be calculated and will be stated in the results. All PEG-placements in the TIM group will be used. By using a 3-lead-ECG, 3 electrodes will be needed per patient. For alle patients, one ECG-cable will be needed. Therefore, the costs will be calculated per patient.

    Measured: Time frame is the entire study period with a maximum of 3 years.

  7. Risk stratification of baseline criteria for hypoxia

    Risk factors will be evaluated in an univariate and a multivariate analyse

    Measured: Time frame is the entire study period with a maximum of 3 years.

  8. Comparison of intervention procedures to prevent hypoxia

    The necessity to prevent a hypoxic event because of an alarm by the monitoring by elevating the oxygen delivery, using jaw thrust manoeuvre or mask ventilation will be compared in both arms. This end point is assessed from the beginning of propofol sedation until the PEG-procedure is terminated defined by the awaking of the patient.

    Measured: Average duration period of PEG-placement: approx. 15 minutes.

  9. Comparison of satisfaction of doctors in both arms

    The involved doctors will be asked to give there opinion using visual analog scale (VAS). Scale reaches from 1 (dissatisfied) to 10 (satisfied). The end point will be meassured after the procedure. The investigation time is defined as one PEG-placement.

    Measured: approx. 15 minutes

  10. Comparison of satisfaction of nurses in both arms

    The involved nurses will be asked to give there opinion using visual analog scale (VAS). Scale reaches from 1 (dissatisfied) to 10 (satisfied). The end point will be meassured after the procedure. The investigation time is defined as one PEG-placement.

    Measured: approx. 15 minutes

  11. Comparison of satisfaction of patients in both arms

    The involved patients will be asked to give there opinion using visual analog scale (VAS). Scale reaches from 1 (dissatisfied) to 10 (satisfied). The end point will be meassured after the procedure. The investigation time is defined as one PEG-placement.

    Measured: approx. 15 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Dec 2019
  2. Study start4 Nov 2019
  3. Primary completion24 Aug 2021
  4. Study completion24 Aug 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
The participants will be randomely assigend by a computer based algorithm to either the standard monitoring group as defined by the German S3 guidline "Sedierung in der gastrointestinalen Endoskopie" containing pulsoxymetry and non-invasive blood preassure monitoring versus the standard and additionally the thoracic impedance monitoring using an extra ECG
Masking
Single blind
Who is masked
Participant
Enrolment
173 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04202029
Sponsor's protocol ID
FRA-UNI-TIM-PEG-TRIAL-2019
Acronym
TIMPEG
Status last verified
May 2020
First submitted
3 Nov 2019
Last updated
13 Jul 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Jafari A, Weismuller TJ, Tonguc T, Kalff JC, Manekeller S. [Complications after Percutaneous Endoscopic Gastrostomy Tube Placement - A Retrospective Analysis]. Zentralbl Chir. 2016 Aug;141(4):442-5. doi: 10.1055/s-0035-1557765. Epub 2015 Aug 10. German.

    PubMed 26258619

  • Riphaus A, Rabofski M, Wehrmann T. Endoscopic sedation and monitoring practice in Germany: results from the first nationwide survey. Z Gastroenterol. 2010 Mar;48(3):392-7. doi: 10.1055/s-0028-1109765. Epub 2010 Feb 5.

    PubMed 20140841

  • Riphaus A, Geist F, Wehrmann T. Endoscopic sedation and monitoring practice in Germany: re-evaluation from the first nationwide survey 3 years after the implementation of an evidence and consent based national guideline. Z Gastroenterol. 2013 Sep;51(9):1082-8. doi: 10.1055/s-0033-1335104. Epub 2013 Sep 10.

    PubMed 24022202

  • Lin OS. Sedation for routine gastrointestinal endoscopic procedures: a review on efficacy, safety, efficiency, cost and satisfaction. Intest Res. 2017 Oct;15(4):456-466. doi: 10.5217/ir.2017.15.4.456. Epub 2017 Oct 23.

    PubMed 29142513

  • Dumonceau JM, Riphaus A, Aparicio JR, Beilenhoff U, Knape JT, Ortmann M, Paspatis G, Ponsioen CY, Racz I, Schreiber F, Vilmann P, Wehrmann T, Wientjes C, Walder B; NAAP Task Force Members. European Society of Gastrointestinal Endoscopy, European Society of Gastroenterology and Endoscopy Nurses and Associates, and the European Society of Anaesthesiology Guideline: Non-anaesthesiologist administration of propofol for GI endoscopy. Eur J Anaesthesiol. 2010 Dec;27(12):1016-30. doi: 10.1097/EJA.0b013e32834136bf.

    PubMed 21068575

  • Riphaus A, Wehrmann T, Hausmann J, Weber B, von Delius S, Jung M, Tonner P, Arnold J, Behrens A, Beilenhoff U, Bitter H, Domagk D, In der Smitten S, Kallinowski B, Meining A, Schaible A, Schilling D, Seifert H, Wappler F, Kopp I; German Society of General and Visceral Surgery; German Crohn's disease / ulcerative colitis Association e. V; German Society of Anaesthesiology and Intensive Care Medicine e. V. (DGAI); Gesellschaft Politics and Law in Health Care (GPRG). [S3-guidelines "sedation in gastrointestinal endoscopy" 2014 (AWMF register no. 021/014)]. Z Gastroenterol. 2015 Aug;53(8):802-42. doi: 10.1055/s-0035-1553458. Epub 2015 Aug 18. No abstract available. German.

    PubMed 26284330

  • Absolom M, Roberts R, Bahlmann UB, Hall JE, Armstrong T, Turley A. The use of impedance respirometry to confirm tracheal intubation in children. Anaesthesia. 2006 Dec;61(12):1145-8. doi: 10.1111/j.1365-2044.2006.04838.x.

    PubMed 17090233

  • Frasca D, Geraud L, Charriere JM, Debaene B, Mimoz O. Comparison of acoustic and impedance methods with mask capnometry to assess respiration rate in obese patients recovering from general anaesthesia. Anaesthesia. 2015 Jan;70(1):26-31. doi: 10.1111/anae.12799. Epub 2014 Jul 10.

    PubMed 25040754

Questions about this trial

What is this clinical trial studying?

A study testing thoracic impedance monitoring, pulseoxymetry and non-invasive blood preassure monitoring in people with Percutaneous Endoscopic Gastrostomy (PEG), run by Georg Dultz at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

comparison of hypoxia in both arms (time frame: Average duration period of PEG-placement: approx. 15 minutes.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04202029, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in