Early Detection of Intra Operative Hypotension (IOH) During the Induction of General Anaesthesia

NCT03756935 | Completed

• 1 other identifier: JMATEO
• Study Type: observational
• Target: 62
• Locations: 0 countries
• Sites: N/A

Brief Summary

During general anaesthesia, intraoperative hypotension (IOH), defined as a mean arterial pressure (MAP) drop of more than 20%, is frequent with potential deleterious effects for patients. Pulse oximeter is mandatory in the operating room making photoplethysmographic (PPG) signal and parameters such as the relative dicrotic notch height (Dicpleth) or the perfusion index (PI) readily available. The purpose of this study is to investigate whether Dicpleth and PI could detect IOH during anaesthesia induction and follow their variations during vasopressor boluses.

Conditions

Radiography; Interventional

Outcome Measures

Primary Outcomes (2)

• Continuous measure of mean arterial pressure (MAP in mmHg)

  We calculated the variation of MAP during the induction period from the relative variations (in percent) from their baseline values. During vasopressor boluses, respective parameter's variations are calculated between "pre-pressor" and "peak-pressor" measurements.

  Time Frame: duration of the interventional neuroradiology procedure: 1 day

• Continuous measure of SpO2 in % by photoplethysmography

  We calculated variations of Dicpleth, and perfusion index (PI) during the induction period from the relative variations (in percent) from their baseline values. During vasopressor boluses, respective parameter's variations are calculated between "pre-pressor" and "peak-pressor" measurements.

  Time Frame: duration of the interventional neuroradiology procedure: 1 day

Interventions

All monitoring PROCEDURE

Dicpleth and PI are obtained a posteriori from the PPG waveform reconstruction and blindly from ABP values. Dicpleth is defined as the ratio of the height of the dicrotic notch (from nadir point of the complex to the notch) to the height of the systolic peak (from nadir point of the complex to the pic), measured at end-expiratory time (average of 3 consecutive complex). PI is calculated as the ratio of the pulsatile component of the PPG signal and the continuous component.

Eligibility Criteria

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

Study Population

patients with scheduled an elective interventional neuroradiology procedure requiring general anesthesia

You may qualify if:

• patients \> 18 years, scheduled an elective interventional neuroradiology procedure requiring general anesthesia
• oral agreement obtained from each patient before anesthesia

You may not qualify if:

• age \<18 years
• an emergency procedure

Sponsors & Collaborators

• Hopital Lariboisière: lead
• INSERM UMR-942, Paris, France: collaborator
• M3DISIM: collaborator

Related Publications (1)

• Coutrot M, Joachim J, Depret F, Millasseau S, Nougue H, Mateo J, Mebazaa A, Gayat E, Vallee F. Noninvasive continuous detection of arterial hypotension during induction of anaesthesia using a photoplethysmographic signal: proof of concept. Br J Anaesth. 2019 May;122(5):605-612. doi: 10.1016/j.bja.2019.01.037. Epub 2019 Mar 11.

  PMID: 30916032 DERIVED

Study Officials

• Joaquim MATEO, MD

  Hopital Lariboisière

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: November 16, 2018
• First Posted: November 28, 2018
• Study Start: November 1, 2014
• Primary Completion: May 23, 2015
• Study Completion: May 23, 2015
• Last Updated: November 28, 2018

Record last verified: 2018-11