Hemodynamic Study With PRAM of the Cardiovascular Response to the Positioning of the Extraglottic Device

NCT02918526 | Unknown DMC

• 1 other identifier: AOUCareggi
• Study Type: interventional
• Target: 94
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of the study will be to record the hemodynamic response measured by traditional methods (non-invasive blood pressure and ECG) and Pressure Recording Analytical Method in patients undergoing laryngeal mask placement compared with the hemodynamic response measured in patients undergoing laryngoscopy and tracheal intubation for performing surgery in gynecological area and assess the differences with the two methods.

Conditions

Intubation Complication; Hemodynamic Instability

Keywords

Laryngeal masks

Outcome Measures

Primary Outcomes (1)

• Cardiac Index (L/min/m2)

  Cardiac Index (L/min/m2) measured with Pulse Recording Analytic Method

  for 5 minutes after induction of anesthesia

Secondary Outcomes (8)

• Heart rate (bpm)

  for 5 minutes after induction of anesthesia

• Blood pressure (mmHg)

  for 5 minutes after induction of anesthesia

• Cardiac Output (CO) (L/min)

  for 5 minutes after induction of anesthesia

• Stroke Volume (SV) (ml/beat)

  for 5 minutes after induction of anesthesia

• Stroke Volume Index (SVI) (ml/beat /m2)

  for 5 minutes after induction of anesthesia

Study Arms (2)

Laryngeal Mask

EXPERIMENTAL

laryngeal mask (LMA)

Device: airway management

Oro Tracheal Intubation

ACTIVE COMPARATOR

oro tracheal intubation

Device: airway management

Interventions

airway management DEVICE

airway management with Laryngeal Mask or Oro Tracheal Intubation

Laryngeal Mask; Oro Tracheal Intubation

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients scheduled for elective gynecological surgery under general anesthesia
• Age \>18 \<50 years
• Presence of informed consent in the clinical record
• Belonging to risk classes ASA 1 - ASA 2

You may not qualify if:

• Hypertension
• Heart failure
• Treatment with beta blockers, Ca channel blockers, antihypertensives, vagolytic
• Hypo/hyperthyroidism and its treatment
• Adrenal insufficiency and its treatment
• Autonomic neuropathy

Sponsors & Collaborators

• Azienda Ospedaliero-Universitaria Careggi: lead

Related Publications (11)

• Efe EM, Bilgin BA, Alanoglu Z, Akbaba M, Denker C. Comparison of bolus and continuous infusion of esmolol on hemodynamic response to laryngoscopy, endotracheal intubation and sternotomy in coronary artery bypass graft. Braz J Anesthesiol. 2014 Jul-Aug;64(4):247-52. doi: 10.1016/j.bjane.2013.07.003. Epub 2013 Oct 25.

  PMID: 24998108 BACKGROUND

• Lee SY, Min JJ, Kim HJ, Hong DM, Kim HJ, Park HP. Hemodynamic effects of topical lidocaine on the laryngoscope blade and trachea during endotracheal intubation: a prospective, double-blind, randomized study. J Anesth. 2014 Oct;28(5):668-75. doi: 10.1007/s00540-014-1812-z. Epub 2014 Mar 12.

  PMID: 24619576 BACKGROUND

• Daabiss M, Hashish M. Effects of lornoxicam on the hemodynamic and catecholamine response to laryngoscopy and tracheal intubation. Eur J Clin Pharmacol. 2011 Aug;67(8):783-6. doi: 10.1007/s00228-011-1017-4. Epub 2011 Mar 3.

  PMID: 21369950 BACKGROUND

• Min JH, Chai HS, Kim YH, Chae YK, Choi SS, Lee A, Choi YS. Attenuation of hemodynamic responses to laryngoscopy and tracheal intubation during rapid sequence induction: remifentanil vs. lidocaine with esmolol. Minerva Anestesiol. 2010 Mar;76(3):188-92.

  PMID: 20203546 BACKGROUND

• Sun HL, Wu TJ, Ng CC, Chien CC, Huang CC, Chie WC. Efficacy of oropharyngeal lidocaine instillation on hemodynamic responses to orotracheal intubation. J Clin Anesth. 2009 Mar;21(2):103-7. doi: 10.1016/j.jclinane.2008.06.028.

  PMID: 19329013 BACKGROUND

• Perello-Cerda L, Fabregas N, Lopez AM, Rios J, Tercero J, Carrero E, Hurtado P, Hervias A, Gracia I, Caral L, de Riva N, Valero R. ProSeal Laryngeal Mask Airway Attenuates Systemic and Cerebral Hemodynamic Response During Awakening of Neurosurgical Patients: A Randomized Clinical Trial. J Neurosurg Anesthesiol. 2015 Jul;27(3):194-202. doi: 10.1097/ANA.0000000000000108.

  PMID: 25121397 BACKGROUND

• Agrawal G, Agarwal M, Taneja S. A randomized comparative study of intraocular pressure and hemodynamic changes on insertion of proseal laryngeal mask airway and conventional tracheal intubation in pediatric patients. J Anaesthesiol Clin Pharmacol. 2012 Jul;28(3):326-9. doi: 10.4103/0970-9185.98325.

  PMID: 22869938 BACKGROUND

• Romano SM, Pistolesi M. Assessment of cardiac output from systemic arterial pressure in humans. Crit Care Med. 2002 Aug;30(8):1834-41. doi: 10.1097/00003246-200208000-00027.

  PMID: 12163802 BACKGROUND

• Scolletta S, Romano SM, Biagioli B, Capannini G, Giomarelli P. Pressure recording analytical method (PRAM) for measurement of cardiac output during various haemodynamic states. Br J Anaesth. 2005 Aug;95(2):159-65. doi: 10.1093/bja/aei154. Epub 2005 May 13.

  PMID: 15894561 BACKGROUND

• Petrini F, Accorsi A, Adrario E, Agro F, Amicucci G, Antonelli M, Azzeri F, Baroncini S, Bettelli G, Cafaggi C, Cattano D, Chinelli E, Corbanese U, Corso R, Della Puppa A, Di Filippo A, Facco E, Favaro R, Favero R, Frova G, Giunta F, Giurati G, Giusti F, Guarino A, Iannuzzi E, Ivani G, Mazzon D, Menarini M, Merli G, Mondello E, Muttini S, Nardi G, Pigna A, Pittoni G, Ripamonti D, Rosa G, Rosi R, Salvo I, Sarti A, Serafini G, Servadio G, Sgandurra A, Sorbello M, Tana F, Tufano R, Vesconi S, Villani A, Zauli M; Gruppo di Studio SIAARTI "Vie Aeree Difficili"; IRC e SARNePI; Task Force. Recommendations for airway control and difficult airway management. Minerva Anestesiol. 2005 Nov;71(11):617-57. No abstract available. English, Italian.

  PMID: 16278626 BACKGROUND

• Abdelgawad AF, Shi QF, Halawa MA, Wu ZL, Wu ZY, Chen XD, Yao SL. Comparison of cardiac output and hemodynamic responses of intubation among different videolaryngoscopies in normotensive and hypertensive patients. J Huazhong Univ Sci Technolog Med Sci. 2015 Jun;35(3):432-438. doi: 10.1007/s11596-015-1449-7. Epub 2015 Jun 14.

  PMID: 26072085 BACKGROUND

MeSH Terms

Interventions

Airway Management

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Alessandro Di Filippo, MD

  Azienda Ospedaliero-Universitaria Careggi

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alessandro Di Filippo, MD

CONTACT

3397219337; adifilippo@unifi.it

Massimo Micaglio, MD

CONTACT

3357766532; m.micaglio@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: September 24, 2016
• First Posted: September 29, 2016
• Study Start: October 1, 2016
• Primary Completion: March 1, 2017
• Study Completion: June 1, 2017
• Last Updated: September 29, 2016

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will share