Pressure Support Ventilation Versus Continuous Positive Air Way Pressure (CPAP) Using I Gelin Adult Patients,

NCT05116839 | Unknown DMC

• 1 other identifier: MS/19.03.556
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

Introduction of Supra glottic airway devices (SAD) has revolutionized the airway management. The first successful supraglottic airway device, the Laryngeal Mask Airway(LMA).The various other SADs include ProSeal LMA, Intubating LMA and i-gel to overcome the limitations of classic Laryngeal Mask Airway( c-LMA) The risk of aspiration with c-LMA is reported tobe around 9% , pleaseboth the c-LMA and PLMA have cuff related complications. High cuff pressure in laryngeal mask airways can cause damage to the mucosae on periglottic and supraglottic structures . Therefore, to overcome the limitations of Pro Seal Laryngeal Mask Airway (PLMA )a new and cheaper SAD called i-gel was developed. i-gel is a novel and innovative, latex free supraglottic device, made up of medical grade thermoplastic elastomer, which is soft, gel like, transparent The number of manipulations required are more in PLMA than i gel resulting in hemodynamic changes .The i-gel is comparable to PLMA insuring the airway during controlled ventilation. It is better than PLMA in terms of ease of insertion. Spontaneous breathing is the most popular mode of ventilation with the laryngeal mask airway (LMA), but it provides less effective gas exchange than does positive pressure ventilation (PPV) . The patients receiving sevoflurane anesthesia with unassisted ventilation have a reduced rib cage contribution to ventilation, decreased tidal volume, and respiratory rate . Pressure support ventilation (PSV) is a ventilator mode that is initiated by the patient and synchronized with the patient's respiratory effort. And may improve gaseous exchange in patients. In the intensive care unit, it is often considered the preferred mode for weaning mechanical ventilation .PSV provides more effective gas exchange than does unassisted ventilation with CPAP during anesthesia with the LMA while preserving hemodynamic homeostasis. The use of PSV versus CPAP with the Pro Seal laryngeal mask airway in anesthetized pediatric patients revealed that PSV improved gaseous exchange and reduced work of breathing during general anesthesia PSV via Pro- Seal laryngeal mask airway improves gaseous exchange and ventilation in pediatric patients under general anesthesia more than spontaneous ventilation .

Conditions

Ventilator Lung

Keywords

Pressure support ventilation (CPAP) I gel

Outcome Measures

Primary Outcomes (6)

• Effective ventilation with PSV than does (CPAP) as regard Tidal volume

  Breathing of all patients at the first 15 minutes with PSV pressure support ventilation:triggered by minute volume \<3 liter,with no frequency then the following 15 minutes ventilation with CPAP .ventilation will be measured by Monitoring: (basal\& every 3minutes)Tidal volume (inspiratory \& expiratory).on ventilator monitor in mil/ kilogram

  30 minutes

• Effective ventilation with PSV than does (CPAP) as regard End tidal co2. on ventilator

  Breathing of all patients at the first 15 minutes with PSV pressure support ventilation:triggered by minute volume \<3 liter,with no frequency then the following 15 minutes ventilation with CPAP.ventilation will be measured by Monitoring: (basal\& every 3minutes) End tidal co2. on ventilator ml/eq

  30 minutes

• Effective ventilation with PSV than does CPAP as regard Mean air way pressure

  Breathing of all patients at the first 15 minutes with PSV pressure support ventilation:triggered by minute volume \<3 liter,with no frequency then the following 15 minutes ventilation with CPAP.ventilation will be measured by Monitoring: (basal\& every 3minutes) Mean air way pressure.on ventilator mmhg

  30 minutes

• Effective ventilation with PSV than does (CPAP) as regard Leakage %

  Breathing of all patients at the first 15 minutes with PSVpressure support ventilation:triggered by minute volume \<3 liter,with no frequency then the following 15 minutes ventilation with CPAP.ventilation will be measured by Monitoring: (basal\& every 3minutes) Leakage % on ventilator monitor

  30 minutes

• Effective ventilation with PSV than does CPAP as regard oxygen saturation.

  Breathing of all patients at the first 15 minutes with PSV pressure support ventilation:triggered by minute volume \<3 liter,with no frequency then the following 15 minutes ventilation with CPAP.ventilation will be measured by Monitoring: (basal\& every 3minutes) oxygen saturation.on monitoring in %

  30 minutes

• Effective ventilation with PSV than does (CPAP) as regard respiratory rate

  Breathing of all patients at the first 15 minutes with PSV pressure support ventilation:triggered by minute volume \<3 liter,with no frequency then the following 15 minutes ventilation with CPAP .ventilation will be measured by Monitoring: (basal\& every 3minute)respiratory rate on monitor breath/ minute

  30 minutes

Study Arms (2)

the first 15 minutes with PSV

PLACEBO COMPARATOR

All patients will breath at the first 15 minutes with PSV:triggered by minute volume \<3 Liter,with with no frequency . Monitoring: (basal\&every 3minutes) 1. Tidal volume (inspiratory \& expiratory). 2. End tidal co2. 3. Mean air way pressure. 4. Leakage %. 5. Respiratory rate . 6. Spo2. 7. Heart rate. 8. Blood pressure (mean arterial pressure

Device: the first 15 minutes with pressure support ventilation; Device: i gel air way

the following 15 minutes ventilation will be changed to CPAP mode

ACTIVE COMPARATOR

then the following 15 minutes ventilation will be changed to CPAP mode at 10 cm H2o . Monitoring: (basal\&every 3minutes) 1. Tidal volume (inspiratory \& expiratory). 2. End tidal co2. 3. Mean air way pressure. 4. Leakage %. 5. Respiratory rate . 6. Spo2. 7. Heart rate. 8. Blood pressure (mean arterial pressure).

Device: the following 15 minutes ventilation will be changed to continous positive air way pressureCPAP mode; Device: i gel air way

Interventions

the first 15 minutes with pressure support ventilation DEVICE

PSV pressure support ventilation:triggered by minute volume \< 3 Liter ,with no frequency

Also known as: lung mechanical ventilatory mode on mechanical ventilator

the first 15 minutes with PSV

the following 15 minutes ventilation will be changed to continous positive air way pressureCPAP mode DEVICE

continous positive air way pressure CPAP mode at 10 cm H2o .

Also known as: lung mechanical ventilatory mode on mechanical ventilator

the following 15 minutes ventilation will be changed to CPAP mode

i gel air way DEVICE

supraglottic air way device

the first 15 minutes with PSV; the following 15 minutes ventilation will be changed to CPAP mode

Eligibility Criteria

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

You may qualify if:

• Adult patients with (ASA) physical status I - II years scheduled for minor surgery at Urology and Nephrology centre (UNC) will be included in this study.

You may not qualify if:

• The Patients with a body mass index (BMI) \>40 or having obstructive air way disease will be excluded.•

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Marwa Ibrahim Mohamed abdo

Al Mansurah, Egypt

RECRUITING

Related Publications (11)

• Barker P, Langton JA, Murphy PJ, Rowbotham DJ. Regurgitation of gastric contents during general anaesthesia using the laryngeal mask airway. Br J Anaesth. 1992 Sep;69(3):314-5. doi: 10.1093/bja/69.3.314.

  PMID: 1389850 BACKGROUND

• Wong JG, Heaney M, Chambers NA, Erb TO, von Ungern-Sternberg BS. Impact of laryngeal mask airway cuff pressures on the incidence of sore throat in children. Paediatr Anaesth. 2009 May;19(5):464-9. doi: 10.1111/j.1460-9592.2009.02968.x. Epub 2009 Mar 5.

  PMID: 19281479 BACKGROUND

• Levitan RM, Kinkle WC. Initial anatomic investigations of the I-gel airway: a novel supraglottic airway without inflatable cuff. Anaesthesia. 2005 Oct;60(10):1022-6. doi: 10.1111/j.1365-2044.2005.04258.x.

  PMID: 16179048 BACKGROUND

• Chauhan G, Nayar P, Seth A, Gupta K, Panwar M, Agrawal N. Comparison of clinical performance of the I-gel with LMA proseal. J Anaesthesiol Clin Pharmacol. 2013 Jan;29(1):56-60. doi: 10.4103/0970-9185.105798.

  PMID: 23493414 BACKGROUND

• Verghese C, Brimacombe JR. Survey of laryngeal mask airway usage in 11,910 patients: safety and efficacy for conventional and nonconventional usage. Anesth Analg. 1996 Jan;82(1):129-33. doi: 10.1097/00000539-199601000-00023.

  PMID: 8712387 BACKGROUND

• Keller C, Sparr HJ, Luger TJ, Brimacombe J. Patient outcomes with positive pressure versus spontaneous ventilation in non-paralysed adults with the laryngeal mask. Can J Anaesth. 1998 Jun;45(6):564-7. doi: 10.1007/BF03012709.

  PMID: 9669012 BACKGROUND

• Tokioka H, Nagano O, Ohta Y, Hirakawa M. Pressure support ventilation augments spontaneous breathing with improved thoracoabdominal synchrony in neonates with congenital heart disease. Anesth Analg. 1997 Oct;85(4):789-93. doi: 10.1097/00000539-199710000-00013.

  PMID: 9322456 BACKGROUND

• Farias JA, Frutos F, Esteban A, Flores JC, Retta A, Baltodano A, Alia I, Hatzis T, Olazarri F, Petros A, Johnson M. What is the daily practice of mechanical ventilation in pediatric intensive care units? A multicenter study. Intensive Care Med. 2004 May;30(5):918-25. doi: 10.1007/s00134-004-2225-5. Epub 2004 Mar 17.

  PMID: 15029473 BACKGROUND

• Brimacombe J, Keller C, Hormann C. Pressure support ventilation versus continuous positive airway pressure with the laryngeal mask airway: a randomized crossover study of anesthetized adult patients. Anesthesiology. 2000 Jun;92(6):1621-3. doi: 10.1097/00000542-200006000-00019.

  PMID: 10839911 BACKGROUND

• von Goedecke A, Brimacombe J, Hormann C, Jeske H-, Kleinsasser A, Keller C. Pressure support ventilation versus continuous positive airway pressure ventilation with the ProSeal laryngeal mask airway: a randomized crossover study of anesthetized pediatric patients. Anesth Analg. 2005 Feb;100(2):357-360. doi: 10.1213/01.ANE.0000143563.39519.FD.

  PMID: 15673856 BACKGROUND

• Lim B, Pawar D, Ng O. Pressure support ventilation vs spontaneous ventilation via ProSeal laryngeal mask airway in pediatric patients undergoing ambulatory surgery: a randomized controlled trial. Paediatr Anaesth. 2012 Apr;22(4):360-4. doi: 10.1111/j.1460-9592.2012.03819.x.

  PMID: 22380745 BACKGROUND

MeSH Terms

Conditions

Microcephaly, Primary Autosomal Recessive, 6

Study Officials

• Golnar Se Hammouda, M.D

  Professor of Anesthesia Intensive Care Faculty of Medicine - Mansoura University

  STUDY CHAIR

• Hanaa Ma El-Bendary, M.D

  Assistant Professor of Anesthesia Intensive Care Faculty of Medicine - Mansoura University

  STUDY DIRECTOR

• Marwa Ib Abdo, M.D

  Lecturer of Anesthesia Intensive Care Faculty of Medicine - Mansoura University

  PRINCIPAL INVESTIGATOR

• Bahaa Mo Ezz, MBBCh

  Resident of Anesthesia Intensive Care Mansoura University Hospitals

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marwa Ib Abdo, M.D

CONTACT

01002477789; marwaibr79@yahoo.com

Marwa Ib Abdo, M.D

CONTACT

01556660553; marwaibr792000@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Anesthesia and Surgical Intensive Care-Faculty of Medicine - Mansoura University

Model Details: a prospective cross\_over study

Study Record Dates

• First Submitted: August 20, 2021
• First Posted: November 11, 2021
• Study Start: March 31, 2019
• Primary Completion: December 28, 2021
• Study Completion: October 15, 2022
• Last Updated: November 19, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)