Pressure Support Ventilation Versus Continuous Positive Air Way Pressure (CPAP) Using I Gelin Adult Patients,
NCT ID: NCT05116839
Last Updated: 2021-11-19
Study Results
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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UNKNOWN
NA
38 participants
INTERVENTIONAL
2019-03-31
2022-10-15
Brief Summary
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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 .
Detailed Description
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Participants:
38 Adult patients with American Society of Anesthesiologists (ASA) physical status (I - II )of both sexes aged (18-65) years scheduled for minor surgery at Urology and Nephrology centre (UNC) will be included in this study.
The Patients with a body mass index (BMI) \>40 or having obstructive air way disease will be excluded.
All patients will be assessed on the day before surgery by detailed history thorough clinical examination, and basal laboratory investigations \[Complete blood count (CBC), Coagulation profile (prothrombin time and INR), liver and renal function tests (liver enzymes, bilirubin, albumin and s. creatinine\], electrocardiograph (ECG) and echo cardiography when needed.
Anaesthesia Induction of anaesthesia with fentanyl 0.5µg/kg - propofol 1mg/kg prior for insertion of device,primary success rate will be recorded.
Maintenance of anaesthesia by sevoflurane inhalation with minimal alveolar concentration (MAC) 2%.
All patients will breath spontaneously from ventilators (Dragers - Primal - germany).
All patients will breath at the first 15 minutes with PSV:triggered by minute volume \<3 liter,with no frequency 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). Adverse effects;Laryngeal spasm.Blood stained device. .
Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
OTHER
SINGLE
Study Groups
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the first 15 minutes with PSV
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
the first 15 minutes with pressure support ventilation
PSV pressure support ventilation:triggered by minute volume \< 3 Liter ,with no frequency
i gel air way
supraglottic air way device
the following 15 minutes ventilation will be changed to CPAP mode
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).
the following 15 minutes ventilation will be changed to continous positive air way pressureCPAP mode
continous positive air way pressure CPAP mode at 10 cm H2o .
i gel air way
supraglottic air way device
Interventions
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the first 15 minutes with pressure support ventilation
PSV pressure support ventilation:triggered by minute volume \< 3 Liter ,with no frequency
the following 15 minutes ventilation will be changed to continous positive air way pressureCPAP mode
continous positive air way pressure CPAP mode at 10 cm H2o .
i gel air way
supraglottic air way device
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
65 Years
ALL
No
Sponsors
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Mansoura University
OTHER
Responsible Party
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Marwa Ibrahim Mohamed Abdo,MD
Lecturer of Anesthesia and Surgical Intensive Care-Faculty of Medicine - Mansoura University
Principal Investigators
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Golnar Se Hammouda, M.D
Role: STUDY_CHAIR
Professor of Anesthesia Intensive Care Faculty of Medicine - Mansoura University
Hanaa Ma El-Bendary, M.D
Role: STUDY_DIRECTOR
Assistant Professor of Anesthesia Intensive Care Faculty of Medicine - Mansoura University
Marwa Ib Abdo, M.D
Role: PRINCIPAL_INVESTIGATOR
Lecturer of Anesthesia Intensive Care Faculty of Medicine - Mansoura University
Bahaa Mo Ezz, MBBCh
Role: PRINCIPAL_INVESTIGATOR
Resident of Anesthesia Intensive Care Mansoura University Hospitals
Locations
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Marwa Ibrahim Mohamed abdo
Al Mansurah, , Egypt
Countries
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Central Contacts
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Facility Contacts
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Marwa Ib Abdo, M.D
Role: primary
Marwa Abdo, M.D
Role: backup
References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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MS/19.03.556
Identifier Type: -
Identifier Source: org_study_id