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Obese patients are at increased risk of low oxygen levels during the induction of general anesthesia. Preoxygenation with a face mask before anesthesia is routinely used to increase oxygen reserves. This study compares three preoxygenation techniques: deep breathing alone, deep breathing with pressure-supported ventilation, and deep breathing with pressure-supported ventilation plus positive end-expiratory pressure (PEEP).
The main goal of the study is to determine how quickly each technique allows patients to reach an adequate level of oxygen in the lungs. In addition, the study evaluates whether these techniques cause gastric distension, which could increase the risk of regurgitation. Gastric ultrasound is used to assess stomach size before and after preoxygenation.
The results of this study will help identify the most effective and safest method of preoxygenation in obese patients undergoing elective surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DB (Deep Breathing) | Experimental | Deep breathing preoxygenation with 100% oxygen at 12 L/min using. |
|
| DB+PSV | Experimental | Preoxygenation with deep breathing supported by pressure-supported ventilation (PSV-Pro) with 12 cmH₂O pressure support and 100% oxygen at 12 L/min until EtO₂ reached 90%. |
|
| DB+PSV+PEEP | Experimental | Deep breathing preoxygenation supported by PSV-Pro (pressure support 12 cmH₂O) with the addition of PEEP 6 cmH₂O; 100% oxygen at 12 L/min. This arm differs from Arm 2 by the application of PEEP. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Deep Breathing Preoxygenation | Procedure | Preoxygenation performed with deep breathing using a ventilator delivering 100% oxygen at a flow rate of 12 L/min. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to reach an end-tidal oxygen concentration (EtO₂) of 90% | The time, in seconds, from the start of preoxygenation until the end-tidal oxygen concentration (EtO₂) reached 90%. End-tidal oxygen was measured at 30-second intervals using the anesthesia machine gas analyzer. Reaching EtO₂ 90% was defined as the endpoint of the preoxygenation period. | Periprocedural (during the preoxygenation period, prior to induction of anesthesia) |
| Measure | Description | Time Frame |
|---|---|---|
| Heart rate | Heart rate was measured at baseline (before the start of preoxygenation) and at the end of the preoxygenation period, defined as the time point when end-tidal oxygen concentration (EtO₂) reached 90%. | Periprocedural (baseline and pre-induction) |
| Gastric antral cross-sectional area |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pamukkale University | Denizli | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26716862 | Result | Abou-Arab O, Guinot PG, Dimov E, Diouf M, de Broca B, Biet A, Zaatar R, Bernard E, Dupont H, Lorne E. Low-positive pressure ventilation improves non-hypoxaemic apnoea tolerance during ear, nose and throat pan-endoscopy: A randomised controlled trial. Eur J Anaesthesiol. 2016 Apr;33(4):269-74. doi: 10.1097/EJA.0000000000000394. | |
| 37077116 |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D011175 | Positive-Pressure Respiration |
| ID | Term |
|---|---|
| D012121 | Respiration, Artificial |
| D058109 | Airway Management |
| D013812 | Therapeutics |
| D012138 | Respiratory Therapy |
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Three-arm parallel-group randomized trial comparing deep breathing alone, deep breathing with pressure support, and deep breathing with pressure support plus PEEP for preoxygenation.
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| Pressure Support Ventilation | Procedure | Application of pressure support ventilation with a pressure support level of 12 cmH₂O during preoxygenation. |
|
| Positive End-Expiratory Pressure | Procedure | Application of positive end-expiratory pressure at a level of 6 cmH₂O during preoxygenation. |
|
Gastric antral cross-sectional area measured by ultrasonography using a 2-5 MHz convex probe, calculated as (anteroposterior diameter × craniocaudal diameter × π)/4. Measurements were performed at baseline (before the start of preoxygenation) and at the completion of the preoxygenation period, defined as the time point when end-tidal oxygen concentration (EtO₂) reached 90%. |
| Periprocedural (baseline and pre-induction) |
| Gastric distension score | Epigastric gastric distension assessed using a 4-point ordinal scale (0 = none, 1 = mild, 2 = moderate, 3 = marked). The score was recorded at baseline (before the start of preoxygenation) and at the completion of the preoxygenation period, defined as the time point when end-tidal oxygen concentration (EtO₂) reached 90%. | Periprocedural (baseline and pre-induction) |
| Reflux, belching, and discomfort | Patient-reported occurrence of discomfort, symptomatic gastroesophageal reflux, or belching during the preoxygenation period. Events were assessed and recorded at the completion of the preoxygenation period, defined as the time point when end-tidal oxygen concentration (EtO₂) reached 90%. | Periprocedural (baseline and pre-induction) |
| Systolic Blood Pressure | Systolic blood pressure measured noninvasively at baseline (before the start of preoxygenation) and at the completion of the preoxygenation period, defined as the time point when end-tidal oxygen concentration (EtO₂) reached 90%. | Periprocedural (baseline and pre-induction) |
| Diastolic Blood Pressure | Diastolic blood pressure measured noninvasively at baseline (before the start of preoxygenation) and at the completion of the preoxygenation period, defined as the time point when end-tidal oxygen concentration (EtO₂) reached 90%. | Pre-induction (baseline and at completion of preoxygenation, defined by EtO₂ reaching 90%) |
| Peripheral Oxygen Saturation (SpO₂) | Peripheral oxygen saturation (SpO₂) measured at baseline (before the start of preoxygenation) and at the completion of the preoxygenation period, defined as the time point when end-tidal oxygen concentration (EtO₂) reached 90%. | Periprocedural (baseline and pre-induction) |
| Taxak S, Gupta M, Bala R, Govil V, Lallar A. A prospective randomized study to evaluate the efficacy of pressure support ventilation with and without positive end expiratory pressure for preoxygenation in adult patients. Med Gas Res. 2023 Oct-Dec;13(4):187-191. doi: 10.4103/2045-9912.372665. |
| 26225498 | Result | Hanouz JL, Lammens S, Tasle M, Lesage A, Gerard JL, Plaud B. Preoxygenation by spontaneous breathing or noninvasive positive pressure ventilation with and without positive end-expiratory pressure: A randomised controlled trial. Eur J Anaesthesiol. 2015 Dec;32(12):881-7. doi: 10.1097/EJA.0000000000000297. |
| 18931236 | Result | Delay JM, Sebbane M, Jung B, Nocca D, Verzilli D, Pouzeratte Y, Kamel ME, Fabre JM, Eledjam JJ, Jaber S. The effectiveness of noninvasive positive pressure ventilation to enhance preoxygenation in morbidly obese patients: a randomized controlled study. Anesth Analg. 2008 Nov;107(5):1707-13. doi: 10.1213/ane.0b013e318183909b. |
| 11323373 | Result | Nimmagadda U, Chiravuri SD, Salem MR, Joseph NJ, Wafai Y, Crystal GJ, El-Orbany MI. Preoxygenation with tidal volume and deep breathing techniques: the impact of duration of breathing and fresh gas flow. Anesth Analg. 2001 May;92(5):1337-41. doi: 10.1097/00000539-200105000-00049. |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |