Application of Protective Ventilation Improves Oxygenation During and After Anesthesia. Is it Possible That a Special Procedure, an Oxygenation Test, Can Replace Arterial Blood Gases When Evaluating Oxygenation?
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Region Västmanland
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Change in peripheral O2 saturation(SpO2)during and 1 hour after anesthesia in comparison to awake before anesthesia.
Study Overview
Brief Summary
The study investigates if applying a special ventilatory strategy during anesthesia for laparoscopic gastric by pass, produces less atelectasis and better oxygenation in spite of using 100 % oxygen during pre oxygenation and induction of anesthesia. The study investigates oxygenation with blood gas samples but also with a new method that might give more information without the use of blood gas samples.
Primary: Oxygenation in patients with morbid obesity improves if preoxygenation, induction and maintenance of anesthesia is performed with either a continuous positive airway pressure (CPAP) or a positive end expiratory pressure (PEEP), respectively, of 10 cm H2O, in comparison to a technique without CPAP but with a PEEP of 10 cm H2O.
Secondary: The improved oxygenation during anesthesia can be prolonged inte the postoperative period if emergence from anesthesia is performed without high levels of oxygen.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Factorial
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Adult patients scheduled for elective surgery of Morbid Obesity.
- •(ASA = American Society of Anesthesiologists classification).
- •"Body mass index" (BMI) ≥ 35 but < 50
Exclusion Criteria
- •Anticipated difficult intubation.
- •Major bleeding.
- •Problems with ventilation necessitating protocol aberrations.
- •Obstructive sleep apnea syndrome with CPAP treatment at home.
- •Angina Pectoris
Arms & Interventions
Start O2 100% and CPAP 10, end O2 100%.
This arm describes some aspects of ventilation during anesthesia for laparoscopic gastric bypass. Pre-oxygenation is with an inspiratory oxygen fraction(FIO2) of 1.0, supplied by a continuous positive airway pressure of 10 centimeters of water(cmH2O), during anesthesia a positive end-expiratory pressure of 10 cmH2O is used and during emergence from anesthesia a FIO2 of 1.0 is used. The intervention associated with this arm is labeled CPAP and 100% oxygen.
Intervention: CPAP and 100% oxygen (Procedure)
Start O2 100% and CPAP 10, end O2 31%.
This arm describes some aspects of ventilation during anesthesia for laparoscopic gastric bypass. Pre-oxygenation is with a FIO2 of 1.0, supplied by a continuous positive airway pressure of 10 cmH2O, during anesthesia a positive end-expiratory pressure of 10 cmH2O is used and during emergence from anesthesia a FIO2 of 0.3 is used. The intervention associated with this arm is labeled CPAP and 31% oxygen.
Intervention: CPAP and 31% oxygen (Procedure)
Start O2 100% and CPAP 0, end O2 100%.
This arm describes some aspects of ventilation during anesthesia for laparoscopic gastric bypass. Pre-oxygenation is with a FIO2 of 1.0, without a continuous positive airway pressure, during anesthesia a positive end-expiratory pressure of 10 cmH2O is used and during emergence from anesthesia a FIO2 of 1.0 is used. The intervention associated with this arm is labeled No CPAP and 100% oxygen.
Intervention: No CPAP and 100% oxygen (Procedure)
Outcomes
Primary Outcomes
Change in peripheral O2 saturation(SpO2)during and 1 hour after anesthesia in comparison to awake before anesthesia.
Time Frame: Change in SpO2 from 5 min before start of anesthesia, to 5 min after intubation, 5 min before extubation and 1 hour after extubation.
During anesthesia SpO2 is measured at three different levels of oxygen; 21, 26 and 31 % respectively as long as SpO2 does not go lower than 87 % and compared to SpO2 immediately before anesthesia. SpO2 breathing air one hour after anesthesia is compared to SpO2 before anesthesia.
Secondary Outcomes
- Arterial blood gas values for saturation (SaO2)(5 min before anesthesia, 5 min after intubation, 5 min before extubation and 1 hour after anesthesia.)
- Arterial oxygen tension (PaO2)(5 min before start of anesthesia, 5 min after intubation, 5 min before extubation and 1 hour after extubation.)
Investigators
Lennart Edmark
Principal Investigator
Region Västmanland