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Stepwise PEEP vs Sustained Inflation in Bariatric Surgery Patients

ConditionsRecruitmentBariatric Surgery Candidate
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAin Shams University

About this trial

Male and female patients Undergoing laparoscopic bariatric surgeries will be subjected for lung recruitment at end of surgery before emergence from anesthesia by two different methods . to evaluate which might be safer and more effective

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Anesthesiologists (ASA) physical status II, of either sex Age ≥18 y.

Undergoing laparoscopic bariatric surgeries; sleeve gastrectomy, mini gastric bypass

BMI (35-60)

Disqualifiers

Pre-existing severe pulmonary disease

Baseline hypoxemia SpO₂ <92% on room air

History of barotrauma

Previous pneumothorax

Trial design

Design model

Parallel

Treatments tested in this trial

  • sustained inflation recruitement

    Procedure/Surgery

    anesthesiologist adjust the ventilator to manual ventilation mode and ad¬just The ventilator was switched to manual mode, and the airway pressure-limiting valve was set to 30 cmH₂O. A sustained manual inflation was then applied by gradually squeezing the anesthesia reservoir bag over 3-5 seconds until a peak airway pressure (Ppeak) of 30 cmH₂O

  • Stepwise PEEP

    Procedure/Surgery

    : ventilation will be set to pressure control mode and the driving pressure maintained at 10 cmH2O with an initial PEEP of 5 cmH2O, respiratory rate 8-10, I:E 1-1PEEP will be then increased by 5 cmH2O ev¬ery 30 s until the Ppeak reached 30 cmH2O

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: group SIActive comparator 1 intervention
Group B: group IPActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Postoperative lung aeration

limited-zone lung ultrasound scoring system

Time frame
in the post-anesthesia care unit 15 minutes after extubation

Secondary outcomes

1

Postoperative oxygenation

SpO₂

Time frame
in the post-anesthesia care unit 15 minutes after extubation
2

Oxygen requirement in PACU

to maintain SpO₂ ≥94%.

Time frame
in the post-anesthesia care unit 15 minutes after extubation

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ain Shams University

Lead sponsor

Source ClinicalTrials.gov
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