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High versus Low PEEP in Open Upper Abdominal Surgeries

High versus Low PEEP in Open Upper Abdominal Surgeries

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
PACTR
Registry ID
PACTR202207544042341
Enrollment
60
Registered
2022-07-22
Start date
2018-04-02
Completion date
Unknown
Last updated
2026-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory Anaesthesia

Interventions

Sponsors

Ain Shams university hospitals
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: -Age: From 18 years till 55 years. -Sex: Male or Female. -Expected duration of surgery (from incision to closure) exceeds 2 h. -To identify the risk for PPCs, the Assess Respiratory Risk in Surgical Patients in Catalonia (ARISCAT) score is used (Canet el al., 2010). This score predicts individual preoperative risk for PPCs using seven independent predictors, four of which are patient-related and three of which are surgery-related. An ARISCAT risk score =26 is associated with an intermediate to high risk for PPCs.

Exclusion criteria

Exclusion criteria: -Age: below 18 years or above 55 years. -Patient refusal to give written informed consent. -Pregnant patients. -Patients with persistent hemodynamic instability or intractable shock. -Patients with a history of severe chronic obstructive pulmonary disease (COPD); defined as non-invasive ventilation and/or oxygen therapy at home or repeated systemic corticosteroid therapy for acute exacerbations of COPD), severe cardiac disease (defined as New York Heart Association class III or IV, acute coronary syndrome, or persistent ventricular tachyarrhythmia), concurrent acute respiratory distress syndrome (ARDS) expected to require prolonged post-operative mechanical ventilation, severe pulmonary arterial hypertension (defined as systolic pulmonary arterial pressure >40 mmHg). -Patients with intracranial injury, or tumour or neuromuscular disease. -Morbid obesity: obese patients with BMI =35 kg/m2. -Patients who have undergone any kind of previous lung surgery, have been invasively mechanically ventilated for longer than 30 minutes within the last 30 days before surgery, or have received recent immunosuppressive medication (chemotherapy or radiation therapy up to 2 months prior to surgery). -Need for one-lung ventilation or planned re-intubation following surgery, or need for intra-operative prone or lateral decubitus position.

Design outcomes

Primary

MeasureTime frame
The primary endpoint of this trial is the development of PPCs within the first 5 post-operative days. Patients who develop a least one complication are considered as meeting the primary endpoint. PPCs are defined as follows: respiratory failure, ARDS, Bronchospasm, Pulmonary infection, Aspiration pneumonitis, Pleural effusion, Atelectasis, Cardiopulmonary edema, Pneumothorax.

Secondary

MeasureTime frame
Alveolar PO2 will be calculated from the alveolar gas equation: PAO2 = FiO2 (PB - PH2O) where PAO2 is partial pressure of alveolar O2, PiO2 is partial pressure of inspired O2, PB is barometric atmospheric pressure (760 mm Hg), and PH2O is partial pressure of water vapor (47 mm Hg at normal body temperature).which will need arterial blood gas samples to be taken pre-operatively, intra-operatively and post-operatively to measure partial pressure of oxygen (PaO2) and to calculate alveolo-arterial PaO2 gradient (A-a PaO2). ; Both surgery- and anaesthesia-related data are recorded, including duration of surgery (from incision to closure), patient positioning during operation, duration of anaesthesia (from intubation to extubation), anaesthetic procedure details, drugs and fluids administered during anaesthesia (e.g., anaesthetics, vasoactive drugs, transfusion). Ventilator settings, haemodynamics, need for rescue strategy and deviation from the ventilation protocol. ;length of stay in the PACU, Visual Analogue Score, post-operative analgesic requirements and the use of a non-rebreathing O2 mask (100% FiO2) or reintubation are also recorded.

Countries

Egypt

Contacts

Public ContactMohamed Alaaeldin Mohamed Elsayed Radwan

Assistant lecturer

m.alaa@med.asu.edu.eg+447365063221

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Feb 4, 2026