Trial no.:	PACTR202207544042341	Date of Registration:	22/07/2022
Trial Status:	Retrospective registration - This trial was registered after enrolment of the first participant

TRIAL DESCRIPTION

Public title

High versus Low PEEP in Open Upper Abdominal Surgeries

Official scientific title

High versus Low PEEP in Open Upper Abdominal Surgeries

Brief summary describing the background and objectives of the trial

During general anaesthesia, the use of invasive mechanical ventilation can result in atelectasis and reduction in both lung volume and muscle tone and impairs post-operative lung function. The risk of atelectasis increases in abdominal surgeries especially the nearer the incision to diaphragm. Atelectasis can result in intra-operative impairment of oxygenation and post-operative change in lung aeration and pulmonary function recovery (Treschan et al., 2017). Post-operative pulmonary complications (PPCs), are at least as frequent as cardiac complications during non-cardiac surgery and are associated with increased risk of in-hospital death, particularly after open upper abdominal surgeries (PROVE, 2014). Post-operative recovery of pulmonary function could depend, at least in part, on the intra-operative ventilation strategy. Mechanical ventilation might affect the incidence of post-operative pulmonary complications and, possibly, distal organ dysfunction. The protective role of PEEP in preventing PPCs was challenged recently as it may be associated with less intratidal recruitment and derecruitment. Use of very low levels of PEEP could lead to atelectasis, while high levels of PEEP, however might not only provoke complications such as intra-operative circulatory depression but also promote hyperinflation (D’Antini et al., 2017). We designed this study to test the hypothesis that a ventilation strategy with a high level of PEEP during general anaesthesia for open upper abdominal surgery protects against post-operative pulmonary complications in patients at risk for complications measured by intra-operative ventilation and oxygenation parameters and lung ultrasonography.

Type of trial

RCT

Acronym (If the trial has an acronym then please provide)

Disease(s) or condition(s) being studied

Anaesthesia,Respiratory

Sub-Disease(s) or condition(s) being studied

Purpose of the trial

Prevention

Anticipated trial start date

02/04/2018

Actual trial start date

02/04/2018

Anticipated date of last follow up

01/04/2019

Actual Last follow-up date

01/04/2019

Anticipated target sample size (number of participants)

60

Actual target sample size (number of participants)

60

Recruitment status

Completed

Publication URL

Secondary Ids	Issuing authority/Trial register

STUDY DESIGN
Intervention assignment	Allocation to intervention	If randomised, describe how the allocation sequence was generated	Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms	Masking	If masking / blinding was used
Parallel: different groups receive different interventions at same time during study	Randomised	Simple randomization using by using procedures such as coin-tossing or dice-rolling	Sealed opaque envelopes	Masking/blinding used	Outcome Assessors

INTERVENTIONS
Intervention type	Intervention name	Dose	Duration	Intervention description	Group size	Nature of control
Experimental Group	High PEEP	High PEEP of 12 cm H2O.	More than 2 hours intraoperatively	Patients will undergo intra-operative lung-protective mechanical ventilation with protective low VT of 6-8 ml/kg, and they will be randomly assigned into 3 groups using closed envelope method: Group (A) receiving high PEEP 12 cm H2O.	20
Experimental Group	Low PEEP	PEEP 6 cm H2O	Surgery exceeding 2 hours	Patients will undergo intra-operative lung-protective mechanical ventilation with protective low VT of 6-8 ml/kg, and they will be randomly assigned into 3 groups using closed envelope method: Group (B) receiving PEEP 6 cm H2O.	20
Control Group	Zero PEEP	Zero PEEP (ZEEP	Surgery exceeding 2hours	Patients will undergo intra-operative lung-protective mechanical ventilation with protective low VT of 6-8 ml/kg, and they will be randomly assigned into 3 groups using closed envelope method: Group (C) receiving Zero PEEP (ZEEP).	20	Dose Comparison

ELIGIBILITY CRITERIA
List inclusion criteria	List exclusion criteria	Age Category	Minimum age	Maximum age	Gender
-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.	-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.	Adult: 18 Year(s)-44 Year(s),Middle Aged: 45 Year(s)-64 Year(s)	18 Year(s)	55 Year(s)	Both

ETHICS APPROVAL

Has the study received appropriate ethics committee approval

Date the study will be submitted for approval

Date of approval

Name of the ethics committee

Yes

02/04/2018

Research Ethics Committee at the faculty of Medicine Ain Shams University

Ethics Committee Address
Street address	City	Postal code	Country
Abbasia	Cairo	1181	Egypt

OUTCOMES
Type of outcome	Outcome	Timepoint(s) at which outcome measured
Primary Outcome	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.	Within first five postoperative days.
Secondary Outcome	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).	pre-operatively, intra-operatively and post-operatively
Secondary Outcome	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.	Intraoperatively
Secondary Outcome	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.	Postoperatively

RECRUITMENT CENTRES
Name of recruitment centre	Street address	City	Postal code	Country
Ain Shams University Educational Hospitals	38 Abbassia	Cairo	1181	Egypt

FUNDING SOURCES
Name of source	Street address	City	Postal code	Country
Mohamed Alaaeldin Mohamed Elsayed Radwan	56 Harley Road	Manchester	M33 7FP	United Kingdom

SPONSORS
Sponsor level	Name	Street address	City	Postal code	Country	Nature of sponsor
Primary Sponsor	Ain Shams university hospitals	Abbasia	Cairo		Egypt	University

COLLABORATORS
Name	Street address	City	Postal code	Country
Dr. Amr Mohamed ELSaid Kamel	Abbasia	Cairo		Egypt

CONTACT PEOPLE
Role	Name	Email	Phone	Street address
Principal Investigator	Mohamed Alaaeldin Mohamed Elsayed Radwan	m.alaa@med.asu.edu.eg	+4473565063221	56 Harley Road
City	Postal code	Country	Position/Affiliation
Manchester	M33 7FP	United Kingdom	Assiatant lecturer Ain Shams university Hospitals
Role	Name	Email	Phone	Street address
Public Enquiries	Mohamed Alaaeldin Mohamed Elsayed Radwan	m.alaa@med.asu.edu.eg	+447365063221	56 Harley Road
City	Postal code	Country	Position/Affiliation
Manchester		United Kingdom	Assistant lecturer
Role	Name	Email	Phone	Street address
Scientific Enquiries	Mohamed Alaaeldin Mohamed Elsayed Radwan	m.alaa@med.asu.edu.eg	+447365063221	56 Harley Road
City	Postal code	Country	Position/Affiliation
Manchester	M33 7FP	United Kingdom	Assitant Lecturer

REPORTING
Share IPD	Description	Additional Document Types	Sharing Time Frame	Key Access Criteria
Yes	Individual participant data that will underline the results reported in this protocol after deidentification.	Study Protocol	9 months starting from July 2022	Investigators whose proposed use of the data has been approved by an independent review committee.
URL	Results Available	Results Summary	Result Posting Date	First Journal Publication Date
	No
Result Upload 1:	Result Upload 2:	Result Upload 3:	Result Upload 4:	Result Upload 5:

Result URL Hyperlinks	Link To Protocol
Result URL Hyperlinks

Changes to trial information

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