Clinical trial NCT04872361: Which Ventilatory Strategy is Better for Lung in Upper Abdominal Surgeries?
Official title: Ultrasonographic Assessment of Atelectasis in Major Upper Abdominal Surgeries With Different Ventilatory Strategies
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anesthesia Induced Atelectasis
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2021-05-04
Enrollment: 117
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Ventilated Patients especially those undergoing upper abdominal surgeries are prone to lung atelectasis. They are at risk of adverse effects secondary to inadequate lung ventilation.

Applied PEEP and Recruitment maneuver are thought to enhance lung aeration under general anesthesia which could be assessed by ultrasound.

Detailed description: The aim of our study is to assess the effect of using PEEP with and without recruitment maneuver on atelectasis and lung aeration during open upper abdominal surgeries by ultrasonography.

Application of PEEP improves intraoperative oxygenation and thus could minimize the incidence of postoperative atelectasis and respiratory complications during abdominal surgeries.

A recent study found that PEEP and RM prevented intraoperative aeration loss, which didn't persist after extubation when comparing effects of positive end-expiratory pressure/recruitment maneuvers with zero end-expiratory pressure on atelectasis during open gynecological surgery by ultrasonography

Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists' physical status grades I, II, and III.

Exclusion Criteria:

* Patient refusal.
* Psychiatric diseases.
* Body Mass Index \> 35 Kg/m2.
* Previous intrathoracic procedures.
* History of severe obstructive pulmonary disease.
* History of severe restrictive lung disease.
* Pulmonary arterial hypertension ( systolic pulmonary arterial pressure \>40 mmHg).
* Pregnancy.

Primary outcomes:
measure: Pre-emergence LUS score
timeFrame: intraoperative before recovery from anesthesia
Secondary outcomes:
measure: Lung ultrasonography score (LUS score)
timeFrame: preoperative, intraoperative for anesthesia duration to 1 hour postoperative
measure: Heart rate
timeFrame: preoperative, intraoperative for anesthesia duration to 1 hour postoperative
measure: Mean blood pressure
timeFrame: preoperative, intraoperative to 1 hour postoperative
measure: oxygen saturation
timeFrame: preoperative, intraoperative to 1 hour postoperative
measure: End-tidal carbon dioxide tension
timeFrame: intraoperative for anesthesia duration
measure: Arterial partial pressure of oxygen (PaO2)
timeFrame: Intraoperative and 15 min postoperative
measure: Arterial partial pressure of carbon dioxide (PaCO2)
timeFrame: Intraoperative and 15 min postoperative
measure: PaO2/FiO2
timeFrame: Intraoperative and 15 min postoperative
measure: Peak inspiratory pressure
timeFrame: intraoperative for anesthesia duration
measure: Postoperative pulmonary complications (PPCs)
timeFrame: 5 days
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura University
state: DK
Study officials:
affiliation: Professor of Anesthesia and Surgical Intensive Care
name: Aboelnour E Badran, MD
role: STUDY_CHAIR
affiliation: Assistant Professor of Anesthesia and Surgical Intensive Care
name: Hanaa M EL- Bendary, MD
role: STUDY_DIRECTOR
References: