The Role of Periodic Alveolar Recruitment Maneuvers in Intraoperative Protective Ventilation

NCT ID: NCT05962125

Last Updated: 2024-12-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-21
• Study Completion Date: 2023-12-31

Brief Summary

The goal of this clinical trial is to compare three open-lung strategies on respiratory function and lung injury in protective ventilation for laparoscopic anterior resection. It aims to answer whether a periodic alveolar recruitment maneuvers (PARM) strategy alone was an appropriate open-lung strategy in intraoperative protective ventilation. Patients were randomly assigned (1:1:1) to receive one of three open-lung strategies in protective ventilation: PARM alone (alveolar recruitment maneuvers [ARM] repeated every 30 min), positive end-expiratory pressure (PEEP) alone (a PEEP of 6 to 8 cm H2O), or a combination of PEEP and PARM (a PEEP of 6 to 8 cm H2O combined with ARM repeated every 30 min). The primary outcome is the mechanical power before the end of intraoperative mechanical ventilation. Secondary outcomes included the accumulative intraoperative mechanical power, an arterial partial pressure of oxygen (PaO2) / inhaled oxygen concentration (FiO2) ratio (P/F ratio) before the end of intraoperative mechanical ventilation, the rates of respiratory failure at post-anesthesia care unit (PACU) and three postoperative days, the concentration of soluble advanced glycation end products receptor (sRAGE) and Clara cell protein 16 (CC16) at the end of surgery, postoperative pulmonary complications score, postoperative hospitalization days and so on.

Conditions

Mechanical Power; Alveolar Recruitment Maneuvers; Protective Ventilation; Postoperative Pulmonary Complications

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

periodic alveolar recruitment maneuvers (PARM) alone

Alveolar recruitment maneuvers \[ARM\] repeated every 30 min after tracheal intubation and after any disconnection from the ventilator.

Group Type: EXPERIMENTAL

periodic alveolar recruitment maneuvers

Intervention Type: OTHER

A stepwise increment of tidal volume was used for each ARM.

positive end-expiratory pressure (PEEP) alone

PEEP was routinely set at 6 cm H2O. If it was in a state of Trendelenburg position or carbon dioxide pneumoperitoneum, PEEP was set to 8 cm H2O.

Group Type: ACTIVE_COMPARATOR

positive end-expiratory pressure

Intervention Type: OTHER

a PEEP of 6 to 8 cm H2O

a combination of PEEP and PARM

Alveolar recruitment maneuvers \[ARM\] repeated every 30 min after tracheal intubation and after any disconnection from the ventilator. PEEP was routinely set at 6 cm H2O. If it was in a state of Trendelenburg position or carbon dioxide pneumoperitoneum, PEEP was set at 8 cm H2O.

Group Type: ACTIVE_COMPARATOR

periodic alveolar recruitment maneuvers

Intervention Type: OTHER

A stepwise increment of tidal volume was used for each ARM.

positive end-expiratory pressure

Intervention Type: OTHER

a PEEP of 6 to 8 cm H2O

Interventions

periodic alveolar recruitment maneuvers

A stepwise increment of tidal volume was used for each ARM.

Intervention Type: OTHER

positive end-expiratory pressure

a PEEP of 6 to 8 cm H2O

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Undergoing elective laparoscopic anterior resection and expected duration of mechanical ventilation 2 to 5 h.

2. Had an intermediate risk of developing postoperative pulmonary complications.

3. Pulse oxygen saturation in room air ≥ 94%.

4. Aged 60 to 80 years.

Exclusion Criteria

• 1. Had received invasive mechanical ventilation for longer than 1 h within the last 2 weeks prior to surgery.

2. Had a history of pneumonia within 1 month prior to surgery. 3. Had severe chronic obstructive pulmonary disease or pulmonary bullae. 4. Had a progressive neuromuscular illness. 5. With an American Society of Anesthesiologists (ASA) physical status of IV or higher.

6. Intracranial hypertension. 7. Body mass index (BMI) ≥30 kg/m2. 8. Were involved in other interventional studies.

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sixth Affiliated Hospital, Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hong Li, MD

Role: PRINCIPAL_INVESTIGATOR

The Sixth Affiliated Hospital, Sun Yat-sen University

Locations

The Sixth Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China

Countries

China

Other Identifiers

E2023069

Identifier Type: -

Identifier Source: org_study_id