respiratory care and postoperative pulmonary complications

The Impact of a Prophylactic Respiratory Support Bundle (High-Flow Nasal Cannula and Early Structured Physiotherapy) on Postoperative Pulmonary Complications in High-Risk Abdominal Surgery Patients.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

PACTR

Registry ID

PACTR202606820734433

Enrollment

Registered

2026-06-18

Start date

2026-07-01

Completion date

Unknown

Last updated

2026-09-14

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

Conditions

Respiratory

Interventions

Prophylactic respiratory support bundle

standard care

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Surgical Procedure: • Scheduled for an elective, major abdominal surgery (open or laparoscopic), such as gastrectomy, colectomy, hepatectomy, or pancreatectomy. • Expected duration of surgery = 3 hours. 2. Patient Demographics & Status: • Age = 18 years. 3. Possesses at least TWO of the following high-risk factors: • Age = 65 years. • Body Mass Index (BMI) = 30 kg/m². • Documented mild-to-moderate chronic respiratory disease: Asthma or COPD classified as GOLD Stage 1 or 2. • No history of hypercapnic respiratory failure (PaCO2 > 45 mmHg) and not be on chronic home non-invasive ventilation (NIV). • Current smoker with a history of = 10 pack-years. • Expected duration of surgery = 3 hours

Exclusion criteria

Exclusion criteria: • Emergency surgery. • Pre-existing need for home oxygen or NIV (beyond the mild-moderate COPD specified). • Severe cardiac disease (e.g., NYHA Class III/IV). • Inability to provide informed consent. • Pregnancy. • Contraindications to HFNC or physiotherapy (e.g., recent facial/basal skull fracture). • Surgery involving the diaphragm or esophagus

Design outcomes

Primary

Measure	Time frame
Incidence of postoperative pulmonary complications (PPCs) diagnosed using the Melbourne Group Scale version 2 (MGS-2) requiring =4 criteria within the same 24-hour period (includes chest infection, atelectasis, bronchospasm, hypoxemia, etc.)	—

Secondary

Measure	Time frame
SpO2/FiO2 ratio ;ROX index ;Time to first successful out-of-bed mobilization (sitting in chair >5 minutes) ;Incidence of unplanned ICU admission Up to hospital discharge;Incidence of re-intubation ;Postoperative hospital length of stay ;Feasibility outcomes: recruitment rate, protocol adherence (HFNC hours delivered, physiotherapy sessions completed), attrition rate, adverse events (hypercapnia, HFNC intolerance);Hypercapnic respiratory deterioration (PaCO2 >50 mmHg with pH 10 mmHg from baseline)	—

Measure

Time frame

SpO2/FiO2 ratio ;ROX index ;Time to first successful out-of-bed mobilization (sitting in chair >5 minutes) ;Incidence of unplanned ICU admission Up to hospital discharge;Incidence of re-intubation ;Postoperative hospital length of stay ;Feasibility outcomes: recruitment rate, protocol adherence (HFNC hours delivered, physiotherapy sessions completed), attrition rate, adverse events (hypercapnia, HFNC intolerance);Hypercapnic respiratory deterioration (PaCO2 >50 mmHg with pH 10 mmHg from baseline)

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Countries

Egypt

Contacts

Public Contactkhaled gaballah

assistant professor of anesthesia and intensive care medicine

khgaballah@gmail.com00201016009073

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Sep 19, 2026