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Comparative study of the outcome of oral versus nasal intubation in neonates and infants undergoing cardiac surgery

Comparative study of the outcome of oral versus nasal intubation in neonates and infants undergoing cardiac surgery

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
PACTR
Registry ID
PACTR202004476254378
Enrollment
200
Registered
2020-04-24
Start date
2020-04-22
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Anaesthesia

Interventions

Nasal Group
oral intubation Group

Sponsors

Mansoura university children hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: This study will be conducted on 200 patients of either sex with their age less than one year submitted for on pump cardiac surgery

Exclusion criteria

Exclusion criteria: Patients will be excluded from the current study in case of refusal of their guardians, redo cardiac surgery, congenital deformity of the nose and palate, presence of contraindication to nasal intubation, coagulation disorders, renal, hepatic or pulmonary disease, heart failure and moderate to severe pulmonary hypertension.

Design outcomes

Primary

MeasureTime frame
Total dose of postoperative fentanyl consumption during the first postoperative 24 hours.

Secondary

MeasureTime frame
1- Maximum heart rate [HR] and invasive mean arterial blood pressure [MAP] during intubation. 2-Time that will be taken for intubation (seconds). We will define an intubation duration as starting when the bag and mask ventilation stopped before intubation and terminating when the positive pressure ventilation (PPV) started after inserting the ET tube. 3-Minimum oxygen saturation during intubation. 4- Number of nasal intubation trials and number of failed nasal intubation. 5- Accidental extubation either spontaneous or during trans esophageal echo probe manipulation. 6- Occurrence of traumatic complications of nasal intubation (epistaxis). 7- Time to extubation (hours). 8- Intensive care unit (ICU) and hospital length of stays. 9- Post-operative complications (the need for re-intubation, stridor, pneumonia, wound infection)

Countries

Egypt

Contacts

Public ContactNabil Abd Elraouf

Professor of anesthesia and surgical Intensive care at faculty of medicine Mansoura university

nabil_abdelraouf@yahoo.com+201001538648

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Aug 9, 2026