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Manual Valsalva Maneuver As a Preventive Measure of Postoperative Laryngospasm in Laryngomalacia Cases Undergoing Supraglottoplasty

ConditionsLaryngomalaciaLaryngospasm
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-6
SponsorSameh Fathy

About this trial

We hypothesized that manual valsalva maneuver prevent incidence of postoperative laryngospasm after supraglottoplasty for cases of congenital laryngomalacia.

Primary outcome: Incidence of postoperative stridor and laryngospasm Secondary outcome: incidence of reintubation, postoperative hemodynamics, duration of postoperative ICU and hospital stay

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Infants and children ASA I or II aging from 1 month age - 6 years undergoing supraglottoplasty

Disqualifiers

Parents refusal.

Patients with increased ICP

Patients with increased IOP

Trial design

Design model

Parallel

Treatments tested in this trial

  • Valsalva maneuver

    Procedure/Surgery

    Closure of the nose and mouth during expiration for 20 sec

Treatment groups

58 Participants
are divided into 2 treatment groups
Group A: Group CNo intervention 0 interventions
Group B: Group VActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of laryngospasm

Time frame
24 HOURS

Secondary outcomes

1

incidence of reintubation

Time frame
24 HOURS
2

Postoperative oxygen saturation measurement

Oxygen saturation (%) is recorded every 5 minutes

Time frame
1 HOUR
3

Incidence of postoperative nausea and vomiting

Time frame
24 HOURS
4

Duration of postoperative hospital stay

Time frame
24 HOURS

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sameh Fathy

Lead sponsor

Mansoura University

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: